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Effect of Post-exercise Nutrition on Glycemia in Women (PEN)

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Greek yogurt
Carbohydrate-based study supplement
Exercise
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring women, glycemic control, exercise

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Jenna GillenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY)

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

Arm Description

Participants will consume greek yogurt following a single session of exercise

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

Outcomes

Primary Outcome Measures

Postprandial glycemia
Postprandial glucose exposure assessed using continuous glucose monitoring

Secondary Outcome Measures

24 hours average glucose
Average glucose concentration over 24 hours
Nocturnal glucose
Overnight glucose concentration
Nocturnal glucose
Overnight glucose exposure (area under the curve)
Glycemic variability
Continuous overall net glycemic action (CONGA)
Glycemic variability
Standard deviation (SD)
Glycemic variability
Coefficient of variation (%CV)
Post-exercise fat oxidation
Fat oxidation assessed with indirect calorimetry
Fasting glucose concentration
Venous blood sampling
Fasting insulin concentration
Venous blood sampling
Fasting insulin resistance
Homeostasis Model Assessment (HOMA2)
Bone metabolism
Serum concentration of CTX
Bone metabolism
Serum concentration of OPG
Bone metabolism
Serum concentration of RANKL
Bone metabolism
Serum concentration of OC

Full Information

First Posted
May 5, 2023
Last Updated
May 30, 2023
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05876260
Brief Title
Effect of Post-exercise Nutrition on Glycemia in Women
Acronym
PEN
Official Title
Influence of Post-exercise Greek Yogurt on 24 h Glycemic Control in Women With Overweight/Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
women, glycemic control, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY)
Arm Type
Experimental
Arm Description
Participants will consume greek yogurt following a single session of exercise
Arm Title
High-intensity interval exercise and post-exercise carbohydrate study supplement (HIIE +SS)
Arm Type
Active Comparator
Arm Description
Participants will consume a carbohydrate-based study supplement following a single session of exercise
Intervention Type
Behavioral
Intervention Name(s)
Greek yogurt
Intervention Description
Following 2 days of controlled diet, participants will consume greek yogurt following high-intensity interval exercise
Intervention Type
Behavioral
Intervention Name(s)
Carbohydrate-based study supplement
Intervention Description
Following 2 days of controlled diet, participants will consume a carbohydrate-based study supplement following high-intensity interval exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Following 2 days of controlled diet, participants will perform high-intensity interval exercise following an overnight fast
Primary Outcome Measure Information:
Title
Postprandial glycemia
Description
Postprandial glucose exposure assessed using continuous glucose monitoring
Time Frame
24 hour post-exercise
Secondary Outcome Measure Information:
Title
24 hours average glucose
Description
Average glucose concentration over 24 hours
Time Frame
24 hours post-exercise
Title
Nocturnal glucose
Description
Overnight glucose concentration
Time Frame
6-8 hours
Title
Nocturnal glucose
Description
Overnight glucose exposure (area under the curve)
Time Frame
6-8 hours
Title
Glycemic variability
Description
Continuous overall net glycemic action (CONGA)
Time Frame
24 hours
Title
Glycemic variability
Description
Standard deviation (SD)
Time Frame
24 hours
Title
Glycemic variability
Description
Coefficient of variation (%CV)
Time Frame
24 hours
Title
Post-exercise fat oxidation
Description
Fat oxidation assessed with indirect calorimetry
Time Frame
1, 2 and 3 hours post-exercise
Title
Fasting glucose concentration
Description
Venous blood sampling
Time Frame
24 hours post-exercise
Title
Fasting insulin concentration
Description
Venous blood sampling
Time Frame
24 hours post-exercise
Title
Fasting insulin resistance
Description
Homeostasis Model Assessment (HOMA2)
Time Frame
24 hours post-exercise
Title
Bone metabolism
Description
Serum concentration of CTX
Time Frame
30, 90, and 180 minutes and 24 hours post-exercise
Title
Bone metabolism
Description
Serum concentration of OPG
Time Frame
30, 90, and 180 minutes and 24 hours post-exercise
Title
Bone metabolism
Description
Serum concentration of RANKL
Time Frame
30, 90, and 180 minutes and 24 hours post-exercise
Title
Bone metabolism
Description
Serum concentration of OC
Time Frame
30, 90, and 180 minutes and 24 hours post-exercise

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Gillen, PhD
Phone
14169783244
Email
jenna.gillen@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Gillen, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jenna Gillen
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4K 1V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Gillen
Email
jenna.gillen@utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Post-exercise Nutrition on Glycemia in Women

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