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Exercise and Nutrition for Healthy AgeiNg (ENHANce)

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Home-based training program
High-quality protein supplement
Omega-3 fatty acid
Placebo protein powder
Placebo omega-3
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia, Nutrition, Protein, Vitamin D, Exercise, Older people, Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female persons with (pre)sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP): reduced muscle mass without (presarcopenia) or with (sarcopenia) reduced walking speed (≤ 0.8m/s) or muscle strength OR probable, confirmed or severe sarcopenia according to EWGSOP 2.
  2. 65 years or older;
  3. Community-dwelling elderly or assisted living;
  4. In case of one or more positive answer(s) on the health screen for exercise, subjects need approval of their general practitioner to participate in this randomized controlled trial (RCT).

    • Uncontrolled or unstable health problems
    • Uncontrolled pain or feeling unwell the day of the exercise
    • Recently diagnosed cardiovascular events
    • systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg
    • Resting tachycardia > 100 bpm
    • Uncontrolled atrial or ventricular arrhythmias
    • Unstable or acute heart failure
    • Lasting, increased pain following a previous session
    • Suspected acute injury
    • Recent injurious fall without medical assessment
    • Severe breathlessness or dizziness
    • Uncontrolled pulmonary problems
    • Rheumatoid arthritis flare up or acute systemic illness/infection
    • Unexplained lethargy

Exclusion Criteria:

  1. Impairments/diseases that impose problems to participation in the study;
  2. Allergy to milk or soy or peanut;
  3. Mini-Mental State Examination (MMSE) < 21;
  4. Terminal illness (prognosis < 6 months);
  5. Persons who followed a physical training program in the last 6 months (twice or more/week);
  6. Persons with a daily intake of > 1.5 g protein/kg body weight (BW)/day;
  7. Diagnosis of severe kidney disease (GFR < 30 ml/min) or diabetes mellitus;
  8. Unable to communicate in Dutch, English or French.

Sites / Locations

  • Gerontology and Geriatrics, Department of Public Health and Primary Care, KU LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Home-based training program

High-quality protein supplement

2 Anabolic interventions

3 Anabolic interventions

Placebo protein powder and omega-3

Arm Description

Home-based training program + protein placebo + omega-3 placebo

High-quality protein supplement + omega-3 placebo

Home-based training program and high quality protein supplement

Home-based training program, high-quality protein supplement and omega-3 fatty acids

Control group: protein placebo + omega-3 placebo

Outcomes

Primary Outcome Measures

Change in physical functioning
Change in SPPB score
Percentage of participants with change in physical functioning
the percentage of participants with more than 1 or 1 point increase in SPPB score.

Secondary Outcome Measures

Change in muscle mass (after intervention-baseline)
Appendicular lean mass will be measured with a whole-body DXA scan and by BIA.
Change in muscle strength (after intervention-baseline)
Muscle strength of the knee-extensor, knee-flexor and hip abductors will be measured by Biodex and hand grip strength with dynamometer.
Compliance to the exercise intervention, subjective
Compliance to the Otago program will be assessed by measure of: - The number of Otago sessions the participant performed divided by the number of Otago sessions the participants needed to perform. Likewise, this will be calculated for the walking program and for the integral exercise intervention.
Compliance to the exercise intervention, objective
Compliance to the Otago program will be assessed by measure of: - Monitor and diary: Length of exercise session (time). Pattern recognition of exercise groups by algorithm development
Compliance to the exercise intervention, subjective, detailed
Compliance to the Otago program will be assessed by measure of: - Diary: the reported intensity of the strength exercises
Compliance to the protein supplementation, objective
Compliance to protein supplementation: - The number of nutritional intakes the participant did divided by the number of intakes of nutritional supplement the participant was prescribed.
Compliance to the protein supplementation, subjective
Compliance to protein supplementation: - Count and weight returned powder boxes
Compliance to the protein supplementation objective
Compliance to protein supplementation: - N content in 8 24h urine samples by the Dumas method (28) to estimate rise in protein intake and Creatinine index to estimate the completion of the urine samples (29, 30)
Compliance to the omega-3 supplementation, subjective
Compliance to omega-3 supplement - Count returned capsules and placebo tablets
Compliance to the omega-3 supplementation, objective
Compliance to omega-3 supplement - Compliance to the omega- 3 supplement is assessed by counting the number of capsules during each study visit and by analysis of red blood cell (RBC) membrane fatty acid profile
Functional status: frailty
- Change in physical frailty stage defined by Fried et al (frail (3-5/5), prefrail (1-2/5), robust (0/5))
Functional status: activities of daily living
Change in activity of daily living (ADL) :Barthel-index
Functional status: balance
Change in balance (Mini-BESTest)
Functional status: change in physical activity
Change in PA by the MoveMonitor+ (MM+) (method under development in our research group)
Functional status: health-related quality of life
- Change in health-related quality of life, according to Short Form Health Survey (SF-36) questionnaire
Functional status: falls
- Number of falls and the circumstances, identified using weekly fall calendars + Falls Efficacy Scale International (FES-I)
Cognitive status: immediate and delayed memory, attention, language and visuospatial skills
- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): immediate and delayed memory, attention, language and visuospatial skills;
Cognitive status: inhibition
Stroop test (inhibition)
Cognitive status
- Maze test
Nutritional status: malnutrition
- Changes in numbers of participants with malnutrition, according to Mini Nutritional Assessment (MNA).
Nutritional status: nutrient intake
- Changes in nutrient intake, according to the four day food diary.
Patient reported benefits and adverse effects
Benefits and adverse effects are asked. Participants will describe their thoughts about the study, what they like and don't like.
Change in C reactive protein (CRP)
change in hs-CRP
Change in hemoglobin
Change in hemoglobin
Change in creatinine
Change in creatinine
Change in urea
Change in urea
Change in serum albumin
Change in serum albumin
Change in glucose
Change in glucose
Change in cholesterol (HDL, LDL, total, Triglycerides)
Change in cholesterol (HDL, LDL, total, Triglycerides)
Change in insulin
Change in insulin
Change in insulin like growth factor 1 (IGF-1)
Change in IGF-1
Change in 25-hydroxy-vitamin D
Change in 25-hydroxy-vitamin D
Change in creatinine kinase
Change in creatinine kinase
Change in indoxyl sulfate
Change in indoxyl sulfate
Change in interleukin 6 (IL-6)
Change in IL-6
Change in IL-1b
Change in IL-1b
Change in tumor necrosis factor alpha (TNF-alpha)
Change in TNF-alpha
Change in myostatin
Change in myostatin
Change in activin A
Change in activin A
Change in markers of muscle wasting
Change in markers of muscle wasting (MURF1, Atrogin1, FOXO3)
Change in markers of muscle regeneration
Change in markers of muscle regeneration (PAX7, Myogenic factor 5 (MYF5), myoblast determination protein (MyoD), Ki67, mammalian target of rapamycin (mTOR), AMPK)
Change in muscle histology
Change in muscle histology
Change in composition of gut microbiota
Change in composition of gut microbiota
Change in markers of intestinal inflammation
Change in markers of intestinal inflammation (fecal calprotectin, lactoferrin, S100A12)

Full Information

First Posted
August 7, 2018
Last Updated
May 9, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, VISTA-Life, Nestlé Health Science Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03649698
Brief Title
Exercise and Nutrition for Healthy AgeiNg
Acronym
ENHANce
Official Title
Exercise and Nutrition for Healthy AgeiNg: Anabolic Interventions for Older People With (Pre)Sarcopenia to Improve Physical Functioning, Muscle Mass and Muscle Strength and to Understand the Underlying Mechanisms of Action.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, VISTA-Life, Nestlé Health Science Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this randomized placebo-controlled 5-arm clinical trial is to evaluate the effect of combined anabolic interventions compared to single or placebo interventions on physical performance in community-dwelling (pre)sarcopenic elderly (≥ 65 years) and to determine the underlying mechanisms of action. Important secondary outcome measures are muscle mass, muscle strength, compliance to the interventions (exercise program, protein and omega-3 supplementation) and functional, cognitive and nutritional status.
Detailed Description
The aim of this randomized 5-arm clinical trial is to evaluate the effect of combined anabolic interventions compared to single or placebo interventions on physical performance in community-dwelling (pre)sarcopenic elderly (≥ 65 years) living in Belgium. Physical performance will be evaluated using the Short Physical Performance Battery (SPPB). Muscle mass will be measured using a dual energy x-ray absorptiometry (DXA) and/or bioelectrical impedance analysis (BIA). Muscle strength will be measured by the Biodex (knee-extensor and knee-flexor) and a 1 hand-held dynamometer. The trial will also determine the underlying mechanisms of action using blood measures (such as markers of inflammation and sarcopenia) and muscle biomarkers. Important secondary outcome measures are compliance to the exercise program and to the protein and omega-3 supplementation, as well as functional, cognitive and nutritional status and the patients report on benefits and adverse events. The study consists of four parts. Part I is the screening phase, which starts from the moment the participant has signed the informed consent until the start of the preparations of the study. During the screening, participants will be assessed for study eligibility by the study coordinator and contributors. If the participant is eligible, he or she will be randomly assigned into 1 of 5 intervention groups: Group 1: Exercise intervention; Group 2: Protein supplement; Group 3: Exercise intervention + protein supplement; Group 4: Exercise + Protein supplement + omega-3 supplement; Group 5: No intervention. Part II is the preparation phase, in which the participants starts some of the interventions before the start of the study to familiarize patients with e.g. the intake of a protein supplement. All the participants will take an oral vitamin D supplement (800 IU cholecalciferol) from 4 weeks before the start of the intervention if their vitamin D level is above 20 nmol/L. Patients with a vitamin D level < 20 nmol/L will receive repletion therapy. A trial diary will be completed by all participants to record PA, falls and intake of protein/omega3/placebo and vitamin D products. Participants in the exercise intervention (group 1, 3 and 4) will be invited to an information session where the Otago Exercise Program (OEP) will be explained and practiced. With respect to the protein supplementation, participants will receive an individually adapted protein supplement to achieve the recommended total daily intake of 1.5 g protein/kg. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between, before or after meals, based on the subjects' food intake assessed by a food diary. The protein powder is commercially available and consists of 4.5g protein/ 5g powder. The participants in group 2, 3 and 4 will start taking the protein supplement or matched placebo 5 days before the start of the intervention. Four weeks before the start of the intervention, the participants of group 4 will start with the intake of omega-3 (1 capsule providing in total 500 mg eicosapentanoic acid (EPA) and 450 mg docosahexaenoic acid (DHA)) or matched placebo. Placebo will be provided for the participants who are not given a protein and/or omega-3 supplement. Participants are blinded to the nutritional interventions. The third part of the study, the intervention period, takes 12 weeks. During this period, there are 8 contact moments (at baseline, week 1, week 2, week 4, week 6, week 8, week 10 and week 12). All the participants continue with the vitamin D supplementation. Participants in the exercise intervention (group 1, 3 and 4) will perform the optimized and personally adapted OEP and will also follow a walking plan. The strength exercises of the OEP are personalised based on the individual's 1 repetition maximum. Balance exercises of the OEP are personalised based on improvements on MiniBESTest scores during the intervention period. The nutritional intervention groups (protein supplementation: group 2, 3 and 4 and omega-3 supplementation: group 4) continue with the protein and/or omega-3 supplements until the last visit of the intervention period. Part IV is the follow-up period, after the intervention. This phase takes 12 weeks and exists of 2 telephone contacts and 2 contact moments. All the participants continue the vitamin D supplementation until the last visit of the follow-up. The exercise intervention group (group 1, 3 and 4) may continue the OEP, but no personal encouragement will be given during this period. No protein and/ or omega-3 supplements will be given during the follow-up. Several outcomes will be measured during the contact moments of the intervention period and follow-up period (part III and part IV). This will be done by questionnaires about nutritional status, fall history and use of health care (from baseline until end of follow-up), and evaluation of functional and cognitive status. Blood, urine and muscle samples will be taken. The physical activity will be measured by wearing a movement tracker. All participants will wear a movement tracker 5 days before the intervention period and during the first two weeks of the intervention period and last two weeks of the intervention period, and during the last 2 weeks of the follow-up period. Participants who receive an exercise intervention (group 1, 3 and 4) will be encouraged to wear the movement tracker during the complete intervention period. The participants will complete a four-day food diary throughout the trial at week 1, week 6, week 12 and week 24. The participants will be asked for compliance during the preparation period and intervention period and their fall history which can be monitored by using diaries during the intervention period and the follow-up period. Addendum 27-07-2021: starting from 01-2021 a substudy was initiated in which participants of ENHANce, who agreed for participation in this substudy, collect stool samples at baseline, week 4, week 8 and week 12 of the intervention. This will allow to observe possible changes in gut microbiota composition and intestinal inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Nutrition, Protein, Vitamin D, Exercise, Older people, Frailty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant: Yes blinded for protein and omega-3 Investigator: Yes blinded for protein and omega-3 Outcomes Assessor: Yes blinded for protein and omega-3 No blinding for exercise intervention. Statistician is blinded for protein, omega-3 and exercise intervention.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based training program
Arm Type
Experimental
Arm Description
Home-based training program + protein placebo + omega-3 placebo
Arm Title
High-quality protein supplement
Arm Type
Experimental
Arm Description
High-quality protein supplement + omega-3 placebo
Arm Title
2 Anabolic interventions
Arm Type
Experimental
Arm Description
Home-based training program and high quality protein supplement
Arm Title
3 Anabolic interventions
Arm Type
Experimental
Arm Description
Home-based training program, high-quality protein supplement and omega-3 fatty acids
Arm Title
Placebo protein powder and omega-3
Arm Type
Placebo Comparator
Arm Description
Control group: protein placebo + omega-3 placebo
Intervention Type
Behavioral
Intervention Name(s)
Home-based training program
Intervention Description
Exercise intervention: During the intervention period, the participant will perform the optimized and personally adapted Otago Exercise Program (OEP). The participant is encouraged to perform the resistance exercises three times a week with a rest day in between. The participant is advised to perform the exercises in close temporal proximity to one of the moments of the intake of the protein supplement. The participant will also follow a walking plan in which he or she needs to walk 30 minutes twice a week. These 30 minutes can be broken down to three 10-minute walks throughout the day. During the follow-up period, participants may continue the OEP, but no personal encouragement will be given during this period.
Intervention Type
Dietary Supplement
Intervention Name(s)
High-quality protein supplement
Intervention Description
The participant will receive an individually adapted protein supplement to achieve the recommend total (usual diet and supplements) daily intake of 1.5 g/protein/kg for frail elderly. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between meals, or before breakfast or after dinner, based on the subjects' food intake assessed by a food diary. The participant will take the protein supplement from 5 days before the start of the intervention. The protein powder is commercially available and consists of 4.5g protein/5g powder. During the follow-up, no protein supplement is added.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Intervention Description
Four weeks before the start of the intervention, the participant will start the intake of 1 omega-3 capsule providing in total 500 mg EPA and 450 mg DHA until the end of the intervention. He or she has to take the supplement once daily at a chosen time. During the follow-up, no omega-3 supplement will be given.
Intervention Type
Drug
Intervention Name(s)
Placebo protein powder
Intervention Description
Isocaloric maltodextrin powder. Amount based on food diary.
Intervention Type
Drug
Intervention Name(s)
Placebo omega-3
Intervention Description
Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day
Primary Outcome Measure Information:
Title
Change in physical functioning
Description
Change in SPPB score
Time Frame
Measured at baseline, week 12 and week 24.
Title
Percentage of participants with change in physical functioning
Description
the percentage of participants with more than 1 or 1 point increase in SPPB score.
Time Frame
Measured at baseline, week 12 and week 24.
Secondary Outcome Measure Information:
Title
Change in muscle mass (after intervention-baseline)
Description
Appendicular lean mass will be measured with a whole-body DXA scan and by BIA.
Time Frame
Measured at screening, week 12 and week 24 with DXA or when screening is 6 weeks prior to baseline, DXA will also be performed at baseline. At screening, baseline, week 12 and week 24 with BIA.
Title
Change in muscle strength (after intervention-baseline)
Description
Muscle strength of the knee-extensor, knee-flexor and hip abductors will be measured by Biodex and hand grip strength with dynamometer.
Time Frame
Hand grip measured at screening, baseline, week 12 and week 24. Biodex measured at baseline, week 12 and week 24.
Title
Compliance to the exercise intervention, subjective
Description
Compliance to the Otago program will be assessed by measure of: - The number of Otago sessions the participant performed divided by the number of Otago sessions the participants needed to perform. Likewise, this will be calculated for the walking program and for the integral exercise intervention.
Time Frame
baseline until week 12
Title
Compliance to the exercise intervention, objective
Description
Compliance to the Otago program will be assessed by measure of: - Monitor and diary: Length of exercise session (time). Pattern recognition of exercise groups by algorithm development
Time Frame
baseline until week 12
Title
Compliance to the exercise intervention, subjective, detailed
Description
Compliance to the Otago program will be assessed by measure of: - Diary: the reported intensity of the strength exercises
Time Frame
baseline until week 12
Title
Compliance to the protein supplementation, objective
Description
Compliance to protein supplementation: - The number of nutritional intakes the participant did divided by the number of intakes of nutritional supplement the participant was prescribed.
Time Frame
Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24.
Title
Compliance to the protein supplementation, subjective
Description
Compliance to protein supplementation: - Count and weight returned powder boxes
Time Frame
Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24.
Title
Compliance to the protein supplementation objective
Description
Compliance to protein supplementation: - N content in 8 24h urine samples by the Dumas method (28) to estimate rise in protein intake and Creatinine index to estimate the completion of the urine samples (29, 30)
Time Frame
Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24.
Title
Compliance to the omega-3 supplementation, subjective
Description
Compliance to omega-3 supplement - Count returned capsules and placebo tablets
Time Frame
baseline, week 12 and week 24.
Title
Compliance to the omega-3 supplementation, objective
Description
Compliance to omega-3 supplement - Compliance to the omega- 3 supplement is assessed by counting the number of capsules during each study visit and by analysis of red blood cell (RBC) membrane fatty acid profile
Time Frame
baseline, week 12 and week 24.
Title
Functional status: frailty
Description
- Change in physical frailty stage defined by Fried et al (frail (3-5/5), prefrail (1-2/5), robust (0/5))
Time Frame
baseline, week 12 and 24
Title
Functional status: activities of daily living
Description
Change in activity of daily living (ADL) :Barthel-index
Time Frame
baseline, week 12 and 24
Title
Functional status: balance
Description
Change in balance (Mini-BESTest)
Time Frame
baseline, week 12 and 24
Title
Functional status: change in physical activity
Description
Change in PA by the MoveMonitor+ (MM+) (method under development in our research group)
Time Frame
baseline, week 12 and 24
Title
Functional status: health-related quality of life
Description
- Change in health-related quality of life, according to Short Form Health Survey (SF-36) questionnaire
Time Frame
baseline, week 12 and 24
Title
Functional status: falls
Description
- Number of falls and the circumstances, identified using weekly fall calendars + Falls Efficacy Scale International (FES-I)
Time Frame
baseline, week 12 and 24
Title
Cognitive status: immediate and delayed memory, attention, language and visuospatial skills
Description
- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): immediate and delayed memory, attention, language and visuospatial skills;
Time Frame
baseline, week 12 and 24
Title
Cognitive status: inhibition
Description
Stroop test (inhibition)
Time Frame
baseline, week 12 and 24
Title
Cognitive status
Description
- Maze test
Time Frame
baseline, week 12 and 24
Title
Nutritional status: malnutrition
Description
- Changes in numbers of participants with malnutrition, according to Mini Nutritional Assessment (MNA).
Time Frame
at baseline (preparation for food diary), week 6, week 12 and week 24
Title
Nutritional status: nutrient intake
Description
- Changes in nutrient intake, according to the four day food diary.
Time Frame
at baseline (preparation for food diary), week 6, week 12 and week 24
Title
Patient reported benefits and adverse effects
Description
Benefits and adverse effects are asked. Participants will describe their thoughts about the study, what they like and don't like.
Time Frame
week 1, 4, 8, 12, 16, 20, 22, 24.
Title
Change in C reactive protein (CRP)
Description
change in hs-CRP
Time Frame
baseline, week 1, 4, 12 and 24
Title
Change in hemoglobin
Description
Change in hemoglobin
Time Frame
baseline, week 12 and week 24
Title
Change in creatinine
Description
Change in creatinine
Time Frame
baseline, week 12 and week 24
Title
Change in urea
Description
Change in urea
Time Frame
baseline, week 12 and week 24
Title
Change in serum albumin
Description
Change in serum albumin
Time Frame
baseline, week 12 and week 24
Title
Change in glucose
Description
Change in glucose
Time Frame
baseline, week 12 and week 24
Title
Change in cholesterol (HDL, LDL, total, Triglycerides)
Description
Change in cholesterol (HDL, LDL, total, Triglycerides)
Time Frame
baseline, week 12 and week 24
Title
Change in insulin
Description
Change in insulin
Time Frame
baseline, week 12 and week 24
Title
Change in insulin like growth factor 1 (IGF-1)
Description
Change in IGF-1
Time Frame
baseline, week 12 and week 24
Title
Change in 25-hydroxy-vitamin D
Description
Change in 25-hydroxy-vitamin D
Time Frame
baseline, week 12 and week 24
Title
Change in creatinine kinase
Description
Change in creatinine kinase
Time Frame
baseline, week 12 and week 24
Title
Change in indoxyl sulfate
Description
Change in indoxyl sulfate
Time Frame
baseline, week 12 and week 24
Title
Change in interleukin 6 (IL-6)
Description
Change in IL-6
Time Frame
baseline, week 12 and week 24
Title
Change in IL-1b
Description
Change in IL-1b
Time Frame
baseline, week 12 and week 24
Title
Change in tumor necrosis factor alpha (TNF-alpha)
Description
Change in TNF-alpha
Time Frame
baseline, week 12 and week 24
Title
Change in myostatin
Description
Change in myostatin
Time Frame
baseline, week 12 and week 24
Title
Change in activin A
Description
Change in activin A
Time Frame
baseline, week 12 and week 24
Title
Change in markers of muscle wasting
Description
Change in markers of muscle wasting (MURF1, Atrogin1, FOXO3)
Time Frame
baseline, week 12
Title
Change in markers of muscle regeneration
Description
Change in markers of muscle regeneration (PAX7, Myogenic factor 5 (MYF5), myoblast determination protein (MyoD), Ki67, mammalian target of rapamycin (mTOR), AMPK)
Time Frame
baseline, week 12
Title
Change in muscle histology
Description
Change in muscle histology
Time Frame
baseline, week 12
Title
Change in composition of gut microbiota
Description
Change in composition of gut microbiota
Time Frame
baseline, week 4, week 8, week 12
Title
Change in markers of intestinal inflammation
Description
Change in markers of intestinal inflammation (fecal calprotectin, lactoferrin, S100A12)
Time Frame
baseline, week 4, week 8, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female persons with (pre)sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP): reduced muscle mass without (presarcopenia) or with (sarcopenia) reduced walking speed (≤ 0.8m/s) or muscle strength OR probable, confirmed or severe sarcopenia according to EWGSOP 2. 65 years or older; Community-dwelling elderly or assisted living; In case of one or more positive answer(s) on the health screen for exercise, subjects need approval of their general practitioner to participate in this randomized controlled trial (RCT). Uncontrolled or unstable health problems Uncontrolled pain or feeling unwell the day of the exercise Recently diagnosed cardiovascular events systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg Resting tachycardia > 100 bpm Uncontrolled atrial or ventricular arrhythmias Unstable or acute heart failure Lasting, increased pain following a previous session Suspected acute injury Recent injurious fall without medical assessment Severe breathlessness or dizziness Uncontrolled pulmonary problems Rheumatoid arthritis flare up or acute systemic illness/infection Unexplained lethargy Exclusion Criteria: Impairments/diseases that impose problems to participation in the study; Allergy to milk or soy or peanut; Mini-Mental State Examination (MMSE) < 21; Terminal illness (prognosis < 6 months); Persons who followed a physical training program in the last 6 months (twice or more/week); Persons with a daily intake of > 1.5 g protein/kg body weight (BW)/day; Diagnosis of severe kidney disease (GFR < 30 ml/min) or diabetes mellitus; Unable to communicate in Dutch, English or French.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laur Vercauteren, MSc
Phone
+32 16 34 38 67
Email
laura.vercauteren@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jolan Dupont, MD
Phone
+32 16 34 32 01
Email
jolan.dupont@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelien Gielen, Prof MD PhD
Organizational Affiliation
Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerontology and Geriatrics, Department of Public Health and Primary Care, KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lenore Dedeyne, PhD
Phone
+32 16 34 01 35
Email
Lenore.dedeyne@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Jolan Dupont, MD
Phone
+32 16 34 32 01
Email
jolan.dupont@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Evelien Gielen, Prof MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33302879
Citation
Dedeyne L, Dupont J, Koppo K, Verschueren S, Tournoy J, Gielen E. Exercise and Nutrition for Healthy AgeiNg (ENHANce) project - effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial. BMC Geriatr. 2020 Dec 10;20(1):532. doi: 10.1186/s12877-020-01900-5.
Results Reference
derived

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Exercise and Nutrition for Healthy AgeiNg

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