NCT01769976

Brief Summary

The aim of this study is to examine whether periodic fasting improves markers of diabetes risk and cardiovascular health, and will compare this to the effects observed with daily dieting by energy restriction, and also with no change in energy intake. It is hypothesized that periodic fasting, with or without weight loss, will be as effective as daily energy restriction to improve markers of metabolic health and energy metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration 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

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

January 15, 2013

Last Update Submit

November 30, 2015

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    assessed by hyperinsulinemic euglycemic clamp

    8 weeks

Secondary Outcomes (4)

  • Plasma hormones and adipokines

    8 weeks

  • Cognitive function, hunger, and mood

    8 weeks

  • Oxidative stress, stress resistance, and lipid metabolism

    8 weeks

  • Energy expenditure

    8 weeks

Study Arms (4)

Daily energy restriction

EXPERIMENTAL

25% reduction in daily energy intake

Other: Energy restriction

Energy balance diet

ACTIVE COMPARATOR

Diet provides 100% of energy requirements and is designed to achieve weight stability

Other: Energy balance diet

Periodic fasting with weight loss

EXPERIMENTAL

Fast 3 days per week, and consume 1.5 times usual amount of food on other days

Other: Periodic fastingOther: Energy restriction

Periodic fasting without weight loss

EXPERIMENTAL

Fast 3 days per week, and consume double usual amount of food on other days

Other: Periodic fastingOther: Energy balance diet

Interventions

Periodic fastingOTHER
Periodic fasting with weight lossPeriodic fasting without weight loss
Energy restrictionOTHER
Daily energy restrictionPeriodic fasting with weight loss
Energy balance dietOTHER
Energy balance dietPeriodic fasting without weight loss

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) between 25 and 42 kg/m2
  • weight stable (\<5% fluctuation in body weight for the 6 months prior to study entry)

You may not qualify if:

  • history of cardiovascular disease, diabetes, major psychiatric disorders, and eating disorders
  • use of prescribed or non-prescribed medications with may affect energy metabolism, gastrointestinal function, body weight, or appetite
  • recent weight changes in 3 months prior to study entry
  • uncontrolled asthma, current fever, upper respiratory infections
  • individuals who regularly perform high intensity exercise (\>2 sessions per week)
  • pregnancy, lactation (breast feeding), women who are planning to become pregnant
  • current intake of \>140g of alcohol per week
  • current smoker of cigarettes/cigars/marijuana
  • current intake of any illicit substance
  • experience claustrophobia in confined spaces
  • has donated blood within the past 3 months
  • unable to comprehend the study protocol
  • experiences migraines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5005, Australia

Location

Related Publications (3)

  • 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

  • Hutchison AT, Liu B, Wood RE, Vincent AD, Thompson CH, O'Callaghan NJ, Wittert GA, Heilbronn LK. Effects of Intermittent Versus Continuous Energy Intakes on Insulin Sensitivity and Metabolic Risk in Women with Overweight. Obesity (Silver Spring). 2019 Jan;27(1):50-58. doi: 10.1002/oby.22345.

    PMID: 30569640DERIVED

  • Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar-Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.

    PMID: 27524654DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Leonie Heilbronn

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

AU(1)