Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Other: Periodic fasting; Other: Energy restriction; Other: Energy balance diet

• Registration Number: NCT01769976
• Lead Sponsor: University of Adelaide

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodic fasting with weight loss	Energy restriction	Fast 3 days per week, and consume 1.5 times usual amount of food on other days
Periodic fasting with weight loss	Periodic fasting	Fast 3 days per week, and consume 1.5 times usual amount of food on other days
Periodic fasting without weight loss	Energy balance diet	Fast 3 days per week, and consume double usual amount of food on other days
Daily energy restriction	Energy restriction	25% reduction in daily energy intake
Energy balance diet	Energy balance diet	Diet provides 100% of energy requirements and is designed to achieve weight stability
Periodic fasting without weight loss	Periodic fasting	Fast 3 days per week, and consume double usual amount of food on other days

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	8 weeks	assessed by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

Name	Time	Method
Cognitive function, hunger, and mood	8 weeks
Plasma hormones and adipokines	8 weeks
Oxidative stress, stress resistance, and lipid metabolism	8 weeks
Energy expenditure	8 weeks	resting energy expenditure, and total daily energy expenditure

Trial Locations

Locations (1)

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia