Inactivity, PhysicalNCT05810272
Impact of Postprandial 'Exercise Snacks' on Protein and Glucose Metabolism Following a Period of Step Reduction in Older Adults
A study testing Metabolic Trial and 15 sit-to-stands with calf raises in people with Inactivity, Physical and Aging, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to assess the impact of 3-days reduced physical activity (<1500 steps/day) with/without 'exercise snacks' (15 chair stands with calf raises every 30 min) on skeletal muscle metabolic health. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity, Physical, Aging, Healthy Aging
- What is being tested?
- Metabolic Trial and 15 sit-to-stands with calf raises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2023to 1 Aug 2024
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy older (age: 60-80 y) adults
- BMI between normal to overweight (18.5-29.9 kg/m2)
Who cannot join
- Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
- Alcohol consumption during the study period
- Use of anticoagulants
- Use of a walker, cane, or assistive walking device
- Current or recently remised cancer
- Infectious or gastrointestinal disease
Show all 11Show fewer
- Inability to comply with study protocol (e.g., >1,500 steps/day during Step-Reduction Phase)
- Regular tobacco use
- Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
- Diagnosed chronic illness (e.g. type 2 diabetes, heart disease, thyroid disease)
- Hormonal Replacement Therapy
Trial locations and contacts
1 site in 1 country.
Matthew J Lees, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Goldring Center for High Performance Sport
Toronto, Ontario, M5S 2C9
Matthew J Lees, PhD, 416-946-0400, matthew.lees@utoronto.ca
Hugo JW Fung, PhD (c), hugojernwai.fung@utoronto.ca
About this study
Official title: The Impact of Postprandial 'Exercise Snacks' on Protein and Glucose Metabolism Following a Period of Step Reduction in Older Adults
The purpose of this study is to assess the impact of 3-days reduced physical activity (<1500 steps/day) with/without 'exercise snacks' (15 chair stands with calf raises every 30 min) on skeletal muscle metabolic health.
Read the detailed description
Many adults gradually lose muscle size, strength, and function after the age of 50. These losses are believed to occur faster with periods of reduced activity (e.g., lower step counts or physical movement when sick or injured) and can be difficult to regain by merely returning to a previously normal activity status. Such periods of reduced activity can also impair the body's ability to use the nutrients in the food consumed (e.g., proteins and carbohydrates), which increases the risk of frailty, type 2 diabetes, and ultimately a reduced quality of life. It is important to identify strategies to prevent these losses in muscle size, strength, and function especially during periods of reduced activity.
Recently, our laboratory has found that performing repeated bodyweight chair squats (repeated sit-to-stands with a calf raise) during a single day of reduced activity improves the muscle's ability to use carbohydrates and proteins, which may be a viable strategy to offset the negative effects of step reduction on muscle health.
In this study, the investigators will assess whether completing bodyweight chair squats at regular intervals (i.e., 'exercise snacks') reduces the negative effects of step reduction on carbohydrate and protein metabolism following a meal. The investigators will determine the impact of 'exercise snacks' (15 chair stands with calf raises every 30 min) compared to seated rest on protein and carbohydrate metabolism following three days of step reduction. The investigators will also assess how these responses compare to those seen following three days of normal (i.e., habitual) activity.
- Conditions
- Inactivity, Physical, Aging, Healthy Aging, Sarcopenia, Muscular Atrophy, Neuromuscular Manifestations
- Being tested
- Metabolic Trial, 15 sit-to-stands with calf raises
- Keywords
- Skeletal Muscle, Step-Reduction, Aging, Anabolic Resistance, Physical Activity, Stable Isotopes
- Medical subject headings
- Sedentary Behavior, Sarcopenia, Muscular Atrophy, Neuromuscular Manifestations, Neurologic Manifestations, Nervous System Diseases, Atrophy, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic TrialBehavioural
Participants will undergo a metabolic trial to assess for their anabolic response to a protein-carbohydrate meal.
15 sit-to-stands with calf raisesBehavioural
Also called Exercise Snacks
Participants (n=10; 5F/5M) will be randomized to perform 15 sit-to-stands with calf raises every 30 minutes for the 4 hour duration between muscle biopsies
| Study group | Role | What they receive |
|---|---|---|
| Habitual Activity | Other | Following three days of habitual activity, a metabolic trial will be completed wherein participants (10M/10F) will be assessed for their anabolic response to a protein-carbohydrate meal. Receives: Behavioral: Metabolic Trial |
| Step-Reduction | Experimental | Participants will undergo three days of reduced physical activity (<1,500 steps/day) prior to a metabolic trial to establish their anabolic response to a protein-carbohydrate meal. Receives: Behavioral: Metabolic Trial; Behavioral: 15 sit-to-stands with calf raises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar protein synthesis rates
Myofibrillar protein synthesis rates assessed by incorporation of oral stable isotope tracer in both arms.
Measured: 5 Hours
Secondary outcomes (4)
Whole-body protein turnover
Whole-body protein turnover assessed by oral stable isotope tracers in both arms.
Measured: 5 Hours
Amino acid oxidation and net protein balance
Amino acid oxidation and net protein balance assessed by oral tracers in both arms. Net protein balance is derived from the difference between amino acid intake (known) and total amino acid oxidation over the 5h measurement period.
Measured: 5 Hours
Postprandial insulin area under the curve (AUC) to mixed macronutrient breakfast
The plasma insulin concentration measured by enzyme-linked immunosorbent assay (ELISA) area under the curve (AUC) will be quantified using the trapezoidal rule.
Measured: 5 Hours postprandial
Postprandial glucose area under the curve (AUC) to mixed macronutrient breakfast
The plasma glucose concentration measured by hexokinase method area under the curve (AUC) will be quantified using the trapezoidal rule.
Measured: 5 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inactivity, PhysicalStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel R Moore, PhD, Principal investigator, University of TorontoHugo JW Fung, PhD, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810272
- Sponsor's protocol ID
- ESPEN
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postprandial 'Exercise Snacks' on Protein and Glucose Metabolism Following a Period of Step Reduction in Older Adults
- ClinicalTrials.gov ID
- NCT05810272
- Acronym / sponsor ID
- ESPEN
- Conditions
- Inactivity, Physical, Aging, Healthy Aging, Sarcopenia, Muscular Atrophy, Neuromuscular Manifestations
- Keywords
- Skeletal Muscle, Step-Reduction, Aging, Anabolic Resistance, Physical Activity, Stable Isotopes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Apr 2023 (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.
The purpose of this study is to assess the impact of 3-days reduced physical activity (<1500 steps/day) with/without 'exercise snacks' (15 chair stands with calf raises every 30 min) on skeletal muscle metabolic health.
Detailed description
Many adults gradually lose muscle size, strength, and function after the age of 50. These losses are believed to occur faster with periods of reduced activity (e.g., lower step counts or physical movement when sick or injured) and can be difficult to regain by merely returning to a previously normal activity status. Such periods of reduced activity can also impair the body's ability to use the nutrients in the food consumed (e.g., proteins and carbohydrates), which increases the risk of frailty, type 2 diabetes, and ultimately a reduced quality of life. It is important to identify strategies to prevent these losses in muscle size, strength, and function especially during periods of reduced activity.
Recently, our laboratory has found that performing repeated bodyweight chair squats (repeated sit-to-stands with a calf raise) during a single day of reduced activity improves the muscle's ability to use carbohydrates and proteins, which may be a viable strategy to offset the negative effects of step reduction on muscle health.
In this study, the investigators will assess whether completing bodyweight chair squats at regular intervals (i.e., 'exercise snacks') reduces the negative effects of step reduction on carbohydrate and protein metabolism following a meal. The investigators will determine the impact of 'exercise snacks' (15 chair stands with calf raises every 30 min) compared to seated rest on protein and carbohydrate metabolism following three days of step reduction. The investigators will also assess how these responses compare to those seen following three days of normal (i.e., habitual) activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual Activity | Other | Behavioral: Metabolic TrialFollowing three days of habitual activity, a metabolic trial will be completed wherein participants (10M/10F) will be assessed for their anabolic response to a protein-carbohydrate meal. |
| Step-Reduction | Experimental | Behavioral: Metabolic Trial, Behavioral: 15 sit-to-stands with calf raisesParticipants will undergo three days of reduced physical activity (<1,500 steps/day) prior to a metabolic trial to establish their anabolic response to a protein-carbohydrate meal. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy older (age: 60-80 y) adults
- BMI between normal to overweight (18.5-29.9 kg/m2)
Key exclusion criteria (11 listed)
- Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
- Alcohol consumption during the study period
- Use of anticoagulants
- Use of a walker, cane, or assistive walking device
- Current or recently remised cancer
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 |
|---|---|---|
| Metabolic TrialParticipants will undergo a metabolic trial to assess for their anabolic response to a protein-carbohydrate meal. | Behavioural | Habitual Activity, Step-Reduction |
| 15 sit-to-stands with calf raisesAlso: Exercise SnacksParticipants (n=10; 5F/5M) will be randomized to perform 15 sit-to-stands with calf raises every 30 minutes for the 4 hour duration between muscle biopsies | Behavioural | Step-Reduction |
Primary outcome
Myofibrillar protein synthesis rates
Time frame: 5 Hours
Myofibrillar protein synthesis rates assessed by incorporation of oral stable isotope tracer in both arms.
4 secondary outcomes
Whole-body protein turnover
Time frame: 5 Hours
Amino acid oxidation and net protein balance
Time frame: 5 Hours
Postprandial insulin area under the curve (AUC) to mixed macronutrient breakfast
Time frame: 5 Hours postprandial
Postprandial glucose area under the curve (AUC) to mixed macronutrient breakfast
Time frame: 5 hours postprandial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
Matthew J Lees, PhD contact
Daniel R Moore, PhD principal investigator
University of Toronto
Hugo JW Fung, PhD study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic Trial and 15 sit-to-stands with calf raises in people with Inactivity, Physical and Aging, run by University of Toronto at 1 site in Canada.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Jul 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Moore, PhD (4169464088, dr.moore@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofibrillar protein synthesis rates (time frame: 5 Hours). 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 13 Jul 2023.