NCT03528317

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

April 24, 2018

Last Update Submit

January 6, 2021

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Measured by digital scale

    Change from baseline to week 24

Secondary Outcomes (8)

  • Triglycerides

    Change from baseline to week 24

  • Glucose

    Change from baseline to week 24

  • Insulin

    Change from baseline to week 24

  • Insulin resistance

    Change from baseline to week 24

  • Sleep quality

    Change from baseline to week 24

  • +3 more secondary outcomes

Study Arms (1)

Alternate day fasting

EXPERIMENTAL

Alternate day fasting with a high protein diet

Other: Alternate day fasting

Interventions

Alternate day fastingOTHER

Alternate day fasting with a high protein diet

Alternate day fasting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 65 years old
  • BMI between 30.0 and 49.9 kg/m2
  • Previously sedentary or lightly active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois, Chicago

Chicago, Illinois, 60622, United States

Location

Related Publications (4)

  • Akasheh RT, Fantuzzi G, Varady KA, Cheng TD, Kalam F. Reduced Serum PD-L1 and Markers of Inflammation in Response to Alternate Day Fasting With a Low-Carbohydrate Intervention: A Secondary Analysis of a Single-Arm Trial. Curr Dev Nutr. 2025 Feb 14;9(3):104566. doi: 10.1016/j.cdnut.2025.104566. eCollection 2025 Mar.

    PMID: 40145019DERIVED

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

  • Kalam F, Gabel K, Cienfuegos S, Wiseman E, Ezpeleta M, Pavlou V, Varady KA. Changes in subjective measures of appetite during 6 months of alternate day fasting with a low carbohydrate diet. Clin Nutr ESPEN. 2021 Feb;41:417-422. doi: 10.1016/j.clnesp.2020.10.007. Epub 2020 Oct 29.

    PMID: 33487299DERIVED

  • Lin S, Lima Oliveira M, Gabel K, Kalam F, Cienfuegos S, Ezpeleta M, Bhutani S, Varady KA. Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):641-649. doi: 10.1016/j.numecd.2020.10.018. Epub 2020 Oct 31.

    PMID: 33358713DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Krista Varady

    University of Illinois Chicago (UIC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 17, 2018

Study Start

June 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)