The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults

NCT05912348 | Recruiting

• 1 other identifier: UNH-12-FY2023_85-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to learn about the alterations in insulin resistance and metabolic flexibility following a transition to an obesogenic lifestyle in fit young men and women. The main questions it aims to answer are:

1. 1.Does adding excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance and impaired 24hr glucose regulation in healthy men and women?
2. 2.Does adding excess carbohydrates when transitioning to a sedentary lifestyle lower the body's ability to break down fats and carbohydrates in healthy men and women?
3. 3.Does the added physical activity blunt shifts in carbohydrate and fat oxidation in healthy men and women?

Conditions

Insulin Resistance; Impaired Glucose Tolerance; Obesity; Metabolic Disturbance

Outcome Measures

Primary Outcomes (3)

• To determine if low physical activity alone contributes to insulin resistance in healthy, recreationally active young men and women compared to men and women that reduce their physical activity and consume added sugar-sweetened beverages.

  We will use HOMA-IR to measure changes in insulin resistance across the 4 study groups

  10 days

• To determine if the combined low physical activity and added carbohydrates impairs 24-hour glucose regulation compared the other study interventions.

  Compare 24-hour glucose regulation (mmol/L) measurements across the four study groups

  10 days

• To determine if fat oxidation is impaired when participants reduce their physical activity levels and consume added carbohydrates compared to the three interventions

  Compare the change in fat oxidation after the 10 day intervention

  10 days

Study Arms (4)

Low Physical Activity and Added Carbohydrate Group

EXPERIMENTAL

10-days of low physical activity (\~5,000 steps/day) while consuming added sugar-sweetened beverages (\~180 g/day).

Behavioral: Low Physical Activity and Added Carbohydrate Group

Low Physical Activity Control

PLACEBO COMPARATOR

10-days of sedentary activity (\~5,000 steps/day).

Behavioral: Low physical Activity Control

Normal Activity Control

NO INTERVENTION

Maintains normal physical activity levels and exercise training

High Physical Activity and Added Carbohydrate Group

EXPERIMENTAL

10-days of high physical activity (\~11,000 steps/day) while consuming added sugar-sweetened beverages (\~180 g/day).

Behavioral: High Physical Activity and Added Carbohydrate Group

Interventions

Low Physical Activity and Added Carbohydrate Group BEHAVIORAL

Young men and women will transition into a low physically active lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups and one experimental group. One of the control groups will undergo a low physical activity intervention.

Low Physical Activity and Added Carbohydrate Group

Low physical Activity Control BEHAVIORAL

Young men and women will transition into a low physically active lifestyle for 10 days.

Low Physical Activity Control

High Physical Activity and Added Carbohydrate Group BEHAVIORAL

Young men and women will transition into a high physically active lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups and one experimental group.

High Physical Activity and Added Carbohydrate Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Recreationally active completing 75-150 minutes of moderate-to-vigorous intensity exercise (\>2 days/week).
• Fair cardiorespiratory fitness levels (Men: VO2\>38.4 ml/kg/min; Women: VO2\>32.6 ml/kg/min).

You may not qualify if:

• Hypertension (resting or diagnosed)
• Impaired fasting blood glucose (\>100mg/dL)
• Diagnosed cardiovascular disease
• Diagnosed diabetes
• Diagnosed cancer
• Diagnosed chronic kidney disease
• Diagnosed musculoskeletal disorders that prevents the individual from exercising on a bike.

Sponsors & Collaborators

• University of New Hampshire: lead

Study Sites (1)

University of New Hampshire Cardiometabolic Research Laboratory

Durham, New Hampshire, 03824, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael S Brian, PhD

  University of New Hampshire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Brian, PhD

CONTACT

603-714-8899; Michael.Brian@unh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Kinesiology

Model Details: Randomized Cross-Sectional Study Design

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: June 22, 2023
• Study Start: February 8, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (1)