Obesity Clinical Trial
— AltER2022Official title:
Effect of a Novel Alternate Day Intermittent Energy Restriction Intervention vs. Standard Reduced Calorie Diet on Body Weight, Body Composition, and Resting Metabolic Rate in College Students With Obesity
Verified date | November 2022 |
Source | Texas Tech University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | November 5, 2022 |
Est. primary completion date | November 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. Age: 18 -25 years 2. Enrolled as full-time college students 3. Have a BMI = 30 4. Willing and able to give informed consent 5. Willing to follow either dietary intervention assigned to them upon randomization. 6. Able to come in for all assessment visits. Exclusion Criteria: 1. Participants who are currently diagnosed with diabetes mellitus, cardiovascular disease, liver or kidney disease, cancer 2. Current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression 3. Current suicidal ideation, and recent or past suicide attempts 4. History of psychiatric hospitalization (past year). 5. History of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder. 6. History of diagnosed substance abuse or alcohol abuse. 7. Currently on any weight loss diet. 8. Having lost in the past 3 months 10% or more of body weight. 9. Unwilling or unable to give informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Nutrition and Metabolic Health Initiative | Lubbock | Texas |
United States | Texas Tech University - Department of Nutritional Sciences | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Weight | Change in body weight in pounds. | 4 weeks | |
Primary | Fat Mass | Change in fat mass in pounds as measured by body composition assessment. | 4 weeks | |
Primary | Resting Metabolic Rate | Change in resting metabolic rate as measured by indirect calorimetry. | 4 week |
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