Alternate Day Fasting Combined With a High Protein Background Diet

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Other: Alternate day fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternate day fasting<br>Alternate day fasting with a high protein diet | Other: Alternate day fasting<br>* Alternate day fasting with a high protein diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Measured by digital scale | Change from baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | Measured by ELISA | Change from baseline to week 24 | 
| Glucose | Measured by glucometer | Change from baseline to week 24 | 
| 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 |