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Completed

NCT Number: NCT05876260

Effect of Post-exercise Nutrition on Glycemia in Women

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jenna Gillen

Toronto, Ontario, M4K 1V2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Greek yogurt

Behavioral

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

Carbohydrate-based study supplement

Behavioral

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

Exercise

Behavioral

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

Primary outcomes

  1. Postprandial glycemia

    Time frame: 24 hour post-exercise

    Postprandial glucose exposure assessed using continuous glucose monitoring

Secondary outcomes

  1. 24 hours average glucose

    Time frame: 24 hours post-exercise

    Average glucose concentration over 24 hours

  2. Nocturnal glucose

    Time frame: 6-8 hours

    Overnight glucose concentration

  3. Nocturnal glucose

    Time frame: 6-8 hours

    Overnight glucose exposure (area under the curve)

  4. Glycemic variability

    Time frame: 24 hours

    Continuous overall net glycemic action (CONGA)

  5. Glycemic variability

    Time frame: 24 hours

    Standard deviation (SD)

  6. Glycemic variability

    Time frame: 24 hours

    Coefficient of variation (%CV)

  7. Post-exercise fat oxidation

    Time frame: 1, 2 and 3 hours post-exercise

    Fat oxidation assessed with indirect calorimetry

  8. Fasting glucose concentration

    Time frame: 24 hours post-exercise

    Venous blood sampling

  9. Fasting insulin concentration

    Time frame: 24 hours post-exercise

    Venous blood sampling

  10. Fasting insulin resistance

    Time frame: 24 hours post-exercise

    Homeostasis Model Assessment (HOMA2)

  11. Bone metabolism

    Time frame: 30, 90, and 180 minutes and 24 hours post-exercise

    Serum concentration of CTX

  12. Bone metabolism

    Time frame: 30, 90, and 180 minutes and 24 hours post-exercise

    Serum concentration of OPG

  13. Bone metabolism

    Time frame: 30, 90, and 180 minutes and 24 hours post-exercise

    Serum concentration of RANKL

  14. Bone metabolism

    Time frame: 30, 90, and 180 minutes and 24 hours post-exercise

    Serum concentration of OC

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Acronym: PEN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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