Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This pilot study proposes to investigate the scope and benefits of a novel, hybrid alternate day fasting protocol tailored to the college student lifestyle. This protocol - Alternate Day Intermittent Energy Restriction (AltER) is novel because it proposes to modify the standard ADF regime by increasing energy intake to 40% of calorie needs on fasting days. While this may not be as restrictive as other protocols, it still can help create a significant energy deficit. Additionally, it will provide flexibility by allowing for two consecutive fast days if the individual chooses to. While most dietary interventions can achieve significant weight loss in this short duration we expect that this approach tailored to college lifestyle will be superior to typical dietary restriction. Subjects will be asked to attend two approximately 90-minute assessment visits (4 weeks apart) at the NMHI facility They will have their height weight and blood pressure measured, fill out questionnaires (attached), and have body composition (BodPod) and resting metabolic rate (Metabolic Cart) measured. At completion of visit one they are randomly assigned to one of two Diet protocols designed to reduce calories and help them to safely lose weight They will also be asked to respond to a brief (3 questions) email survey weekly. The AltER diet alternate between full calorie (no restriction) eating days with eating 40% of your daily caloric requirement on the other day. 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 PI approval. The RCD will require a reduction of 500-1000 calories below daily energy requirement. The intervention or control diet will be followed for a duration of 4 weeks at the end of which the participants will come in for visit 2 which will follow a similar format like visit 1. General Aim To determine the effect of a novel, alternate day intermittent calorie restriction intervention on body weight, fat mass and resting metabolic rate of college students with obesity as compared to a standard reduced calorie diet 3.2.1. Specific Aim 1: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on body weight of college students with obesity as compared to a standard reduced calorie diet. 3.2.1. Specific Aim 2: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on fat mass of college students with obesity as compared to a standard reduced calorie diet. 3.2.2. Specific Aim 3: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on resting metabolic rate of college students with obesity as compared to a standard reduced calorie diet. 3.2.2. Specific Aim 4: To explore the relationships of stress, sleep physical activity and weight history/demographic variables in relation to primary outcomes of interest. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05213520
Study type Interventional
Source Texas Tech University
Contact Martin Binks, Ph.D.
Phone 806-834-4434
Email [email protected]
Status Recruiting
Phase N/A
Start date January 13, 2022
Completion date May 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05040971 - Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes Phase 3
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT03714646 - Beta Glucan and Acetate Production N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Active, not recruiting NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3