NCT00467220

Brief Summary

The purpose of this study is to examine and compare the effects of alternate-day reductions in calorie intake or daily calorie restriction on the risk for cardiovascular disease and cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

April 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2015

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

8.7 years

First QC Date

April 26, 2007

Last Update Submit

January 17, 2020

Conditions

Moderately Overweight Individuals

Keywords

Calorie restrictionalternate day fastingcalorie intake

Outcome Measures

Primary Outcomes (1)

  • Adipose tissue dynamics

    Parameters measured will include adipose tissue dynamics (triglyceride turnover, lipolysis, de novo lipogenesis, adipose cell proliferation), adipose tissue morphology (cell size and number), adipose tissue hormone levels (adiponectin, leptin), skin turnover (keratin dynamics), T-lymphocyte proliferation, as well as plasma lipid and lipoprotein, homocysteine, and C-reactive protein levels.

    12 weeks

Study Arms (3)

Control

NO INTERVENTION

Subjects will follow all study tasks but will not be required to follow a calorie-restricted meal plan.

Alternate Day Fasting Arm

OTHER

Subjects in this arm will be asked to alternate between one day of eating as they wish versus one day on a calorie-restricted meal plan. Subjects will follow this alternating meal plan for 3 months.

Behavioral: calorie restriction

Calorie Restriction

OTHER

Subjects in this arm will be asked to follow a calorie-restricted meal plan, daily, for three months.

Behavioral: calorie restriction

Interventions

calorie restrictionBEHAVIORAL

Subjects in the "calorie restriction" arm and the "alternate day fasting" arm will be asked to follow a menu plan, for three months, that includes some level of calorie restriction.

Alternate Day Fasting ArmCalorie Restriction

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female; body mass index (BMI) between 20-30 kg/m2;
  • Age between 35-65 years; sedentary (light exercise less than 1h per week) or moderately active (1 to 2h per week);
  • Weight stable for \>3 months prior to the beginning of the study;
  • Able to give written informed consent;
  • Female subjects must be post-menopausal for at least 2 years and can not be on hormone replacement therapy (HRT).

You may not qualify if:

  • Diabetic;
  • History of cardiovascular disease, i.e. myocardial infarction or stroke;
  • History of cancer;
  • Taking glucose lowering medication;
  • Taking weight loss medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Marc Hellerstein, MD, PhD

    University of California, Berkeley; University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 30, 2007

Study Start

April 1, 2007

Primary Completion

December 17, 2015

Study Completion

December 17, 2015

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

US(1)