Impact of Exercise on the Metabolic Consequences of Overeating

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Overeating Protocol

• Registration Number: NCT02701738
• Lead Sponsor: University of Michigan

Brief Summary

The primary purpose of this study is to examine the effects of 1-week of overeating on important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile, and blood pressure) and factors regulating the structure and metabolic function of fat tissue. This study will determine how regular exercise during this overeating period impacts these responses.

Detailed Description

If subjects are eligible and decide to participate, they will take part in two identical study trials. One is scheduled before and the other is scheduled after 1 week of overeating controlled by the study team. Subjects who exercise regularly will be instructed to exercise the day before their first study trial - and they will be required to exercise during 6 of the 7 days of the overeating period (including the day before their second study trial). Subjects who do not regularly exercise (no planned physical activity) will remain inactive until the completion of both study trials.

Before each study trial If a subject is a regular exerciser, they will be asked to come to the Substrate Metabolism Laboratory in the afternoon before each of the 2 study trials to exercise in the lab for 45 min at a moderate intensity. The evening before the study trial, all subjects will need to eat a standardized dinner meal and snack. They must eat the meal and snack at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.

During each study trial Subjects will arrive at the Substrate Metabolism Laboratory at 7:00AM and will rest quietly for approximately 30 min. After which, the study team will measure their resting blood pressure and their resting metabolic rate. An intravenous catheter (IV) will then be placed in a vein of the subject's hand or forearm for blood sampling. The research team will then collect a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will drink a sweet sugar solution for an Oral Glucose Tolerance Test (OGTT) and the research team will collect blood samples every 15 min for 3 hours. After this 3 hour test, the IV catheter will be removed and subjects will be provided breakfast and discharged.

Study Timeline

• Study Start: 2016-01-12
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-08
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age: 18-40
• Body Mass Index: 20-30 kg/m2
• Exercise group: (≥5 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
• No Exercise group: no regularly planned exercise/physical activity
• Women must have regularly occurring menses and must be premenopausal

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Exclusion Criteria

• Pregnant or lactating
• Blood pressure > 140/90 mm Hg
• Evidence/history of cardiovascular or metabolic disease
• Medications known to affect lipid or glucose metabolism
• Tobacco or electronic cigarette user

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overeating Protocol	Overeating Protocol	Subjects will ingest 30% more calories per day than their calculated daily energy requirements (\~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.

Primary Outcome Measures

Name	Time	Method
Oral Glucose Tolerance	up to 1 week	An index of insulin sensitivity will be measured using the plasma insulin and glucose concentrations during the 3h OGTT

Secondary Outcome Measures

Name	Time	Method
Resting Metabolic Rate	baseline and 1 week
Total Cholesterol	baseline and 1 week	Plasma concentrations of total- cholesterol will be measured
PPARg mRNA expression	baseline and 1 week	cytokine proteins will be measured in adipose tissue

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States