Mechanisms of Fasting Induced Reduction in Energy Expenditure

Официальное название

Mechanisms of Fasting Induced Reduction in Energy Expenditure - FIRE Trial

Обзор

Fasting reduces the energy consumption of the human body. The extent of this adaptation varies significantly between different individuals. The aim of this research project is to investigate how this adaptation of the metabolism is regulated by the body. For this purpose, we will first measure how the so-called basal metabolic rate of the body reacts to a short-term fasting of 24 h in a preliminary study. Those subjects with a particularly pronounced and those subjects with an only slightly pronounced reaction of the basal metabolic rate will be invited to the main study. Here, in random order (24 h fasting vs. 8 h fasting), the following is compared * how the basal metabolic rate of the body reacts to the reduced energy intake. * how the energy metabolism increases after a test meal * what role in particular the thyroid hormones play in this adaptation. In addition, a sample of the subcutaneous adipose tissue is taken in each case and it is examined how the regulation of metabolic processes at the cellular level.

Подробное описание

The extent of this adaptation varies significantly between different individuals. The aim of this research project is to investigate how this adaptation of the metabolism is regulated by the body. For this purpose, we will first measure how the so-called basal metabolic rate of the body reacts to a short-term fasting of 24 h in a preliminary study. Those subjects with a particularly pronounced and those subjects with an only slightly pronounced reaction of the basal metabolic rate will be invited to the main study.

Вмешательства

• Другое mixed meal test
  mixed meal test after fasting

Первичные конечные точки

• change of energy expenditure (EE) determined by indirect calorimetry (kcal per 24h) [Срок оценки: 60 minutes after ingestion of test meal]

Вторичные конечные точки (3)

• Level of free thyroxine [Срок оценки: after 24 hours and after 12 hours of fasting]
• Level of free triiodothyronine [Срок оценки: after 24 hours and after 12 hours of fasting]
• Respiratory quotient (RQ) [Срок оценки: after 24 hours and after 12 hours of fasting]

Критерии участия

Критерии включения

• Age: 18 to 40 years
• Body mass index 18.0 to 27.0 kg/m²
• Exclusion Criteria:
• Chronic conditions necessitating medical treatment (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons,
• Hypothyroidism or hyperthyroidism
• Pregnant, breastfeeding and menopausal women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Публикации

• Hollstein T, Heinitz S, Basolo A, Krakoff J, Votruba SB, Piaggi P. Reduced metabolic efficiency in sedentary eucaloric conditions predicts greater weight regain in adults with obesity following sustained weight loss. Int J Obes (Lond). 2021 Apr;45(4):840-849. doi: 10.1038/s41366-021-00748-y. Epub 2021 Jan 21. PMID 33479452
• Reinhardt M, Schlogl M, Bonfiglio S, Votruba SB, Krakoff J, Thearle MS. Lower core body temperature and greater body fat are components of a human thrifty phenotype. Int J Obes (Lond). 2016 May;40(5):754-60. doi: 10.1038/ijo.2015.229. Epub 2015 Oct 26. PMID 26499440
• Schlogl M, Piaggi P, Pannacciuli N, Bonfiglio SM, Krakoff J, Thearle MS. Energy Expenditure Responses to Fasting and Overfeeding Identify Phenotypes Associated With Weight Change. Diabetes. 2015 Nov;64(11):3680-9. doi: 10.2337/db15-0382. Epub 2015 Jul 16. PMID 26185280
• Maushart CI, Senn JR, Loeliger RC, Kraenzlin ME, Muller J, Becker AS, Balaz M, Wolfrum C, Burger IA, Betz MJ. Free Thyroxine Levels are Associated with Cold Induced Thermogenesis in Healthy Euthyroid Individuals. Front Endocrinol (Lausanne). 2021 Jun 14;12:666595. doi: 10.3389/fendo.2021.666595. eCollection 2021. PMID 34194392
• Redman LM, Smith SR, Burton JH, Martin CK, Il'yasova D, Ravussin E. Metabolic Slowing and Reduced Oxidative Damage with Sustained Caloric Restriction Support the Rate of Living and Oxidative Damage Theories of Aging. Cell Metab. 2018 Apr 3;27(4):805-815.e4. doi: 10.1016/j.cmet.2018.02.019. Epub 2018 Mar 22. PMID 29576535
• Oeckl J, Janovska P, Adamcova K, Bardova K, Brunner S, Dieckmann S, Ecker J, Fromme T, Funda J, Gantert T, Giansanti P, Hidrobo MS, Kuda O, Kuster B, Li Y, Pohl R, Schmitt S, Schweizer S, Zischka H, Zouhar P, Kopecky J, Klingenspor M. Loss of UCP1 function augments recruitment of futile lipid cycling for thermogenesis in murine brown fat. Mol Metab. 2022 Jul;61:101499. doi: 10.1016/j.molmet.2022.1 PMID 35470094
• Pontzer H, Yamada Y, Sagayama H, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SG, Close GL, Cooper JA, Cooper R, Das SK, Dugas LR, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, PMID 34385400

Идентификаторы

NCT: NCT06134258 · EKNZ_2023-01401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗