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NCT Number: NCT07692646

The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location status: Recruiting

Location contact

Jørn W Helge, PhD

CONTACT

[email protected]

+4528757506

About this study

Four groups of young normal weight men (n=10) and women (n=10) and young obese men (n=10) and women (10) are recruited. After verbal and written information is provided signed consent is obtained.

Prior to the first day of the trial, the participants must complete a four-day dietary and exercise record based on the weighing of all food and beverages consumed and tracking all exercise. This is used to asses the participant's habitual diet and activity level. For female participants, an additional form must be completed regarding their menstrual cycle and form of contraception.

On the two trial days (before and after fasting), participants arrive at the laboratory in the morning, and on the first day, the participant will have fasted since the previous evening. Furthermore, participants have been asked to minimize strenous physical activity for 24 hours leading up to testing. Prior to day 1, participants have been instructed to consume a habitual carbohydrate-rich diet for the 48 hours preceding the first test day.

Initially, the participants' body composition is determined by DXA, after which the participants rest for 15 minutes. Subsequently, blood pressure is measured in the supine position whereafter resting energy expenditure is measured by indirect calorimetry. A venous blood sample is taken from the antecubital vein, as well as a biopsy from the m. vastus lateralis and from the subcutaneous abdominal adipose tissue using the Bergström technique applied with suction. After 30 minutes of rest, a graded exercise test on a cycle ergometer is initiated to determine peak fat oxidation and maximal oxygen uptake. After the test is completed and following a minimum of 10 minutes of rest, handgrip strength and knee extension strength are measured. This concludes the test day.

Thereafter, the 84-hour fast is initiated. During the fasting period, the subjects will communicate by telephone each morning with one of the researchers regarding their well-being and any questions they may have. On day 2 subjects will do 1 hour of submaximal exercise. During the fasting subjects will be provided with electrolyte tablets. Following the 84 hours, the subjects return to the laboratory. Here, the same protocol as described above is carried out. This concludes the test day and the experiment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

Exclusion criteria

  • 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

Treatment and study plan

Diet

Other

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.

Primary outcomes

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

    Time frame: The fasting will last approximately 84 hours.

    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.

Secondary outcomes

  1. The effect of fasting and obesity on peak fat oxidation

    Time frame: The fasting will last approximately 84 hours

    40 participants (20 healthy normal weight men and women and 20 healthy obese men and women) will fast for 84 hours. Before and after the fast, peak fat oxidation (mg fat/min) is measured in an incremental bike test using indirect calorimetry.

Other outcomes

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

    Time frame: The fasting will last approximately 84 hours.

    The lipolytic capacity will be measured in abdominal subcutaneous adipose tissue samples and the capacity for ketone oxidation in vastus lateralis muscle in 20 healthy normal weight men and women and 20 healthy obese men and women.and In addition mitochondrial respiratory capacity will be measured in the muscle and adipose biopsy samples using high-resolution respirometry (Oxygraphs, Oroboros).

Study contacts

Contact information is provided by the study sponsor or research team.

Jørn W Helge, PhD

CONTACT

[email protected]

+4528757506

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix in Healthy Men and Lean and Obese Men and Women

Acronym: GlycoFast84

Important dates

Study start
2026
Primary completion
2027
Study completion
2033
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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