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Clinical trialNCT02498002CompletedInterventional

Impacts of Intermittent Fasting on Energy Balance and Associated Health Outcomes

SponsorUniversity of BathEnrollment54ObesityType 2 Diabetes
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Obesity is a global concern with links to conditions such as diabetes. Historically, these conditions have been managed by reducing energy intake on a daily basis, which is often hampered by low adherence rates and compensatory reductions in physical activity. Intermittent fasting (IMF) has become popular as an alternative method of weight loss, where periods of normal eating are punctuated by days of fasting. However, despite its popularity, IMF is scarcely examined within the literature. This study will examine the impact of IMF on energy balance and the associated health outcomes relating to conditions such as diabetes. To achieve this, 36 lean adults and 36 overweight/obese adults will be recruited, excluding those with conditions which may be adversely affected by fasting. Once enrolled, participants will complete a one month control phase, incorporating 12 days of diet and activity monitoring, to ensure their weight is stable before moving in to the intervention phase. The intervention phase will begin with a lab protocol designed to examine body composition, resting metabolic rate and metabolic responses to two successive meals. Once completed, participants will be randomised to one of three diets which are listed below. Comparing the changes seen with diets 1 and 2 will provide the first direct comparison of IMF against more conventional strategies, while diet 3 will allow us to ascertain the role of weight loss in mediating any effects of IMF. 1. Daily calorie restriction - Reduce energy intake by 25% on a daily basis 2. IMF with weight loss - Alternate between 24 hour cycles of fasting and feeding with 150% of normal intake when feeding 3. IMF without weight loss - Alternate between 24 hour cycles of fasting and feeding with 200% of normal intake when feeding All three diets will last for 20 consecutive days, with transitions between each 24 hour diet cycle occurring at 15:00 each day to allow at least one main meal per day. When fasting, participants will only be permitted water and black tea/coffee to eliminate energy intake. Once again physical activity and diet will be monitored for 12 days during the intervention to examine changes in energy expenditure and ensure compliance. Having completed all 20 diet cycles participants will return to the laboratory to repeat the protocol described earlier. Comparing these results against the values seen before the intervention will then allow the effects of IMF to be identified and compared.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • James A Betts, BSc., Ph.D

    Fellow of the American College of Sports Medicine

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United Kingdom
  • University of Bath

    Bath, Somerset, United Kingdom

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 May 2015
Primary completion
4 Sept 2018
Completion
28 Sept 2018
Last update posted
18 Apr 2023
Registered enrollment
54
Registry id
NCT02498002

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.