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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).
Background: Accumulating evidence suggests that alternate day fasting (ADF) is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk. ADF regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated with a "fast day" where intake is limited to ~600 kcal over 24 h. What has yet to be elucidated is whether consuming a high protein diet (as meal replacements) during ADF is effective for weight loss, weight maintenance, and metabolic disease risk reduction in individuals with obesity.
Objective: 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).
Methods: A 24-week, single-center, longitudinal pilot study will be conducted to test the study objectives. The trial will be divided into 2 consecutive intervention periods: (1) 12-week weight loss period, and (2) 12-week weight maintenance period. Subjects with obesity will participate in an ADF-HP: alternate day fasting-high protein diet: 600 kcal "fast day" alternated with ad libitum "feast day", 35% kcal as protein. ADF-HP subjects will consume the Optifast HP Shake Mix (Nestle) on each day of the trial. Body weight, insulin, glucose, and insulin resistance, will be measured at baseline, week 12, and week 24.
Significance: These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternate day fasting | Experimental | Alternate day fasting with a high protein diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate day fasting | Other | Alternate day fasting with a high protein diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Measured by digital scale | Change from baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | Measured by ELISA | Change from baseline to week 24 |
| Glucose | Measured by glucometer | Change from baseline to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krista Varady | University of Illinois Chicago (UIC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois, Chicago | Chicago | Illinois | 60622 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40145019 | Derived | Akasheh RT, Fantuzzi G, Varady KA, Cheng TD, Kalam F. Reduced Serum PD-L1 and Markers of Inflammation in Response to Alternate Day Fasting With a Low-Carbohydrate Intervention: A Secondary Analysis of a Single-Arm Trial. Curr Dev Nutr. 2025 Feb 14;9(3):104566. doi: 10.1016/j.cdnut.2025.104566. eCollection 2025 Mar. | |
| 33512717 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Insulin | Measured ELISA | Change from baseline to week 24 |
| Insulin resistance | Measured as HOMA-IR | Change from baseline to week 24 |
| Sleep quality | Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI | Change from baseline to week 24 |
| 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 |
| Sleep apnea | Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea | Change from baseline to week 24 |
| Appetite | Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite. | Change from baseline to week 24 |
| Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. |
| 33487299 | Derived | Kalam F, Gabel K, Cienfuegos S, Wiseman E, Ezpeleta M, Pavlou V, Varady KA. Changes in subjective measures of appetite during 6 months of alternate day fasting with a low carbohydrate diet. Clin Nutr ESPEN. 2021 Feb;41:417-422. doi: 10.1016/j.clnesp.2020.10.007. Epub 2020 Oct 29. |
| 33358713 | Derived | Lin S, Lima Oliveira M, Gabel K, Kalam F, Cienfuegos S, Ezpeleta M, Bhutani S, Varady KA. Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):641-649. doi: 10.1016/j.numecd.2020.10.018. Epub 2020 Oct 31. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |