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OpenTrials
Completed

NCT Number: NCT01769976

Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital

Adelaide, South Australia, 5005, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodic fasting

Other

Energy restriction

Other

Energy balance diet

Other

Primary outcomes

  1. Insulin sensitivity

    Time frame: 8 weeks

    assessed by hyperinsulinemic euglycemic clamp

Secondary outcomes

  1. Plasma hormones and adipokines

    Time frame: 8 weeks

  2. Cognitive function, hunger, and mood

    Time frame: 8 weeks

  3. Oxidative stress, stress resistance, and lipid metabolism

    Time frame: 8 weeks

  4. Energy expenditure

    Time frame: 8 weeks

    resting energy expenditure, and total daily energy expenditure

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Acronym: PREFER

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 17, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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