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Alternate Day Fasting Combined With a High Protein Background Diet

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ClinicalTrials.gov Identifier: NCT03528317
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Krista Varady, University of Illinois at Chicago

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Obesity Other: Alternate day fasting Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Alternate day fasting
Alternate day fasting with a high protein diet
 Other: Alternate day fasting
Alternate day fasting with a high protein diet


Outcome Measures
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Primary Outcome Measures :
  1. Body weight [ Time Frame: Change from baseline to week 24 ]
    Measured by digital scale


Secondary Outcome Measures :
  1. Triglycerides [ Time Frame: Change from baseline to week 24 ]
    Measured by ELISA

  2. Glucose [ Time Frame: Change from baseline to week 24 ]
    Measured by glucometer

  3. Insulin [ Time Frame: Change from baseline to week 24 ]
    Measured ELISA

  4. Insulin resistance [ Time Frame: Change from baseline to week 24 ]
    Measured as HOMA-IR

  5. Sleep quality [ Time Frame: Change from baseline to week 24 ]
    Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI

  6. Insomnia severity [ Time Frame: Change from baseline to week 24 ]
    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).

  7. Sleep apnea [ Time Frame: Change from baseline to week 24 ]
    Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea

  8. Appetite [ Time Frame: Change from baseline to week 24 ]
    Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528317


Locations
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United States, Illinois
University of Illinois, Chicago
Chicago, Illinois, United States, 60622
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Krista Varady University of Illinois Chicago (UIC)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Krista Varady, Professor of Nutrition, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03528317    
Other Study ID Numbers: 2017-1363
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight