Alternate Day Fasting Combined With a High Protein Background Diet

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528317
• Other study ID #: 2017-1363
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Alternate day fasting
Alternate day fasting with a high protein diet

Locations

Country	Name	City	State
United States	University of Illinois, Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

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