AzTrials
AzTrials

Type 2 DiabetesNCT02633722

Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?

A study testing Lifestyle intervention B and Lifestyle Intervention D in people with Type 2 Diabetes and Insulin Resistance, run by University of Adelaide at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008. Read more about this study

Who is it for?
Ages 30 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes, Insulin Resistance
What is being tested?
Lifestyle intervention B and Lifestyle Intervention D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteAustralia
Study dates
Jan 2016to 30 Jul 2018
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 30 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Waist circumference >102cm
  • BMI >30 kg/m2

Who cannot join

  • Personal history of cardiovascular disease, diabetes, eating disorders
  • use of medications which may affect energy metabolism, gastrointestinal function, body weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs, androgenic medications, metoclopramide, orlistat, diuretic medications
  • use of prescribed glucose-lowering/antidiabetic medication
  • recent weight change in past 3 months,or does not habitually eat breakfast
  • uncontrolled asthma, current fever, upper respiratory infections
  • current intake of > 140g alcohol/week
Show all 11Show fewer
  • current smokers of cigarettes/cigars/marijuana
  • current intake of any illicit substance
  • experience claustrophobia in confined spaces
  • has donated blood within past 3-months
  • unable to comprehend study protocol

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • University of Adelaide

    Adelaide, South Australia

Other trials in Australia

About this study

Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in mice and non-human primates have shown that moderate caloric restriction (CR) increases lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes. Reduced risk of chronic diseases is also observed in humans following CR. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation" and altering the hormonal appetite response. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Intermittent, or time restricted feeding describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This study will examine the effects of fasting for 15h/day and eating for 9-h per day on glycemic control and metabolic health. This study will build on the existing knowledge base in humans as to whether meal timing, rather than caloric restriction per se, is important to provide the stimulus required to improve metabolic health and reduce risk of chronic disease. Moreover, it will examine whether restricting feeding to later in the day is of lesser benefit to health.

Read the detailed description

The timing of meal intakes distributed across the wake cycle may play a role in body weight regulation and metabolic health in humans. However, only a limited number of studies have interrogated this in humans. Epidemiological evidence shows that individuals who report consuming more of their daily energy intake at the evening meal were more overweight, than those who reported consumed more of their energy intake before lunch. Similarly, eating lunch late in the day (after 15:00 hrs) was predictive of poorer weight loss during a 20-week dietary intervention study and individuals randomized to consume more calories at breakfast had greater weight loss versus those randomized to eat more calories at dinner after 12 weeks. Taken together these data suggest that consuming more calories in the morning may be beneficial for weight management.

Randomised controlled cross-over intervention, where lean individuals were instructed either to consume all of their calories required for weight maintenance over a 4 hour period from 1700-2100h, or as 3 meals/d for 8 weeks. Significant reductions in body weight and body fat mass, by 1.4 and 2.1 kg respectively, were noted when following the TRF protocol. Consumption of the evening meal was supervised within the laboratory, to ensure subjects consumed the entire meal. In light of evidence that rats switched from a nibbling diet to 1 meal/d increased gluconeogenesis and free fatty acid flux from fat depots, the authors postulated that the greater weight loss may be associated with changes in metabolism. Despite this small amount of weight loss, fasting blood glucose levels were increased, and TRF resulted in poorer glucose tolerance in response to an oral glucose tolerance test (OGTT). Thus, consuming a single, large "dinner" meal was detrimental for metabolic health, although no differences in insulinemia were noted. It is unclear whether responses may have differed if the food allowance was prescribed at breakfast or lunch times. Just one other study has performed a randomised controlled TRF protocol in humans. In this study, healthy, lean male subjects were allowed to eat ad libitum for 13h per day (6am-7pm) for 2 weeks. Participants reported eating significantly less on the TRF versus the control condition, and lost -0.4kg compared with a gain of +0.6kg in the control condition. Whilst this is a minor change in body weight, this pattern is not that atypical of modern eating patterns, and further restriction of eating times, and assessment of obese individuals under these conditions is warranted. The metabolic health impacts were not reported in that study.

Several studies in animals have shown that, when fed in the "wrong" phase (i.e. eating when the animal would normally rest) the mice become obese, despite similar energy intake and expenditure, suggesting that the timing of food intake is important in driving the obese phenotype. Moreover, when high-fat energy intake is restricted to the active phase, the animals become obese, but do not develop the metabolic sequelae that are observed when the same foods are provided in the inactive phase. In humans, shift workers are at higher risks of metabolic disorders, including obesity and type 2 diabetes, possibly as a result of clock desynchronization. Alternatively, this may be the result of mis-timing of meals. For example, epidemiological evidence suggests that a shift toward consuming more calories at night is more likely to result in being overweight when compared with breakfast eaters, while eating a greater proportion of calories at the dinner meal is associated with a higher overall intake and an increased risk for obesity, metabolic syndrome and non-alcoholic fatty liver disease. When 10 healthy adults were subjected to a 28 hour "day" during which they consumed 4 isocaloric meals, the resulting circadian misalignment was associated with increased blood glucose, even in the presence of increased insulin. Moreover, in 3 of the subjects, a postprandial glucose response was observed that would suggest a pre-diabetic state. Under these circumstances, it appears that consuming calories at "night" in humans may have deleterious effects on health, and suggests that meal timing may play a key role in mitigating the metabolic impairment that occurs when the circadian rhythm is disrupted. To further confuse the matter, among breakfast skippers, a higher eating frequency (i.e. ≥ 4 eating occasions per day) has been shown to be associated with a higher risk for type 2 diabetes, compared with breakfast eaters who consumed 1-3 meals per day. In light of this evidence, and the apparent beneficial effects of TRF on metabolic health, the importance of the morning meal and its synchronisation with circadian rhythms is unclear.

Screening (S) - Participants will attend the South Australian Health and Medical Research Institute (SAHMRI) and have the research protocol explained to them in detail. Informed consent to participate in the study, including a verbal indication that they understand the general study protocol and requirements is then obtained. Participants will be assessed by a screening questionnaire for diet, medical, and exercise history to determine their eligibility according to the above criteria. Routine clinical checks are then performed (weight, height, waist circumference, blood pressure). If subjects meet eligibility criteria, they will be invited to take part in the study. Participants will have a dual energy x-ray absorptiometry scan and be fitted with a continuous glucose monitor for one week. During this time, participants will also wear an accelerometer and complete diet diaries to complete a baseline assessment of meal intake pattern. Participants will then be randomly assigned to undergo one of two study arms (TRF-b and TRF-d) for one week each. Conditions are separated by a 2-week washout period, during which participants will be encouraged to maintain their usual dietary pattern and physical activity levels.

Metabolic Testing (D0, D7) during each study condition: Participants arrive at 0700 following an overnight fast. Weight and blood pressure is measured following a seated 10 min rest. A 20 G cannula is inserted into an antecubital vein. A fasting blood sample is drawn for lipids, cytokines and glucoregulatory hormones. Resting metabolic rate and whole body nutrient oxidation is measured via indirect calorimetry. A second fasting blood sample is taken immediately prior to a standard test meal at 0800am or 1200pm, depending on study condition and gastric emptying, postprandial glucoregulatory and gut hormone response to re-feeding will be tested for 3 hours. At the first metabolic visit of each study condition, participants will be fitted with the continuous glucose monitor (CGM), and follow their assigned TRF protocol and assessments by CGM will continue for 7 days, before returning for the D7 metabolic visit. Diet records will be taken and accelerometers worn on the upper arm for each period during the study.

Being tested
Lifestyle intervention B, Lifestyle Intervention D
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle intervention BBehavioural

    Time limiting feeding from 8-5pm (TRFb)

  • Lifestyle Intervention DBehavioural

    Time limiting feeding (12-9pm)

Study groups in NCT02633722
Study groupRoleWhat they receive
TRF-bExperimentalParticipants are instructed to eat between 8am-5pm
Receives: Behavioral: Lifestyle intervention B
TRF-dExperimentalParticipants are instructed to eat only between 12-9pm
Receives: Behavioral: Lifestyle Intervention D
BaselineNo interventionNo lifestyle instruction given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprandial glucose response to meal test

    Measured: 3-hours

Secondary outcomes (3)
  1. Postprandial insulin response to test meal

    Measured: 3 hours

  2. Post-prandial gut hormone response to test meal

    Measured: 3 hours

  3. Glycaemic response over 1 week by continuous glucose monitoring

    Measured: 1-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion30 Oct 2016
  4. Study completion30 Jul 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02633722
Sponsor's protocol ID
UAdelaide
Status last verified
Oct 2018
First submitted
15 Dec 2015
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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 33512717
  • Hutchison AT, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.

    PubMed 31002478

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention B and Lifestyle Intervention D in people with Type 2 Diabetes and 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 11 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 11 Oct 2018. 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?

Postprandial glucose response to meal test (time frame: 3-hours). 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 NCT02633722, which also lists 2 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 11 Oct 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in