Clinical trial NCT05876260: Effect of Post-exercise Nutrition on Glycemia in Women
Official title: Influence of Post-exercise Greek Yogurt on 24 h Glycemic Control in Women With Overweight/Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: women
glycemic control
exercise
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Postprandial glycemia
timeFrame: 24 hour post-exercise
Secondary outcomes:
measure: 24 hours average glucose
timeFrame: 24 hours post-exercise
measure: Nocturnal glucose
timeFrame: 6-8 hours
measure: Nocturnal glucose
timeFrame: 6-8 hours
measure: Glycemic variability
timeFrame: 24 hours
measure: Glycemic variability
timeFrame: 24 hours
measure: Glycemic variability
timeFrame: 24 hours
measure: Post-exercise fat oxidation
timeFrame: 1, 2 and 3 hours post-exercise
measure: Fasting glucose concentration
timeFrame: 24 hours post-exercise
measure: Fasting insulin concentration
timeFrame: 24 hours post-exercise
measure: Fasting insulin resistance
timeFrame: 24 hours post-exercise
measure: Bone metabolism
timeFrame: 30, 90, and 180 minutes and 24 hours post-exercise
measure: Bone metabolism
timeFrame: 30, 90, and 180 minutes and 24 hours post-exercise
measure: Bone metabolism
timeFrame: 30, 90, and 180 minutes and 24 hours post-exercise
measure: Bone metabolism
timeFrame: 30, 90, and 180 minutes and 24 hours post-exercise
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Jenna Gillen
state: Ontario
Study officials:
affiliation: University of Toronto
name: Jenna Gillen, PhD
role: PRINCIPAL_INVESTIGATOR
References: