NCT05309057

Brief Summary

Intermittent fasting is a method of restricting calories over a defined period of time and includes regimens such as whole-day fasting, alternate-day fasting, and time-restricted feeding. There is emerging evidence that intermittent fasting or energy restriction might be more beneficial than continuous energy restriction for some risk factors. The effect of intermittent fasting on risk factors associated with obesity, diabetes, and cardiovascular disease, however, is not clear. The European Association for the Study of Diabetes (EASD) has yet to make any recommendations regarding the role of intermittent fasting in the management of diabetes. To inform the update of the EASD Clinical Practice Guidelines for Nutrition Therapy, tthe Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned a systematic review and network meta-analysis of randomized controlled trials of the effect of different intermittent fasting strategies on established cardiometabolic risk factors. The findings generated by this proposed knowledge synthesis will shape guide current guidelines and improve health outcomes by educating healthcare providers and patients, and by guiding future research design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

March 16, 2022

Last Update Submit

March 24, 2022

Conditions

Keywords

Intermittent fastingContinuous energy restrictionWeight lossSystematic review and meta-analysisNetwork metanalysisRandomized controlled trialClinical practice guidelineAdiposityGlycemic controlBlood pressureBlood lipidsNAFLD markersUric acidinflammatory markersCardiometabolic risk factors

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Body weight in kg

    Through study completion, up to 20 years

Secondary Outcomes (19)

  • Adiposity - BMI

    Through study completion, up to 20 years

  • Adiposity - Waist circumference

    Through study completion, up to 20 years

  • Adiposity - Body fat

    Through study completion, up to 20 years

  • Glycemic control - HbA1c

    Through study completion, up to 20 years

  • Glycemic control - fasting plasma glucose (FPG)

    Through study completion, up to 20 years

  • +14 more secondary outcomes

Study Arms (1)

Studies with intermittent fasting

Studies with intermittent fasting strategies.

Dietary Supplement: Intermittent Fasting

Interventions

Intermittent FastingDIETARY_SUPPLEMENT

Methods of intermittent fasting strategies, continuous energy restriction, and ad libitum diet.

Studies with intermittent fasting

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults of all health statuses.

You may qualify if:

  • Randomized controlled trials in humans
  • Intermittent fasting intervention
  • Continuous energy restriction, ad libitum diet, or other intermittent fasting diet as comparators
  • Diet duration ≥1 weeks
  • Data for at least one prespecified outcome
  • Viable outcome data

You may not qualify if:

  • Non-human studies
  • Observational studies
  • Children
  • Multi-modal interventions
  • Diet duration \< 1 weeks
  • No viable outcome data
  • Lack of suitable comparator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Faculty of Medicine

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Semnani-Azad Z, Khan TA, Chiavaroli L, Chen V, Bhatt HA, Chen A, Chiang N, Oguntala J, Kabisch S, Lau DC, Wharton S, Sharma AM, Harris L, Leiter LA, Hill JO, Hu FB, Lean ME, Kahleova H, Rahelic D, Salas-Salvado J, Kendall CW, Sievenpiper JL. Intermittent fasting strategies and their effects on body weight and other cardiometabolic risk factors: systematic review and network meta-analysis of randomised clinical trials. BMJ. 2025 Jun 18;389:e082007. doi: 10.1136/bmj-2024-082007.

MeSH Terms

Conditions

ObesityPrediabetic StateDiabetes MellitusHypertensionNon-alcoholic Fatty Liver DiseaseMetabolic SyndromeDyslipidemiasInflammationGoutCardiovascular DiseasesIntermittent FastingWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesFatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismLipid Metabolism DisordersPathologic ProcessesArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFastingFeeding BehaviorBehaviorBody Weight Changes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 4, 2022

Study Start

November 1, 2020

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations