Passive Heat Treatment and Skeletal Muscle Reconditioning Older Adults (Sauna)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Passive heat treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- Aged 65-85 years
- Body mass index 18.5 - 30 kg/m2
- Healthy
- Having given informed consent
Exclusion Criteria:
- Allergy for one of the food items used
- >5% weight change in the previous 6 months
- Participating in a structured (progressive) exercise program, or in the past 3 months.
- Frequent (more than once per week) user of infrared (or traditional) sauna in the past 3 months
- Smoking
- Diagnosed with cardiovascular disease, kidney failure, rheumatoid arthritis
- Diagnosed musculoskeletal, GI tract, metabolic (e.g. diabetes) or pulmonary (e.g. COPD) disorders
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories (NSAIDs).
- Chronic use of gastric acid suppressing medication and/ or anti-coagulants
- Recent (<1 year) participation in amino acid tracer (L-[ring-13C6]-phenylalanine and L-[3,5-2H2]-tyrosine) studies
- Blood donation in the past 2 months
- Strict Following a vegetarian diet
- Known allergic reaction to ultrasound contrast agent
- Non Dutch speaking
Sites / Locations
- Maastricht University Medical Center+
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Passive heat treatment
Arm Description
Infrared sauna bathing
Outcomes
Primary Outcome Measures
Post-prandial muscle protein synthesis rates
Fractional synthetic rates calculated based on tissue-free, plasma, and protein-bound tracer enrichments using stable isotope methodology
Secondary Outcome Measures
Full Information
NCT ID
NCT05129995
First Posted
November 10, 2021
Last Updated
May 3, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Netherlands Organisation for Scientific Research
1. Study Identification
Unique Protocol Identification Number
NCT05129995
Brief Title
Passive Heat Treatment and Skeletal Muscle Reconditioning Older Adults
Acronym
Sauna
Official Title
The Impact of Passive Heat Treatment on Skeletal Muscle Perfusion Capacity and Post-prandial Muscle Protein Synthesis Rates in Healthy Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Netherlands Organisation for Scientific Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rationale: Aging is accompanied by impairments in the sensitivity of skeletal muscle tissue to respond to the anabolic properties of protein feeding, which is suggested to result in age-related loss in muscle mass. Adequate muscle perfusion capacity is essential for muscle mass maintenance, as it determines the rapid delivery of amino acids, nutrients and growth factors to the muscle fiber, thereby stimulating muscle protein synthesis. However, muscle perfusion capacity declines with increasing age. Hence, improving muscle perfusion may be key to augment the sensitivity of senescent muscle following protein feeding in older adults. Although exercise training is an effective way to improve muscle perfusion capacity, there are a number of patient groups that find exercise training difficult to achieve. Hence, alternative strategies need to be developed to improve muscle perfusion capacity. Passive heat treatment (PHT) has been associated with various health benefits in older adult populations, including improved blood pressure, cardiovascular disease risk, and metabolic health. In addition, PHT has been shown to increase muscle fiber capillarization in healthy young adults. However, whether such an intervention improves muscle perfusion capacity, and enhances the anabolic response of skeletal muscle following food ingestion in older adults is unknown.
Objective: To assess the impact of an 8-week passive heat treatment intervention on skeletal muscle fiber capillarization/perfusion capacity and post-prandial muscle protein synthesis rates in healthy older adults.
Study design: single arm, within subject study design
Study population: 14 healthy older (65-85 y) men and women.
Intervention (if applicable): Participants will be subjected to an 8-week (3 x pw) PHT, by means of infrared sauna bathing, intervention. Before and after the PHT intervention the participants will undergo one test day during which blood pressure, body composition, physical function and muscle strength will be assessed. In addition, before and after the PHT intervention period subjects will be complete a 'whole-meal test day' during which the muscle protein synthesis and perfusion capacity response will be evaluated following the ingestion of a whole food meal. Basal and post-prandial muscle protein synthesis and perfusion capacity will be assessed by a continuous infusion of labelled amino acids combined with contrast-enhanced ultrasound measurements. Blood and muscle samples will be collected in order to assess the muscle protein synthetic response.
Main study parameters/endpoints: The primary outcome will be post-prandial muscle protein synthesis rates following meal ingestion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm, within subject study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Passive heat treatment
Arm Type
Experimental
Arm Description
Infrared sauna bathing
Intervention Type
Other
Intervention Name(s)
Passive heat treatment
Other Intervention Name(s)
Sauna bathing
Intervention Description
Participants will be subjected to an 8-week (3 x pw) passive heat treatment, by means of infrared sauna bathing, intervention.
Primary Outcome Measure Information:
Title
Post-prandial muscle protein synthesis rates
Description
Fractional synthetic rates calculated based on tissue-free, plasma, and protein-bound tracer enrichments using stable isotope methodology
Time Frame
4 hours following meal ingestion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 65-85 years
Body mass index 18.5 - 30 kg/m2
Healthy
Having given informed consent
Exclusion Criteria:
Allergy for one of the food items used
>5% weight change in the previous 6 months
Participating in a structured (progressive) exercise program, or in the past 3 months.
Frequent (more than once per week) user of infrared (or traditional) sauna in the past 3 months
Smoking
Diagnosed with cardiovascular disease, kidney failure, rheumatoid arthritis
Diagnosed musculoskeletal, GI tract, metabolic (e.g. diabetes) or pulmonary (e.g. COPD) disorders
Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories (NSAIDs).
Chronic use of gastric acid suppressing medication and/ or anti-coagulants
Recent (<1 year) participation in amino acid tracer (L-[ring-13C6]-phenylalanine and L-[3,5-2H2]-tyrosine) studies
Blood donation in the past 2 months
Strict Following a vegetarian diet
Known allergic reaction to ultrasound contrast agent
Non Dutch speaking
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Passive Heat Treatment and Skeletal Muscle Reconditioning Older Adults
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