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The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults (Vold)

Primary Purpose

Vegan Diet, Sarcopenia, Cardiovascular Health

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vegan diet
Resistance exercise
Omnivorous diet
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vegan Diet

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged ≥65 years old; Community-dwelling; BMI 25-32 kg/m2; Habitual diet contains animal-based food products (i.e. dairy, meat and/or fish) at least 5 days per week; Exclusion Criteria: Following a self-reported entirely vegetarian or vegan diet during the six months prior to the study; Following a prescribed high (≥1.2 g/kg/d) or low protein diet (<0.8 g/kg/d), and/or or taking protein supplements on medical advice, during the month prior to the study; Participating in a structured progressive resistance exercise training program the during three months prior to the study; ≥4 kg of body weight loss during three months before the start of the study; Being diagnosed with one of the following: diabetes mellitus; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer (with the exception of the following types of skin cancer: basal cell carcinoma, squamous cell carcinoma); (very) severe chronic obstructive lung disease (COPD; GOLD stage III or IV); bowel disease. Chronic use of medication that affects muscle function as assessed by the research physician; The use of anticoagulants incompatible for muscle biopsies as assessed by the research physician: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); edoxaban (lixiana); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole; Having a contra-indication to MRI scanning (including, but not limited to): Pacemakers and defibrillators Infraorbital or intraocular metallic fragments Ferromagnetic implants Claustrophobia Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D; Not willing or afraid to give blood, undergo a muscle biopsy or have an MRI scan during the study; Unwilling to eat a self-composed vegan diet or an omnivorous diet with daily consumption of animal-based food sources for 3 months; Unwilling to participate in RE twice a week for 3 months; Currently a research participant in another trial or participated in a clinical trial during one month before the start of the measurement period; Not being able to understand Dutch; Not having a general physician; Working, or having a direct family member that work at the Division of Human Nutrition at Wageningen University during the study. Unwilling to be informed about incidental findings of pathology and approving of reporting this to their general physician.

Sites / Locations

  • Wageningen University and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Vegan group

Vegan group with resistance exercise

Omnivorous group

Arm Description

Outcomes

Primary Outcome Measures

Change in thigh muscle volume
Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention

Secondary Outcome Measures

Body composition
Other body composition indices will also be measured using magnetic resonance imaging before and after the intervention. These indices include: liver fat fraction, thigh muscle fat infiltration, abdominal subcutaneous adipose tissue, visceral fat tissue.
Change in muscle strength
Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.
Muscle fractional synthesis rates
Muscle fractional synthesis rates, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2^H-alanine enrichment in plasma and the mixed muscle-bound 2^H-alanine enrichment.
Change in bone mineral density
Measured using a Dual X-Ray Absorptiometry dual femur scan
Change in fasting bone turnover markers
Serum procollagen type I N-terminal propeptide (P1NP) will be measured for bone formation and C-terminal telopeptide of type I collagen (CTX) for bone resorption.
Change in plasma insulin growth factor 1 levels
Fasting serum insulin-like growth factor 1 (IGF-1)
Change in plasma parathyroid hormone (PTH) levels
Fasting plasma PTH
Change in fasting plasma insulin levels
Fasting plasma insulin
Change in metabolic profile
Fasting plasma levels of multiple metabolites
Change in fasting blood pressure
Fasting systolic and diastolic blood pressure
Change in haemoglobin levels
Fasting plasma haemoglobin levels
Change in vitamin B12 status
Fasting plasma methylmalonic acid levels
Change in vitamin D status
Fasting serum vitamin D levels
Change in gastro-intestinal symptoms
Self-reported gastro-intestinal symptoms using the gastro-intestinal symptom rating scale. The questionnaire includes 15 questions covering 5 common symptom clusters on a 7-point likert scale ranging from no symptoms (minimum) to severe symptoms (maximum). A higher score indicates worse symptoms.
Untargeted gut metabolomics
Untargeted gut metabolomics will be performed on fasting plasma samples
Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)
Fasting plasma hs-CRP
Change in ferritin levels
Fasting plasma ferritin levels
Tryptophan
Tryptophan will be assessed using targeted metabolomics on plasma samples
Tyrosine
Tyrosine will be assessed using targeted metabolomics on plasma samples
Branch-chained amino acids
Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples
Oxidized amino acids
Oxidized amino acids will be assessed using targeted metabolomics on plasma samples
Gut metagenomics
Microbial DNA will be isolated from the feces samples. The taxonomy and function of specific genes will be assessed via metagenomic sequencing on the microbial DNA.

Full Information

First Posted
March 14, 2023
Last Updated
July 4, 2023
Sponsor
Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT05809466
Brief Title
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Acronym
Vold
Official Title
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University

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
Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. This shift is driven by environmental and health factors. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where the age-related reduction in muscle mass and strength is highly prevalent. Adequate dietary intake, specifically protein intake, is a well-known strategy in promoting muscle mass in older adults. Plant-based foods are currently considered to be inferior to animal-based foods in their protein quality, and are therefore considered to be suboptimal for the maintenance of muscle mass at an older age. On the other hand, combining plant-based foods may improve the protein quality and thereby the anabolic properties of a vegan meal. Evidence regarding the anabolic properties of vegan diets in older adults is scarce. As such, the current study aims to assess 1) the effects of a 12-week self-composed vegan diet in comparison to an omnivorous diet on thigh muscle volume (TMV) in community-dwelling older adults and 2) the effect of a 12-week self-composed vegan diet combined with twice-weekly resistance exercise (RE) on TMV in comparison to a self-composed vegan diet without resistance exercise in community-dwelling older adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegan Diet, Sarcopenia, Cardiovascular Health, Osteoporosis, Gut Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vegan group
Arm Type
Experimental
Arm Title
Vegan group with resistance exercise
Arm Type
Experimental
Arm Title
Omnivorous group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Vegan diet
Intervention Description
A self-composed 12 week fully plant-based diet
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
Biweekly resistance exercise for 12 weeks
Intervention Type
Other
Intervention Name(s)
Omnivorous diet
Intervention Description
Habitual diet containing both animal- and plant-based food products
Primary Outcome Measure Information:
Title
Change in thigh muscle volume
Description
Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Other body composition indices will also be measured using magnetic resonance imaging before and after the intervention. These indices include: liver fat fraction, thigh muscle fat infiltration, abdominal subcutaneous adipose tissue, visceral fat tissue.
Time Frame
Change after 12 weeks
Title
Change in muscle strength
Description
Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.
Time Frame
Change after 12 weeks
Title
Muscle fractional synthesis rates
Description
Muscle fractional synthesis rates, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2^H-alanine enrichment in plasma and the mixed muscle-bound 2^H-alanine enrichment.
Time Frame
10 days
Title
Change in bone mineral density
Description
Measured using a Dual X-Ray Absorptiometry dual femur scan
Time Frame
Change after 12 weeks
Title
Change in fasting bone turnover markers
Description
Serum procollagen type I N-terminal propeptide (P1NP) will be measured for bone formation and C-terminal telopeptide of type I collagen (CTX) for bone resorption.
Time Frame
Change after 6 and 12 weeks
Title
Change in plasma insulin growth factor 1 levels
Description
Fasting serum insulin-like growth factor 1 (IGF-1)
Time Frame
Change after 6 and 12 weeks
Title
Change in plasma parathyroid hormone (PTH) levels
Description
Fasting plasma PTH
Time Frame
Change after 6 and 12 weeks
Title
Change in fasting plasma insulin levels
Description
Fasting plasma insulin
Time Frame
Change after 6 and 12 weeks
Title
Change in metabolic profile
Description
Fasting plasma levels of multiple metabolites
Time Frame
Change after 6 and 12 weeks
Title
Change in fasting blood pressure
Description
Fasting systolic and diastolic blood pressure
Time Frame
Change after 6 and 12 weeks
Title
Change in haemoglobin levels
Description
Fasting plasma haemoglobin levels
Time Frame
Change after 12 weeks
Title
Change in vitamin B12 status
Description
Fasting plasma methylmalonic acid levels
Time Frame
Change after 12 weeks
Title
Change in vitamin D status
Description
Fasting serum vitamin D levels
Time Frame
Change after 12 weeks
Title
Change in gastro-intestinal symptoms
Description
Self-reported gastro-intestinal symptoms using the gastro-intestinal symptom rating scale. The questionnaire includes 15 questions covering 5 common symptom clusters on a 7-point likert scale ranging from no symptoms (minimum) to severe symptoms (maximum). A higher score indicates worse symptoms.
Time Frame
Change after 12 weeks
Title
Untargeted gut metabolomics
Description
Untargeted gut metabolomics will be performed on fasting plasma samples
Time Frame
Change after 12 weeks
Title
Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)
Description
Fasting plasma hs-CRP
Time Frame
Change after 6 and 12 weeks
Title
Change in ferritin levels
Description
Fasting plasma ferritin levels
Time Frame
Change after 12 weeks
Title
Tryptophan
Description
Tryptophan will be assessed using targeted metabolomics on plasma samples
Time Frame
Change after 12 weeks
Title
Tyrosine
Description
Tyrosine will be assessed using targeted metabolomics on plasma samples
Time Frame
Change after 12 weeks
Title
Branch-chained amino acids
Description
Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples
Time Frame
Change after 12 weeks
Title
Oxidized amino acids
Description
Oxidized amino acids will be assessed using targeted metabolomics on plasma samples
Time Frame
Change after 12 weeks
Title
Gut metagenomics
Description
Microbial DNA will be isolated from the feces samples. The taxonomy and function of specific genes will be assessed via metagenomic sequencing on the microbial DNA.
Time Frame
Change after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged ≥65 years old; Community-dwelling; BMI 25-32 kg/m2; Habitual diet contains animal-based food products (i.e. dairy, meat and/or fish) at least 5 days per week; Exclusion Criteria: Following a self-reported entirely vegetarian or vegan diet during the six months prior to the study; Following a prescribed high (≥1.2 g/kg/d) or low protein diet (<0.8 g/kg/d), and/or or taking protein supplements on medical advice, during the month prior to the study; Participating in a structured progressive resistance exercise training program the during three months prior to the study; ≥4 kg of body weight loss during three months before the start of the study; Being diagnosed with one of the following: diabetes mellitus; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer (with the exception of the following types of skin cancer: basal cell carcinoma, squamous cell carcinoma); (very) severe chronic obstructive lung disease (COPD; GOLD stage III or IV); bowel disease. Chronic use of medication that affects muscle function as assessed by the research physician; The use of anticoagulants incompatible for muscle biopsies as assessed by the research physician: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); edoxaban (lixiana); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole; Having a contra-indication to MRI scanning (including, but not limited to): Pacemakers and defibrillators Infraorbital or intraocular metallic fragments Ferromagnetic implants Claustrophobia Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D; Not willing or afraid to give blood, undergo a muscle biopsy or have an MRI scan during the study; Unwilling to eat a self-composed vegan diet or an omnivorous diet with daily consumption of animal-based food sources for 3 months; Unwilling to participate in RE twice a week for 3 months; Currently a research participant in another trial or participated in a clinical trial during one month before the start of the measurement period; Not being able to understand Dutch; Not having a general physician; Working, or having a direct family member that work at the Division of Human Nutrition at Wageningen University during the study. Unwilling to be informed about incidental findings of pathology and approving of reporting this to their general physician.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisette de Groot, PhD
Phone
+31 317 48 80 77
Email
lisette.degroot@wur.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Jacintha Domić, MSc
Email
jacintha.domic@wur.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette de Groot, PhD
Organizational Affiliation
Wageningen University and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University and Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacintha Domic, MSc
Email
jacintha.domic@wur.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults

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