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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

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
Body weight [ Time Frame: Change from baseline to week 24 ]
Measured by digital scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2021)
  • Triglycerides [ Time Frame: Change from baseline to week 24 ]
    Measured by ELISA
  • Glucose [ Time Frame: Change from baseline to week 24 ]
    Measured by glucometer
  • Insulin [ Time Frame: Change from baseline to week 24 ]
    Measured ELISA
  • Insulin resistance [ Time Frame: Change from baseline to week 24 ]
    Measured as HOMA-IR
  • Sleep quality [ Time Frame: Change from baseline to week 24 ]
    Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI
  • 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).
  • Sleep apnea [ Time Frame: Change from baseline to week 24 ]
    Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea
  • Appetite [ Time Frame: Change from baseline to week 24 ]
    Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Triglycerides [ Time Frame: Change from baseline to week 24 ]
    Measured by ELISA
  • Glucose [ Time Frame: Change from baseline to week 24 ]
    Measured by glucometer
  • Insulin [ Time Frame: Change from baseline to week 24 ]
    Measured ELISA
  • Insulin resistance [ Time Frame: Change from baseline to week 24 ]
    Measured as HOMA-IR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternate Day Fasting Combined With a High Protein Background Diet
Official Title  ICMJE Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Other: Alternate day fasting
Alternate day fasting with a high protein diet
Study Arms  ICMJE Experimental: Alternate day fasting
Alternate day fasting with a high protein diet
Intervention: Other: Alternate day fasting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2020)
52
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
40
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528317
Other Study ID Numbers  ICMJE 2017-1363
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Krista Varady, University of Illinois at Chicago
Original Responsible Party University of Illinois at Chicago
Current Study Sponsor  ICMJE University of Illinois at Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Krista Varady University of Illinois Chicago (UIC)
PRS Account University of Illinois at Chicago
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP