Obesity Clinical Trial
Official title:
Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
NCT number | NCT03528317 |
Other study ID # | 2017-1363 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | March 1, 2019 |
Verified date | January 2021 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).
Status | Completed |
Enrollment | 52 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age between 18 to 65 years old - BMI between 30.0 and 49.9 kg/m2 - Previously sedentary or lightly active Exclusion Criteria: - Diabetic - History of binge eating disorder - Taking weight loss-inducing medications - Not weight stable for 3 months prior to the study (weight gain or loss > 4 kg) - Perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days) - Pregnant or trying to become pregnant - Night shift worker - Smokers |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois, Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | Measured by digital scale | Change from baseline to week 24 | |
Secondary | Triglycerides | Measured by ELISA | Change from baseline to week 24 | |
Secondary | Glucose | Measured by glucometer | Change from baseline to week 24 | |
Secondary | Insulin | Measured ELISA | Change from baseline to week 24 | |
Secondary | Insulin resistance | Measured as HOMA-IR | Change from baseline to week 24 | |
Secondary | Sleep quality | Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI | Change from baseline to week 24 | |
Secondary | Insomnia severity | Measured by Insomnia Severity Index (ISI), total score of 0-28. The total score for the ISI is interpreted as follows: no clinically significant insomnia (0-7), sub-threshold insomnia (8-14), moderate severity insomnia (15-21), and severe insomnia (22-28). | Change from baseline to week 24 | |
Secondary | Sleep apnea | Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea | Change from baseline to week 24 | |
Secondary | Appetite | Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite. | Change from baseline to week 24 |
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