NCT05876260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

May 5, 2023

Last Update Submit

May 6, 2024

Conditions

Overweight and Obesity

Keywords

womenglycemic controlexercise

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycemia

    Postprandial glucose exposure assessed using continuous glucose monitoring

    24 hour post-exercise

Secondary Outcomes (14)

  • 24 hours average glucose

    24 hours post-exercise

  • Nocturnal glucose

    6-8 hours

  • Nocturnal glucose

    6-8 hours

  • Glycemic variability

    24 hours

  • Glycemic variability

    24 hours

  • +9 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

Participants will consume greek yogurt following a single session of exercise

Behavioral: Greek yogurtBehavioral: Exercise

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

ACTIVE COMPARATOR

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

Behavioral: Carbohydrate-based study supplementBehavioral: Exercise

Interventions

Greek yogurtBEHAVIORAL

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

High-intensity interval exercise and post-exercise Greek yogurt (HIIE+GY)
Carbohydrate-based study supplementBEHAVIORAL

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

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

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

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jenna Gillen

Toronto, Ontario, M4K 1V2, Canada

Location

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jenna Gillen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 25, 2023

Study Start

May 24, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)