Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

Insulin Resistance Clinical Trial

— PREFER  

Official title:

Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769976
• Other study ID #: APP1023401
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: November 30, 2015
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• Periodic fasting

• Energy restriction

• Energy balance diet

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	assessed by hyperinsulinemic euglycemic clamp	8 weeks	No
Secondary	Plasma hormones and adipokines		8 weeks	No
Secondary	Cognitive function, hunger, and mood		8 weeks	No
Secondary	Oxidative stress, stress resistance, and lipid metabolism		8 weeks	No
Secondary	Energy expenditure	resting energy expenditure, and total daily energy expenditure	8 weeks	No