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NCT06878989Fut, nem toboroz

Adaptation of Human Brown Adipose Tissue to Calorie Restriction

Adaptation of Human Brown Adipose Tissue to Calorie Restriction (BATON)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 12.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The BATON study investigates how human brown adipose tissue (BAT) adapts to a controlled caloric restriction diet in young adults with obesity. A weight maintenance diet group will be compared to a group following a diet designed to induce an 8-10% weight loss over a 12-16 week period. Outcome assessments will include advanced technologies such as PET-CT and molecular analyses of BAT. The overarching goal is to gain a deeper understanding of the role of human BAT on the regulation of body weight.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
30 (tervezett)
Első benyújtás
2025. febr. 12.
Kezdés
2025. jan. 25.
Elsődleges befejezés
2026. aug.
Fő szponzor
Universidad de Granada
Betegségek
Elhízás
NCT-szám
NCT06878989

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 30
  • 2025. jan. 25. és az elsődleges befejezés (2026. aug.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Having been exposed to medical procedures involving an estimated radiation dose exceeding 5 mSv in the past 5 years or 10 mSv over a lifetime.
  • Use of medications or supplements that are known to alter body weight or appetite.
  • Active or untreated malignant disease or remission from a clinically significant malignant disease for less than five years prior to the evaluation.

Más betegség

  • Diagnosis or history of metabolic (including any type of diabetes mellitus), hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urologic, or psychiatric diseases that could interfere with study outcomes or protocol adherence.
  • History of any surgical procedure that, in the opinion of the research team, could alter energy metabolism or digestive function during the course of the study.
  • Diagnosis or risk factors for the development of an eating disorder.
  • Clinically significant abnormalities in gastric emptying, current diagnosis of any form of diabetes, blood pressure exceeding 160/90 mmHg, or resting heart rate below 50 or above 100 beats per minute (while seated), regardless of stable antihypertensive medication use.
  • History of drug or alcohol abuse or a positive drug test, unless due to a medication prescribed by a healthcare professional.
  • Any other condition that, in the opinion of the research team, contraindicates study participation.

Egyéb

  • Diagnosis or presence of signs or symptoms that, in the opinion of the research team, may contraindicate the dietary intervention or any of the procedures included in the study.
  • Weight loss exceeding 10% in the past two years or more than 5% in the past six months, unless completed weight recovery has occurred.
  • Adherence to unconventional dietary patterns, such as vegan or fasting diets, or inability to tolerate the foods provided during the study.
  • Pregnancy, plans to become pregnant within the next two years, postpartum period (within 12 months after delivery), or lactation.
  • Perimenopausal status, defined as the presence of irregular menstrual cycles, hormonal changes indicative of perimenopause, or menopausal symptoms.
  • Participation in any type of nutritional intervention or treatment within the past three months.
  • Frequent disruptions in the sleep-wake cycle.
  • Smoking, vaping, or habitual use of tobacco products, unless abstinent for at least 72 consecutive hours during the past four weeks.
  • Habitual caffeine consumption exceeding the equivalent of three espresso coffees per day (225 mg/day).
  • Being a direct relative or household member of the research team personnel.

Kiket keres a vizsgálat

  • Body mass index (BMI) of 27-40 kg/m², with a body fat percentage (determined by DXA, Hologic Wi) exceeding 25% in men and 30% in women.
  • Reported stable body weight over the preceding 3 months (body weight changes of less than 3%).
  • Laboratory safety test results (general biochemistry and complete blood count) within the normal reference range or with abnormalities deemed clinically insignificant by the medical research team and not requiring pharmacological treatment.
  • Adequate venous access for blood sampling required by the procedures described in this protocol and absence of needle, blood, or medical procedure phobia.
  • Readiness and ability to consume all foods included in the assessments and dietary intervention.
  • Ability to understand and comply with study procedures, as assessed by the research team.
  • Availability to participate in the study.
  • Commitment to completing the study regardless of the assigned group.

Életkor a regiszterben: 18 év – 30 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Department of Physiology, Faculty of Medicine, University of Granada.GranadaSpanyolországIsmeretlen állapot

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