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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
52
Alternate day fasting with a high protein diet
University of Illinois, Chicago
Chicago, Illinois, United States
Body weight
Measured by digital scale
Time frame: Change from baseline to week 24
Triglycerides
Measured by ELISA
Time frame: Change from baseline to week 24
Glucose
Measured by glucometer
Time frame: Change from baseline to week 24
Insulin
Measured ELISA
Time frame: Change from baseline to week 24
Insulin resistance
Measured as HOMA-IR
Time frame: Change from baseline to week 24
Sleep quality
Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI
Time frame: 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).
Time frame: Change from baseline to week 24
Sleep apnea
Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea
Time frame: Change from baseline to week 24
Appetite
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Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.
Time frame: Change from baseline to week 24