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Идёт набор NCT02829619

Meal Timing, Genetics and Weight Loss

Наблюдательное Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obesity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Meal Timing, Genetics and Weight Loss in a Mediterranean Population

Обзор

Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims to study in a Mediterranean population the potential influence of genetics and food timing on obesity, metabolic syndrome and weight loss.

Подробное описание

Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. Furthermore, it has been shown that eating late at night when plasma melatonin concentrations are elevated, impairs glucose tolerance, particularly in MTNR1B risk allele carriers.

The main objective is to identify the mechanisms underlying the association between the timing of food intake, obesity and metabolic syndrome (MetS) in order to design effective weight loss therapies. The long-term goal is to determine the potential impact of more European, i.e., earlier meal timing on obesity, MetS and weight loss.

The challenge for the society is to develop evidence-based dietary interventions incorporating meal timing and genotype to combat the epidemic of obesity and MetS.

These goals will be achieved through three specific approaches:

* Epidemiological (observational study) (Aim 1): To assess in an obese population (n=5000) who will follow a weight loss program if clock-related (CLOCK, PER2, CRY, etc.) and melatonin-related variants (MTNR1B) interact with the timing of food intake to determine weight loss effectiveness and MetS features. * Interventional (randomized controlled trials) (Aim 2): To determine the internal mechanisms of energy balance and circadian system implicated in the differential effects of food timing (lunch) on weight loss, MetS alterations and the intestinal microbiota (n=25), and to study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance in obese women (n=100).

Prospective Follow-up (Long-term Assessment):

We will recontact all individuals who previously participated in the ONTIME study and completed a weight-loss program at nutritional clinics at least four years ago (n=5603), aiming to achieve a final sample of approximately 500 participants. Participants will attend the nutritional clinic, where body weight, height, waist and hip circumference, and total body fat will be assessed using standardized methods. Blood samples will be collected for biochemical and genetic analyses. On the first day, participants will complete questionnaires on medical history, emotional eating, environmental factors, chronotype, sleep, physical activity, and dietary intake. All variables measured are the same as those assessed at the start of the study. Additionally, for seven consecutive days, participants will record their food intake, physical activity, and sleep using a mobile application. From this population, a subpopulation of 200 participants will undergo ambulatory ECG for three days and seven-day actigraphy and temperature monitoring using Kronosensor and a light pendant. This follow-up will allow the assessment of long-term weight loss maintenance, behavioral timing, and physiological markers several years after the initial intervention.

Первичные конечные точки

  • Total weight loss [Срок оценки: weekly, during the 28 weeks of treatment]
  • Long term weight loss maintenance [Срок оценки: once at least one year after ending the treatment]
Вторичные конечные точки (12)
  • Food timing [Срок оценки: at baseline]
  • Sleep timing [Срок оценки: at baseline]
  • Siesta timing questionnaire [Срок оценки: at baseline]
  • Individual chronotype questionnaire [Срок оценки: at baseline]
  • Food habits questionnaire [Срок оценки: at baseline]
  • Total energy intake dietary questionnaire [Срок оценки: at baseline]
  • Macronutrient distribution dietary questionnaire [Срок оценки: at baseline]
  • Glycemic Index questionnaire [Срок оценки: at baseline]
  • Barriers to Weight Loss checklist [Срок оценки: at baseline]
  • Emotional eating questionnaire [Срок оценки: at baseline]
  • Physical activity questionnaire [Срок оценки: at baseline]
  • Mediterranean Diet Score questionnaire [Срок оценки: at baseline]

Критерии участия

Критерии включения

  • Body Mass Index: >25 kg/m2
  • Age: >18 years of age
  • Caucasian

Критерии исключения

  • Receiving treatment with thermogenic, lipogenic, or contraceptive drugs
  • Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
  • bulimia diagnosis, prone to binge eating
  • undergoing treatment with anxiolytic or antidepressant drugs

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • University of Murcia — Murcia

Публикации

  • Garaulet M, Vera B, Bonnet-Rubio G, Gomez-Abellan P, Lee YC, Ordovas JM. Lunch eating predicts weight-loss effectiveness in carriers of the common allele at PERILIPIN1: the ONTIME (Obesity, Nutrigenetics, Timing, Mediterranean) study. Am J Clin Nutr. 2016 Oct;104(4):1160-1166. doi: 10.3945/ajcn.116.134528. Epub 2016 Sep 14. PMID 27629052
  • Gomez-Santos C, Saura CB, Lucas JA, Castell P, Madrid JA, Garaulet M. Menopause status is associated with circadian- and sleep-related alterations. Menopause. 2016 Jun;23(6):682-90. doi: 10.1097/GME.0000000000000612. PMID 27093617
  • Corbalan-Tutau MD, Gomez-Abellan P, Madrid JA, Canteras M, Ordovas JM, Garaulet M. Toward a chronobiological characterization of obesity and metabolic syndrome in clinical practice. Clin Nutr. 2015 Jun;34(3):477-83. doi: 10.1016/j.clnu.2014.05.007. Epub 2014 May 28. PMID 24953771
  • Lopez-Guimera G, Dashti HS, Smith CE, Sanchez-Carracedo D, Ordovas JM, Garaulet M. CLOCK 3111 T/C SNP interacts with emotional eating behavior for weight-loss in a Mediterranean population. PLoS One. 2014 Jun 6;9(6):e99152. doi: 10.1371/journal.pone.0099152. eCollection 2014. PMID 24905098
  • Dashti HS, Smith CE, Lee YC, Parnell LD, Lai CQ, Arnett DK, Ordovas JM, Garaulet M. CRY1 circadian gene variant interacts with carbohydrate intake for insulin resistance in two independent populations: Mediterranean and North American. Chronobiol Int. 2014 Jun;31(5):660-7. doi: 10.3109/07420528.2014.886587. Epub 2014 Feb 18. PMID 24548145
  • Bandin C, Martinez-Nicolas A, Ordovas JM, Madrid JA, Garaulet M. Circadian rhythmicity as a predictor of weight-loss effectiveness. Int J Obes (Lond). 2014 Aug;38(8):1083-8. doi: 10.1038/ijo.2013.211. Epub 2013 Nov 15. PMID 24232497
  • Garaulet M, Smith CE, Gomez-Abellan P, Ordovas-Montanes M, Lee YC, Parnell LD, Arnett DK, Ordovas JM. REV-ERB-ALPHA circadian gene variant associates with obesity in two independent populations: Mediterranean and North American. Mol Nutr Food Res. 2014 Apr;58(4):821-9. doi: 10.1002/mnfr.201300361. Epub 2013 Oct 31. PMID 24173768
  • Garaulet M, Gomez-Abellan P. Chronobiology and obesity. Nutr Hosp. 2013 Sep;28 Suppl 5:114-20. doi: 10.3305/nh.2013.28.sup5.6926. PMID 24010751

Идентификаторы

NCT: NCT02829619 · R01DK105072-1 · R01DK105072

Первоисточники (государственные реестры)

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