Insulin ResistancePREFERNCT01769976
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
A study testing Periodic fasting, Energy restriction and Energy balance diet in people with Insulin Resistance, run by University of Adelaide at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Periodic fasting, Energy restriction and Energy balance diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Insulin Resistance
- Being tested
- Periodic fasting, Energy restriction, Energy balance diet
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic fastingOther
Energy restrictionOther
Energy balance dietOther
| Study group | Role | What they receive |
|---|---|---|
| Daily energy restriction | Experimental | 25% reduction in daily energy intake Receives: Other: Energy restriction |
| Energy balance diet | Active comparator | Diet provides 100% of energy requirements and is designed to achieve weight stability Receives: Other: Energy balance diet |
| Periodic fasting with weight loss | Experimental | Fast 3 days per week, and consume 1.5 times usual amount of food on other days Receives: Other: Periodic fasting; Other: Energy restriction |
| Periodic fasting without weight loss | Experimental | Fast 3 days per week, and consume double usual amount of food on other days Receives: Other: Periodic fasting; Other: Energy balance diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
assessed by hyperinsulinemic euglycemic clamp
Measured: 8 weeks
Secondary outcomes (4)
Plasma hormones and adipokines
Measured: 8 weeks
Cognitive function, hunger, and mood
Measured: 8 weeks
Oxidative stress, stress resistance, and lipid metabolism
Measured: 8 weeks
Energy expenditure
resting energy expenditure, and total daily energy expenditure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A/Prof Leonie Heilbronn, University of Adelaide
- Investigators
- Leonie Heilbronn, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769976
- Sponsor's protocol ID
- APP1023401
- Acronym
- PREFER
- Status last verified
- Nov 2015
- First submitted
- 15 Jan 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33512717Hutchison 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.
PubMed 30569640Chen 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.
PubMed 27524654
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
- ClinicalTrials.gov ID
- NCT01769976
- Acronym / sponsor ID
- PREFER / APP1023401
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Daily energy restriction | Experimental | Other: Energy restriction25% reduction in daily energy intake |
| Energy balance diet | Active comparator | Other: Energy balance dietDiet provides 100% of energy requirements and is designed to achieve weight stability |
| Periodic fasting with weight loss | Experimental | Other: Periodic fasting, Other: Energy restrictionFast 3 days per week, and consume 1.5 times usual amount of food on other days |
| Periodic fasting without weight loss | Experimental | Other: Periodic fasting, Other: Energy balance dietFast 3 days per week, and consume double usual amount of food on other days |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodic fasting | Other | Periodic fasting with weight loss, Periodic fasting without weight loss |
| Energy restriction | Other | Daily energy restriction, Periodic fasting with weight loss |
| Energy balance diet | Other | Energy balance diet, Periodic fasting without weight loss |
Primary outcome
Insulin sensitivity
Time frame: 8 weeks
assessed by hyperinsulinemic euglycemic clamp
4 secondary outcomes
Plasma hormones and adipokines
Time frame: 8 weeks
Cognitive function, hunger, and mood
Time frame: 8 weeks
Oxidative stress, stress resistance, and lipid metabolism
Time frame: 8 weeks
Energy expenditure
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 33512717Allaf 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.
- Derived from this study: PubMed 30569640Hutchison 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.
- Derived from this study: PubMed 27524654Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonie Heilbronn principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodic fasting, Energy restriction and Energy balance diet in people with Insulin Resistance, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769976, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.