Effect of a 4-week Alternate Day Intermittent Energy Restriction Intervention vs Reduced

NCT05213520 | Completed

• 1 other identifier: IRB2021-1092
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study is an active control randomized controlled trial with a sample size of 30 that will consist of 2 groups, to evaluate the effects of a one-month alternate day intermittent energy restriction (AltER) intervention on body weight, body composition, resting metabolic rate in college students with obesity as compared to a standard reduced calorie diet (RCD). Among the 30 participants, 15 will be randomized into the experimental group that will receive the AltER intervention while the other 15 will be a part of the active control group that will follow a RCD. The study will be conducted at the Texas Tech University Nutrition and Metabolic Health Initiative.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Body Weight

  Change in body weight in pounds.

  4 weeks

• Fat Mass

  Change in fat mass in pounds as measured by body composition assessment.

  4 weeks

• Resting Metabolic Rate

  Change in resting metabolic rate as measured by indirect calorimetry.

  4 week

Study Arms (2)

Alternate Day Intermittent Energy Restriction

EXPERIMENTAL

Participants assigned to this diet will be asked to alternate between full calorie (no restriction) eating days with eating 40% of their daily caloric requirement on the other day. For example, if their requirement is 2000 calories they would eat 800 calories one day and as much as you want on the other day and repeat every two days. There will be occasional exceptions allowed with maximum of two 40% days in a row (followed by two full days) based on personal schedule with prior approval. They will follow this for 4 weeks.

Other: Alternate Day Intermittent Energy Restriction

Reduced Calorie Diet

ACTIVE COMPARATOR

Participants assigned to this diet will be asked to restrict calorie intake by 500-1000 calories below their daily energy requirement every day. They will follow this for 4 weeks.

Other: Reduced Calorie Diet

Interventions

Alternate Day Intermittent Energy Restriction OTHER

It is a dietary intervention designed to alternate between full energy consumption on one day and 40% of daily energy requirement on the following day.

Alternate Day Intermittent Energy Restriction

Reduced Calorie Diet OTHER

It is a dietary intervention designed to reduce daily calorie intake by 500-1000 kcal below an individual's daily calorie needs.

Reduced Calorie Diet

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 -25 years
• Enrolled as full-time college students
• Have a BMI ≥ 30
• Willing and able to give informed consent
• Willing to follow either dietary intervention assigned to them upon randomization.
• Able to come in for all assessment visits.

You may not qualify if:

• Participants who are currently diagnosed with diabetes mellitus, cardiovascular disease, liver or kidney disease, cancer
• Current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression
• Current suicidal ideation, and recent or past suicide attempts
• History of psychiatric hospitalization (past year).
• History of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
• History of diagnosed substance abuse or alcohol abuse.
• Currently on any weight loss diet.
• Having lost in the past 3 months 10% or more of body weight.
• Unwilling or unable to give informed consent.

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (2)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Nutrition and Metabolic Health Initiative

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin Binks, Ph.D.

  Texas Tech University- Department of Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 30 participants will be randomized into 1 of 2 groups 1) n=15 the experimental group that will receive the alternate day intermittent energy restriction intervention and 2 n=15 will be active control group that will follow a standard reduced calorie diet.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 28, 2022
• Study Start: January 13, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: May 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)