SarcopeniaSaunaNCT05129995
Passive Heat Treatment and Skeletal Muscle Reconditioning Older Adults
A study testing Passive heat treatment in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Passive heat treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65-85 years
- Body mass index 18.5 - 30 kg/m2
- Healthy
- Having given informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
Official title: The Impact of Passive Heat Treatment on Skeletal Muscle Perfusion Capacity and Post-prandial Muscle Protein Synthesis Rates in Healthy Older Adults
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.
Read more
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.
- Conditions
- Sarcopenia
- Being tested
- Passive heat treatment
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive heat treatmentOther
Also called Sauna bathing
Participants will be subjected to an 8-week (3 x pw) passive heat treatment, by means of infrared sauna bathing, intervention.
| Study group | Role | What they receive |
|---|---|---|
| Passive heat treatment | Experimental | Infrared sauna bathing Receives: Other: Passive heat treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial muscle protein synthesis rates
Fractional synthetic rates calculated based on tissue-free, plasma, and protein-bound tracer enrichments using stable isotope methodology
Measured: 4 hours following meal ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start28 Mar 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, within subject study design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129995
- Sponsor's protocol ID
- METC 21-072
- Acronym
- Sauna
- Status last verified
- May 2023
- First submitted
- 10 Nov 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Passive Heat Treatment on Skeletal Muscle Perfusion Capacity and Post-prandial Muscle Protein Synthesis Rates in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT05129995
- Acronym / sponsor ID
- Sauna / METC 21-072
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, within subject study design
| Arm | Type | Receives |
|---|---|---|
| Passive heat treatment | Experimental | Other: Passive heat treatmentInfrared sauna bathing |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65-85 years
- Body mass index 18.5 - 30 kg/m2
- Healthy
- Having given informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive heat treatmentAlso: Sauna bathingParticipants will be subjected to an 8-week (3 x pw) passive heat treatment, by means of infrared sauna bathing, intervention. | Other | Passive heat treatment |
Primary outcome
Post-prandial muscle protein synthesis rates
Time frame: 4 hours following meal ingestion
Fractional synthetic rates calculated based on tissue-free, plasma, and protein-bound tracer enrichments using stable isotope methodology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive heat treatment in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial muscle protein synthesis rates (time frame: 4 hours following meal ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.