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

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)

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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: Periodic fasting

Other: Energy restriction

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