ClinicalTrials.gov

History of Changes for Study: NCT03528317
Alternate Day Fasting Combined With a High Protein Background Diet
Latest version (submitted January 6, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 4, 2018 None (earliest Version on record)
2 October 9, 2018 Recruitment Status, Study Status and Study Design
3 April 16, 2019 Study Status
4 January 6, 2020 Recruitment Status, Study Status, Sponsor/Collaborators and Study Design
5 January 6, 2021 Study Status and Outcome Measures
Comparison Format:

Scroll up to access the controls

Study NCT03528317
Submitted Date:  May 4, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2017-1363
Brief Title: Alternate Day Fasting Combined With a High Protein Background Diet
Official Title: Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Enrolling by invitation
Study Start: May 30, 2018
Primary Completion: February 1, 2019 [Anticipated]
Study Completion: February 1, 2019 [Anticipated]
First Submitted: April 24, 2018
First Submitted that
Met QC Criteria:
May 4, 2018
First Posted: May 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 4, 2018
Last Update Posted: May 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Illinois at Chicago
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Obesity
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Alternate day fasting
Alternate day fasting with a high protein diet
Alternate day fasting
Alternate day fasting with a high protein diet
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Krista Varady
Principal Investigator
University of Illinois Chicago (UIC)
Locations: United States, Illinois
University of Illinois, Chicago
Chicago, Illinois, United States, 60622
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services