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ObesityNCT02169778

Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction

A study testing Intermittent energy restricted diet and Continuous energy restricted diet in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

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

Official record
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Trial summary

Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Intermittent energy restricted diet and Continuous energy restricted diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteNorway
Study dates
Aug 2013to Dec 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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • adult (18-50 years old)
  • obese healthy volunteers (30<BMI<40 kg/m2)
  • weight stable on the last three months (<2kg), not currently dieting to lose weight and with an inactive lifestyle

Who cannot join

  • history of endocrine/cardiovascular/pulmonary/kidney disease
  • anaemia
  • milk intolerance
  • depression or other psychological disorders
  • eating disorders
  • drug or alcohol abuse within the last two years
Show all 9Show fewer
  • current medication known to affect appetite or induce weight loss
  • a planned surgery during the study period
  • participating in another research study

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Norwegian University of Science and Technology

    Trondheim

Other trials in Norway

About this study

Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss maintenance and increase the risk of relapse. The aim of this project is to compare the effects of intermittent versus continuous energy restriction on the compensatory responses previously described using two low calory diets, with a similar macronutrient distribution. More specifically, this study will analyze, in the short-term, if an intermittent energy restricted diet is associated with less appetite and low reduction in energy expenditure when compared with a continuous energy restricted diet. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.

Conditions
Obesity
Being tested
Intermittent energy restricted diet, Continuous energy restricted diet
Keywords
Weight loss, Intermittent energy restriction, Metabolic compensation, Diet therapy
Medical subject headings
Obesity, Weight Loss

What participants receive

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

  • Intermittent energy restricted dietBehavioural

  • Continuous energy restricted dietBehavioural

Study groups in NCT02169778
Study groupRoleWhat they receive
Intermittent energy restricted dietExperimentalThe intermittent energy restricted group will undergo 3 nonconsecutive days of partial fasting per week. During the 3 days of partial fasting, participants will be asked to consume a very-low calorie diet (VLCD) providing 550kcal/day for women and 650kcal/day for men. The VLCD products provide 110kcal/pack and include a variety of shakes, smoothies and soups. For the feeding days a diet matching energy needs will be prescribed, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. Drinking at least 2.5 liters of non-caloric liquids will be recommended.
Receives: Behavioral: Intermittent energy restricted diet
Continuous energy restricted dietExperimentalThe continuous energy restricted group will be prescribed a low calorie diet (LCD) with 33% energy restriction, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. The diets' macronutrient composition of the two groups will be matched (50% carbohydrates, 20% protein and 30% fat).
Receives: Behavioral: Continuous energy restricted diet

What is being measured

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

  1. Appetite related hormones

    Appetite-related hormones (active Ghrelin, PYY, GLP-1, CCK) will be measured in fasting and every 30 minutes up to 2,5 hours.

    Measured: 12 weeks after the intervention

Secondary outcomes (5)

  1. Resting metabolic rate (RMR)

    RMR measured by indirect calorimetry

    Measured: 12 weeks after the intervention

  2. Exercise efficiency

    Exercise efficiency measured by graded exercise on a bike

    Measured: 12 weeks after the intervention

  3. Body composition

    RMR measured by indirect calorimetry

    Measured: 12 weeks after the intervention

  4. Body composition

    RMR measured by indirect calorimetry

    Measured: At 6 months from baseline

  5. Body composition

    RMR measured by indirect calorimetry

    Measured: At 1 year from baseline

Timeline

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

  1. First posted23 Jun 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2014
  4. Study completionDec 2015

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02169778
Sponsor's protocol ID
2014/754
Status last verified
Apr 2017
First submitted
17 Jun 2014
Last updated
2 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Coutinho SR, Halset EH, Gasbakk S, Rehfeld JF, Kulseng B, Truby H, Martins C. Compensatory mechanisms activated with intermittent energy restriction: A randomized control trial. Clin Nutr. 2018 Jun;37(3):815-823. doi: 10.1016/j.clnu.2017.04.002. Epub 2017 Apr 7.

    PubMed 28446382

  • Castela I, Rodrigues C, Ismael S, Barreiros-Mota I, Morais J, Araujo JR, Marques C, Silvestre MP, Angelo-Dias M, Martins C, Borrego LM, Monteiro R, Coutinho SR, Calhau C, Faria A, Pestana D, Martins C, Teixeira D. Intermittent energy restriction ameliorates adipose tissue-associated inflammation in adults with obesity: A randomised controlled trial. Clin Nutr. 2022 Aug;41(8):1660-1666. doi: 10.1016/j.clnu.2022.06.021. Epub 2022 Jun 18.

    PubMed 35772219

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent energy restricted diet and Continuous energy restricted diet in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

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 3 inclusion and 9 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 May 2017. 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 Norway. 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?

Appetite related hormones (time frame: 12 weeks after the intervention). 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 NCT02169778, 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 May 2017.

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