NCT07692646

Brief Summary

The interventional study will recruit four groups (n=10 per group): Young men and women with normal weight (BMI 18-25), and young men and women with obesity (BMI \>30). The study will investigate the effect of 84 hours of fasting on peak fat oxidation, mitochondrial coupling and the extracellular matrix.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
89mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2033

Study Start

First participant enrolled

June 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 19, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Muscle metabolismMitochondrial couplingExtracellular matrix compositionPeak fat oxidation

Outcome Measures

Primary Outcomes (1)

  • The effect of fasting and obesity on protein glycosylation of the extracellular matrix in adipose tissue

    The composition and protein glycosylation of the extracellular matrix will be measured in abdominal subcutaneous adipose tissue samples in 20 healthy normal weight men and women and 20 healthy obese men and women.

    The fasting will last approximately 84 hours.

Secondary Outcomes (1)

  • The effect of fasting and obesity on peak fat oxidation

    The fasting will last approximately 84 hours

Other Outcomes (1)

  • The effect of fasting and obesity on adipose tissue lipolytic capacity, muscle ketone oxidative capacity and mitochondrial coupling.

    The fasting will last approximately 84 hours.

Study Arms (4)

Young normal weight men

EXPERIMENTAL

BMI \[18, 25\] Age \[18, 40\]

Other: Diet

Young normal weight women

EXPERIMENTAL

BMI \[18, 25\] Age \[18, 40\]

Other: Diet

Young obese men

EXPERIMENTAL

BMI \[30, 40\] Age \[18, 40\]

Other: Diet

Young obese women

EXPERIMENTAL

BMI \[30, 40\] Age \[18, 40\]

Other: Diet

Interventions

DietOTHER

Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.

Young normal weight menYoung normal weight womenYoung obese menYoung obese women

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy normal weight men aged \[18,40\] and BMI \[18,25\]
  • Healthy normal weight women \[18,40\] and BMI \[18,25\]
  • Healthy obese men \[18,40\] and BMI \[30,40\]
  • Healthy obese women \[18,40\] and BMI \[30,40\]

You may not qualify if:

  • Present or former cardiovascular disease and chronical inflammatory disease
  • Consumption of medications and supplements that influence substrate use at rest and/or during exercise
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences

Copenhagen, 2200, Denmark

RECRUITING

MeSH Terms

Conditions

FastingObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Jørn W Helge, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Cross sectional study including four groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2033

Last Updated

July 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

When the experiments are concluded and the paper(s) are accepted that data will be able upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The data will be available after publication and indefinately
Access Criteria
Not known at this state

Locations