PEN: Effect of Post-exercise Nutrition on Glycemia in Women

Sponsor
University of Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT05876260
Collaborator
(none)
20
1
2
10.3
1.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Greek yogurt
  • Behavioral: Carbohydrate-based study supplement
  • Behavioral: Exercise
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Influence of Post-exercise Greek Yogurt on 24 h Glycemic Control in Women With Overweight/Obesity
Actual Study Start Date :
May 24, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY)

Participants will consume greek yogurt following a single session of exercise

Behavioral: Greek yogurt
Following 2 days of controlled diet, participants will consume greek yogurt following high-intensity interval exercise

Behavioral: Exercise
Following 2 days of controlled diet, participants will perform high-intensity interval exercise following an overnight fast

Active Comparator: High-intensity interval exercise and post-exercise carbohydrate study supplement (HIIE +SS)

Participants will consume a carbohydrate-based study supplement following a single session of exercise

Behavioral: Carbohydrate-based study supplement
Following 2 days of controlled diet, participants will consume a carbohydrate-based study supplement following high-intensity interval exercise

Behavioral: Exercise
Following 2 days of controlled diet, participants will perform high-intensity interval exercise following an overnight fast

Outcome Measures

Primary Outcome Measures

  1. Postprandial glycemia [24 hour post-exercise]

    Postprandial glucose exposure assessed using continuous glucose monitoring

Secondary Outcome Measures

  1. 24 hours average glucose [24 hours post-exercise]

    Average glucose concentration over 24 hours

  2. Nocturnal glucose [6-8 hours]

    Overnight glucose concentration

  3. Nocturnal glucose [6-8 hours]

    Overnight glucose exposure (area under the curve)

  4. Glycemic variability [24 hours]

    Continuous overall net glycemic action (CONGA)

  5. Glycemic variability [24 hours]

    Standard deviation (SD)

  6. Glycemic variability [24 hours]

    Coefficient of variation (%CV)

  7. Post-exercise fat oxidation [1, 2 and 3 hours post-exercise]

    Fat oxidation assessed with indirect calorimetry

  8. Fasting glucose concentration [24 hours post-exercise]

    Venous blood sampling

  9. Fasting insulin concentration [24 hours post-exercise]

    Venous blood sampling

  10. Fasting insulin resistance [24 hours post-exercise]

    Homeostasis Model Assessment (HOMA2)

  11. Bone metabolism [30, 90, and 180 minutes and 24 hours post-exercise]

    Serum concentration of CTX

  12. Bone metabolism [30, 90, and 180 minutes and 24 hours post-exercise]

    Serum concentration of OPG

  13. Bone metabolism [30, 90, and 180 minutes and 24 hours post-exercise]

    Serum concentration of RANKL

  14. Bone metabolism [30, 90, and 180 minutes and 24 hours post-exercise]

    Serum concentration of OC

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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)

  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jenna Gillen Toronto Ontario Canada M4K 1V2

Sponsors and Collaborators

  • University of Toronto

Investigators

  • Principal Investigator: Jenna Gillen, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jenna Gillen, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier:
NCT05876260
Other Study ID Numbers:
  • 42756-3
First Posted:
May 25, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jenna Gillen, Assistant Professor, University of Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023