- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07692646
The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix (GlycoFast84)
The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix in Healthy Men and Lean and Obese Men and Women
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jørn W Helge, PhD
- Telefonnummer: +4528757506
- E-post: jhelge@sund.ku.dk
Studieorter
-
-
-
Copenhagen, Danmark, 2200
- Rekrytering
- Department of Biomedical Sciences
-
Kontakt:
- Jørn W Helge, PhD
- Telefonnummer: +4528757506
- E-post: jhelge@sund.ku.dk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Young normal weight men
BMI [18, 25] Age [18, 40]
|
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.
|
|
Experimentell: Young normal weight women
BMI [18, 25] Age [18, 40]
|
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.
|
|
Experimentell: Young obese men
BMI [30, 40] Age [18, 40]
|
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.
|
|
Experimentell: Young obese women
BMI [30, 40] Age [18, 40]
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The effect of fasting and obesity on protein glycosylation of the extracellular matrix in adipose tissue
Tidsram: 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.
|
The fasting will last approximately 84 hours.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The effect of fasting and obesity on peak fat oxidation
Tidsram: 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.
|
The fasting will last approximately 84 hours
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The effect of fasting and obesity on adipose tissue lipolytic capacity, muscle ketone oxidative capacity and mitochondrial coupling.
Tidsram: 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).
|
The fasting will last approximately 84 hours.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Molecular Memory of Obesity
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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