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Набор скоро начнётся NCT06809296

Assessment of the Effects of Acute Exposure to Cold and Heat on Appetite

Наблюдательное Appetite

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: Appetite. Базовые параметры: 18 лет — 40 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluating the Effects of Acute Exposure to Cold and Heat on Appetite: Impact of Serving Food Temperature (Hot and Cold Meals)

Обзор

Military personnel and athletes have a very high energy expenditure, which is increased during certain key periods (intense training, competition and missions). Compensating for this expenditure through adequate energy intake can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, food availability), leading these populations to regularly find themselves in an energy deficit situation (intake below requirements). If this situation persists, it could impair physical and cognitive performance, as well as major physiological functions. Among the many constraints to which military personnel and athletes are subjected (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficiency, the impact of thermal environmental constraints is very imperfectly known. Seasonal impact and travel to countries with very different thermal environments from temperate countries can lead these populations to work in cold and hot conditions for long periods. Understanding how exposure to hot and cold alters appetite and energy intake is therefore of the high importance. Our previous "TEMPCA" study highlighted a modulation of preferences for warm or cold foods depending on the exposure environment. By being able to adapt their food intake to these preferences, subjects were able to maintain a decent energy intake. The primary objective of this study is to determine the effect of the temperature of the food served (hot or cold) on changes in food intake during acute exposure to hot and cold. We hypothesized that adapting the temperature of the food served according to the exposure environment (hot in a cold environment and cold in a hot environment) would enable adequate levels of energy intake. Secondary objectives are to determine the influence of the environment on the levels of interstitial glucose during the preprandial period and to investigate the impact of thermal exposure (modulation of core temperature) on the modulation of quantities consumed and energy produced by digestion (postprandial thermogenesis). Forty participants (between 18 and 40 yo, male or female, active, lean, and healthy) will carry out 3 experimental sessions in which only the thermal environment will differ: cold condition (15°C), neutral condition (25°C) and warm condition (35°C). They will be divided into two groups, the first of which will be offered a cold meal during the three sessions (Cold Meal - CM) and the second a warm meal during the three sessions (Warm Meal - WM). They will all wear the same outfit designed to be offer perfect thermal comfort at 25 °C. Briefly, each session will start at 8:30am after eating a standardized breakfast. Body mass and ad libitum water intake will be frequently monitored to identify possible dehydration. Thermal comfort and sensation and subjective appetite will be regularly assessed using visual analog scale. From 11:00am to 01:00pm, all participants will be isolated and all temporal cues will be removed. At 01:00pm, an ad libitum meal (warm or cold) will be served in large quantities. The dishes will be weighed before and after the meal to assess energy intake. Before and after the meal, resting metabolism will be measured during 30 min in a supine position using indirect calorimetry and food preferences for high-fat/low-fat, savory/sweet, warm/cold foods, and fluid/solid foods will be assessed using the Leeds Food Preference Questionnaire.

Первичные конечные точки

  • Energy intake [Срок оценки: From date of the first experimental session until the last experimental session]
  • Subjective appetite [Срок оценки: From date of the first experimental session until the last experimental session]
  • Food preferences [Срок оценки: From date of the first experimental session until the last experimental session]
Вторичные конечные точки (5)
  • Rectal temperature [Срок оценки: From date of the first experimental session until the last experimental session]
  • Skin temperature [Срок оценки: From date of the first experimental session until the last experimental session]
  • Thermal sensation and comfort [Срок оценки: From date of the first experimental session until the last experimental session]
  • Levels of interstitial glucose [Срок оценки: From date of the first experimental session until the last experimental session]
  • Resting energy metabolism [Срок оценки: From date of the first experimental session until the last experimental session]

Критерии участия

Критерии включения

  • Active (>3 h/w of physical activites)
  • Affiliated to the social security
  • Usual breakfast eaters

Критерии исключения

  • Unusual or irregular meal pattern
  • Too high dietary restrictive profile assessed by the TFEQ-21
  • Bad sleepers (< 6h/night)
  • Presenting a metabolic condition
  • BMI lower than 18 or higher than 30
  • Chronic medication (at the exception of the contraceptive pills)
  • Regular smoker (more than 2 cigarettes per day)
  • Regular alcohol consumer (more then 1 glass per day)
  • Vegetarian
  • Following a confessional diet (hallal, casher)
  • Do not speak fluently French

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Tassone EC, Baker BA. Body weight and body composition changes during military training and deployment involving the use of combat rations: a systematic literature review. Br J Nutr. 2017 Mar;117(6):897-910. doi: 10.1017/S0007114517000630. PMID 28452292
  • Wasse LK, King JA, Stensel DJ, Sunderland C. Effect of ambient temperature during acute aerobic exercise on short-term appetite, energy intake, and plasma acylated ghrelin in recreationally active males. Appl Physiol Nutr Metab. 2013 Aug;38(8):905-9. doi: 10.1139/apnm-2013-0008. Epub 2013 May 1. PMID 23855280
  • Zakrzewski-Fruer JK, Horsfall RN, Cottrill D, Hough J. Acute exposure to a hot ambient temperature reduces energy intake but does not affect gut hormones in men during rest. Br J Nutr. 2021 Apr 28;125(8):951-959. doi: 10.1017/S0007114520002792. Epub 2020 Jul 22. PMID 32693846
  • Charlot K. Negative energy balance during military training: The role of contextual limitations. Appetite. 2021 Sep 1;164:105263. doi: 10.1016/j.appet.2021.105263. Epub 2021 Apr 20. PMID 33862189
  • Millet J, Siracusa J, Tardo-Dino PE, Thivel D, Koulmann N, Malgoyre A, Charlot K. Effects of Acute Heat and Cold Exposures at Rest or during Exercise on Subsequent Energy Intake: A Systematic Review and Meta-Analysis. Nutrients. 2021 Sep 28;13(10):3424. doi: 10.3390/nu13103424. PMID 34684424
  • Coca M, Besancon L, Erblang M, Bourdon S, Gruel A, Lepetit B, Beauchamps V, Tavard B, Oustric P, Finlayson GS, Thivel D, Malgoyre A, Tardo-Dino PE, Bourrilhon C, Charlot K. Twenty four-hour passive heat and cold exposures did not modify energy intake and appetite but strongly modify food reward. Br J Nutr. 2024 Jul 28;132(2):209-226. doi: 10.1017/S0007114524000825. Epub 2024 Apr 18. PMID 38634266

Идентификаторы

NCT: NCT06809296 · 2024PPRC09 · 2024-A02285-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗