Clinical trial NCT01769976: Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Official title: Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 88
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 8 weeks
Secondary outcomes:
measure: Plasma hormones and adipokines
timeFrame: 8 weeks
measure: Cognitive function, hunger, and mood
timeFrame: 8 weeks
measure: Oxidative stress, stress resistance, and lipid metabolism
timeFrame: 8 weeks
measure: Energy expenditure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Leonie Heilbronn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
citation: Hutchison AT, Liu B, Wood RE, Vincent AD, Thompson CH, O'Callaghan NJ, Wittert GA, Heilbronn LK. Effects of Intermittent Versus Continuous Energy Intakes on Insulin Sensitivity and Metabolic Risk in Women with Overweight. Obesity (Silver Spring). 2019 Jan;27(1):50-58. doi: 10.1002/oby.22345.
citation: Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar-Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.