Overweight and ObesityPENNCT05876260
Effect of Post-exercise Nutrition on Glycemia in Women
A study testing Greek yogurt, Carbohydrate-based study supplement and Exercise in people with Overweight and Obesity, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether post-exercise Greek yogurt following a single session of aerobic exercise improves metabolic and musculoskeletal health in women with overweight/obesity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Greek yogurt, Carbohydrate-based study supplement and Exercise
- 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
- 24 May 2023to 1 May 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 yrs
- BMI ≥27 kg/m2
- Elevated waist circumference (≥88 cm)
- ≤2 structured exercise sessions/week
- Weight stable (within ± 2kg for at least 6 months)
- Experiencing regular natural menstrual cycles
- Non-smoker
Who cannot join
- Allergy to dairy foods
- Diagnosed lactose intolerance or an aversion to foods provided during the study (e.g., post-exercise snacks)
- Previous history of cardiovascular or metabolic disease
- The use of medication for managing blood glucose or lipid metabolism
- Current use of oral contraceptives or use within the last 3 months
- Irregular menstrual cycles (<21 days or >35 days)
Show all 10Show fewer
- Pregnant or lactating
- Recreational tobacco or cannabis use
- Inability to perform the study exercise protocols
- Actively engaging in a low-carbohydrate diet (e.g., ketogenic, Atkins).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Post-exercise Greek Yogurt on 24 h Glycemic Control in Women With Overweight/Obesity
The purpose of this study is to assess whether post-exercise Greek yogurt following a single session of aerobic exercise improves metabolic and musculoskeletal health in women with overweight/obesity.
Read the detailed description
Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires. Participants will undergo baseline testing at our laboratory at the University of Toronto to determine cardiorespiratory fitness, body composition and undergo exercise familiarization.
Eligible participants will be assigned, in a random order, to two metabolic trials approximately 4 weeks apart that involve 4 days of controlled diet and exercise. Each trial takes place over 4 days, but participants are not required to come to the laboratory on all days. The two trials involve: 1) Exercise + Greek Yogurt (GY) 2) Exercise + a carbohydrate-based study supplement (SS).
During the 4 day trials, participants consume controlled diets and the study supplements (GY and SS). On 1 of these days participants will perform exercise in our lab followed by the consumption of GY or SS. Various outcomes will be measured throughout the trial, including glycemic control (via continuous glucose monitoring), fat oxidation, appetite and health outcomes in blood samples.
Throughout the duration of the study, participants will be asked to maintain their habitual diet and physical activity patterns, and maintain their current body weight.
- Conditions
- Overweight and Obesity
- Being tested
- Greek yogurt, Carbohydrate-based study supplement, Exercise
- Keywords
- women, glycemic control, exercise
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greek yogurtBehavioural
Following 2 days of controlled diet, participants will consume greek yogurt following high-intensity interval exercise
Carbohydrate-based study supplementBehavioural
Following 2 days of controlled diet, participants will consume a carbohydrate-based study supplement following high-intensity interval exercise
ExerciseBehavioural
Following 2 days of controlled diet, participants will perform high-intensity interval exercise following an overnight fast
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY) | Experimental | Participants will consume greek yogurt following a single session of exercise Receives: Behavioral: Greek yogurt; Behavioral: Exercise |
| High-intensity interval exercise and post-exercise carbohydrate study supplement (HIIE +SS) | Active comparator | Participants will consume a carbohydrate-based study supplement following a single session of exercise Receives: Behavioral: Carbohydrate-based study supplement; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemia
Postprandial glucose exposure assessed using continuous glucose monitoring
Measured: 24 hour post-exercise
Secondary outcomes (14)
24 hours average glucose
Average glucose concentration over 24 hours
Measured: 24 hours post-exercise
Nocturnal glucose
Overnight glucose concentration
Measured: 6-8 hours
Nocturnal glucose
Overnight glucose exposure (area under the curve)
Measured: 6-8 hours
Glycemic variability
Continuous overall net glycemic action (CONGA)
Measured: 24 hours
Glycemic variability
Standard deviation (SD)
Measured: 24 hours
Glycemic variability
Coefficient of variation (%CV)
Measured: 24 hours
Post-exercise fat oxidation
Fat oxidation assessed with indirect calorimetry
Measured: 1, 2 and 3 hours post-exercise
Fasting glucose concentration
Venous blood sampling
Measured: 24 hours post-exercise
Fasting insulin concentration
Venous blood sampling
Measured: 24 hours post-exercise
Fasting insulin resistance
Homeostasis Model Assessment (HOMA2)
Measured: 24 hours post-exercise
Bone metabolism
Serum concentration of CTX
Measured: 30, 90, and 180 minutes and 24 hours post-exercise
Bone metabolism
Serum concentration of OPG
Measured: 30, 90, and 180 minutes and 24 hours post-exercise
Bone metabolism
Serum concentration of RANKL
Measured: 30, 90, and 180 minutes and 24 hours post-exercise
Bone metabolism
Serum concentration of OC
Measured: 30, 90, and 180 minutes and 24 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start24 May 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Gillen, University of Toronto
- Investigators
- Jenna Gillen, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876260
- Sponsor's protocol ID
- 42756-3
- Acronym
- PEN
- Status last verified
- May 2024
- First submitted
- 5 May 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagnon S, Govette A, Karavetian M, Bailleul C, Klentrou P, Gillen J, Josse A. Acute effects of Greek yogurt consumption on bone status indices following high-intensity interval exercise in premenopausal females with obesity: a secondary analysis from a randomized crossover trial. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-15. doi: 10.1139/apnm-2026-0016.
PubMed 42561457
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Post-exercise Greek Yogurt on 24 h Glycemic Control in Women With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT05876260
- Acronym / sponsor ID
- PEN / 42756-3
- Conditions
- Overweight and Obesity
- Keywords
- women, glycemic control, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 25 May 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 whether post-exercise Greek yogurt following a single session of aerobic exercise improves metabolic and musculoskeletal health in women with overweight/obesity.
Detailed description
Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires. Participants will undergo baseline testing at our laboratory at the University of Toronto to determine cardiorespiratory fitness, body composition and undergo exercise familiarization.
Eligible participants will be assigned, in a random order, to two metabolic trials approximately 4 weeks apart that involve 4 days of controlled diet and exercise. Each trial takes place over 4 days, but participants are not required to come to the laboratory on all days. The two trials involve: 1) Exercise + Greek Yogurt (GY) 2) Exercise + a carbohydrate-based study supplement (SS).
During the 4 day trials, participants consume controlled diets and the study supplements (GY and SS). On 1 of these days participants will perform exercise in our lab followed by the consumption of GY or SS. Various outcomes will be measured throughout the trial, including glycemic control (via continuous glucose monitoring), fat oxidation, appetite and health outcomes in blood samples.
Throughout the duration of the study, participants will be asked to maintain their habitual diet and physical activity patterns, and maintain their current body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY) | Experimental | Behavioral: Greek yogurt, Behavioral: ExerciseParticipants will consume greek yogurt following a single session of exercise |
| High-intensity interval exercise and post-exercise carbohydrate study supplement (HIIE +SS) | Active comparator | Behavioral: Carbohydrate-based study supplement, Behavioral: ExerciseParticipants will consume a carbohydrate-based study supplement following a single session of exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-45 yrs
- BMI ≥27 kg/m2
- Elevated waist circumference (≥88 cm)
- ≤2 structured exercise sessions/week
- Weight stable (within ± 2kg for at least 6 months)
Key exclusion criteria (10 listed)
- Allergy to dairy foods
- Diagnosed lactose intolerance or an aversion to foods provided during the study (e.g., post-exercise snacks)
- Previous history of cardiovascular or metabolic disease
- The use of medication for managing blood glucose or lipid metabolism
- Current use of oral contraceptives or use within the last 3 months
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 |
|---|---|---|
| Greek yogurtFollowing 2 days of controlled diet, participants will consume greek yogurt following high-intensity interval exercise | Behavioural | High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY) |
| Carbohydrate-based study supplementFollowing 2 days of controlled diet, participants will consume a carbohydrate-based study supplement following high-intensity interval exercise | Behavioural | High-intensity interval exercise and post-exercise carbohydrate study supplement (HIIE +SS) |
| ExerciseFollowing 2 days of controlled diet, participants will perform high-intensity interval exercise following an overnight fast | Behavioural | High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY), High-intensity interval exercise and post-exercise carbohydrate study supplement (HIIE +SS) |
Primary outcome
Postprandial glycemia
Time frame: 24 hour post-exercise
Postprandial glucose exposure assessed using continuous glucose monitoring
14 secondary outcomes
24 hours average glucose
Time frame: 24 hours post-exercise
Nocturnal glucose
Time frame: 6-8 hours
Nocturnal glucose
Time frame: 6-8 hours
Glycemic variability
Time frame: 24 hours
Glycemic variability
Time frame: 24 hours
Glycemic variability
Time frame: 24 hours
Post-exercise fat oxidation
Time frame: 1, 2 and 3 hours post-exercise
Fasting glucose concentration
Time frame: 24 hours post-exercise
Fasting insulin concentration
Time frame: 24 hours post-exercise
Fasting insulin resistance
Time frame: 24 hours post-exercise
Bone metabolism
Time frame: 30, 90, and 180 minutes and 24 hours post-exercise
Bone metabolism
Time frame: 30, 90, and 180 minutes and 24 hours post-exercise
Bone metabolism
Time frame: 30, 90, and 180 minutes and 24 hours post-exercise
Bone metabolism
Time frame: 30, 90, and 180 minutes and 24 hours post-exercise
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 7 May 2024.
- Derived from this study: PubMed 42561457Gagnon S, Govette A, Karavetian M, Bailleul C, Klentrou P, Gillen J, Josse A. Acute effects of Greek yogurt consumption on bone status indices following high-intensity interval exercise in premenopausal females with obesity: a secondary analysis from a randomized crossover trial. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-15. doi: 10.1139/apnm-2026-0016.
- 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.
Jenna Gillen, PhD principal investigator
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 Greek yogurt, Carbohydrate-based study supplement and Exercise in people with Overweight and Obesity, 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 7 inclusion and 10 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 7 May 2024. 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?
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?
Postprandial glycemia (time frame: 24 hour post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876260, which also lists 1 linked publication.
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 7 May 2024.