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Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health (PREFER)

U

University of Adelaide

Status

Completed

Conditions

Insulin Resistance

Treatments

Other: Periodic fasting
Other: Energy balance diet
Other: Energy restriction

Study type

Interventional

Funder types

Other

Identifiers

NCT01769976
APP1023401

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

Female

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

88 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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