Effect of Post-exercise Nutrition on Glycemia in Women

Overweight and Obesity Clinical Trial

— PEN  

Official title:

Influence of Post-exercise Greek Yogurt on 24 h Glycemic Control in Women With Overweight/Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05876260
• Other study ID #: 42756-3
• Status: Completed
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Greek yogurt
Following 2 days of controlled diet, participants will consume greek yogurt following high-intensity interval exercise
• Carbohydrate-based study supplement
Following 2 days of controlled diet, participants will consume a carbohydrate-based study supplement following high-intensity interval exercise
• Exercise
Following 2 days of controlled diet, participants will perform high-intensity interval exercise following an overnight fast

Locations

Country	Name	City	State
Canada	Jenna Gillen	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemia	Postprandial glucose exposure assessed using continuous glucose monitoring	24 hour post-exercise
Secondary	24 hours average glucose	Average glucose concentration over 24 hours	24 hours post-exercise
Secondary	Nocturnal glucose	Overnight glucose concentration	6-8 hours
Secondary	Nocturnal glucose	Overnight glucose exposure (area under the curve)	6-8 hours
Secondary	Glycemic variability	Continuous overall net glycemic action (CONGA)	24 hours
Secondary	Glycemic variability	Standard deviation (SD)	24 hours
Secondary	Glycemic variability	Coefficient of variation (%CV)	24 hours
Secondary	Post-exercise fat oxidation	Fat oxidation assessed with indirect calorimetry	1, 2 and 3 hours post-exercise
Secondary	Fasting glucose concentration	Venous blood sampling	24 hours post-exercise
Secondary	Fasting insulin concentration	Venous blood sampling	24 hours post-exercise
Secondary	Fasting insulin resistance	Homeostasis Model Assessment (HOMA2)	24 hours post-exercise
Secondary	Bone metabolism	Serum concentration of CTX	30, 90, and 180 minutes and 24 hours post-exercise
Secondary	Bone metabolism	Serum concentration of OPG	30, 90, and 180 minutes and 24 hours post-exercise
Secondary	Bone metabolism	Serum concentration of RANKL	30, 90, and 180 minutes and 24 hours post-exercise
Secondary	Bone metabolism	Serum concentration of OC	30, 90, and 180 minutes and 24 hours post-exercise