Health TrialsbyHealthPanel

Deciphering a Novel and Unique Brown Adipose Tissue Depot in Women

ConditionCardiometabolic Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-22
SponsorUniversidad de Almeria

About this trial

Type of Study: Clinical Trial

Goal: The goal of this clinical trial is to investigate specific brown and beige fat cells in the dorsocervical area of young, lean adult women.

Participant Population/Health Conditions: The study will involve 40 young, lean adult women.

Main Questions: The main questions this study aims to answer are:

* Are there active brown or beige adipocytes in the subcutaneous fat of the dorsocervical area (i.e., iBAT)? * What is the secretory function of these adipocytes? * How do traditional interventions like cold exposure, as well as new approaches like Beta-2 agonist stimulation and exercise, affect the thermogenesis of these fat cells at the cellular and molecular levels?

Participants Will:

Be randomized into one of four groups: thermoneutral exposure, cold exposure, aerobic exercise, or Beta-2 agonist treatment.

Follow their assigned regimen for 4 weeks. Provide tissue samples from the dorsocervical area and abdomen before and after the 4-week intervention.

Undergo analysis of these samples using advanced techniques to understand the presence and activity of brown and beige fat cells.

Comparison Group: Researchers will compare the effects of different interventions (thermoneutral exposure, cold exposure, aerobic exercise, Beta-2 agonist treatment) on the presence and thermogenesis of brown and beige fat cells in the dorsocervical area.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-22 years of age women.

BMI between ≥18 and <25 kg/m2

Are willing to be randomized to either of these 4 groups.

Must be sedentary (i.e., do not perform exercise or go to the gym).

Disqualifiers

Diabetes mellitus (determined based on fasting glucose levels defined by ADA criteria).

Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia).

Any cardiac disease (i.e., ischemic cardiac disease, arrhythmias, severe heart failure).

Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g., beta-blockers, antidepressants, corticosteroids).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thermoneutral condition

    Behavioral

    Participants will be exposed 2 hours/day at 32ºC for 5 days/week

  • Cold condition

    Behavioral

    Participants will be exposed 2 hours/day at 18ºC for 5 days/week

  • Aerobic exercise condition

    Behavioral

    Participants will perform aerobic exercise training 5 days/week at 65% heart rate reserve for 60 minutes each training session

  • Salbutamol

    Drug

    Participants will take salbutamol 12 mg/day. 7 days week

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Thermoneutral conditionPlacebo comparator 1 intervention
Group B: Cold conditionExperimental treatment 1 intervention
Group C: SalbutamolExperimental treatment 1 intervention
Group D: Aerobic exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in UCP1 expression in the dorsocervical area

Investigators will quantify the level UCP1 expression by qPCR in white adipose tissue biopsies obtained before and after the intervention

Time frame
2 years

Secondary outcomes

1

Body composition (BIA, Tanita)

Change in fat percentage (% of fat)

Time frame
2 years
2

Cardiorespiratory fitness test (indirect calorimetry and monarch bike)

Change in VO2max (ml/kg/min)

Time frame
2 years
3

LDL quantification in blood

Change in LDL-C (mg/dL)

Time frame
2 years
4

HDL quantification in blood

Change in HDL-C (mg/dL)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Almeria

Lead sponsor

Leiden University Medical Center

Collaborator

ETH Zurich (Switzerland)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: