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Идёт набор NCT06895837

Effect of Exercise on Appetite in Response to Meals During Energy Restriction

Без фазы С лечением Healthy

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
В протоколе указаны: Severe-energy restriction, Severe-energy restriction with exercise.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 65 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Acute Effect of Exercise on Appetite, Appetite-Regulatory Hormones, and Energy Intake During Energy Restriction in Healthy Men

Обзор

This study's primary aim is to investigate the acute effect of an exercise bout (30 minutes) on appetite and appetite-regulatory hormone responses during energy restriction. The researchers will also test if the exercise bout influences ad libitum energy intake after a period of energy restriction. The researchers will compare three groups (control, severe-energy restriction, and severe-energy restriction with exercise) to see if exercise bout, during energy restriction, affects appetite, appetite-regulatory hormones, and energy intake in healthy men.

Подробное описание

Before the main experiments are conducted, participants will attend a screening visit where the participants will provide consent and complete questionnaires that assess their health, food preferences, and physical activity levels. Researchers will then measure the participants' height, weight, waist circumference, and body composition.

Once the eligibility criteria are confirmed, participants will participate in two treadmill tests to establish their maximum oxygen uptake (V̇O2 max).

After the screening visit, participants will participate in three main experiments, each lasting 24 hours: control, severe energy restriction, and severe energy restriction with exercise. These experiments will be conducted in a counterbalanced design. Each experiment will start around 9:30 AM, following an overnight fast of at least 10 hours. Participants will have a prescribed meal in the evening before each main experiment. After this meal, the participants are only allowed to drink water until the start of the main experiments.

During the exercise trial, participants will begin by running on a treadmill for 30 minutes at a speed estimated to achieve 75% of their V̇O2 peak, followed by a rest period in the laboratory. The same protocol will be followed in the control and severe-energy trials, except that no exercise will be performed. Participants will rest in the laboratory during both the control and energy-restricted trials. In the control trial, the participants will receive 100% of their estimated energy needs; in the energy-restricted trials, the participants will receive only 25%.

The participants will have standardized breakfast and lunch meals at 1h and 5h, respectively. At 24h, participants will be provided an ad libitum buffet meal in a private eating room.

The researchers will assess appetite ratings in each experiment using 100 mm visual analog scales. The researchers will also collect blood samples to analyze ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP-1), and potentially other blood-borne measures.

Вмешательства

  • Другое Severe-energy restriction
    The participants will receive only 25% of their estimated energy needs.
  • Другое Severe-energy restriction with exercise
    The participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs.

Первичные конечные точки

  • Change in Peptide-YY (PYY) [Срок оценки: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours]
  • Change in Ghrelin [Срок оценки: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours]
  • Change in Glucagon-Like Peptide-1 (GLP-1) [Срок оценки: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours]
  • Change in subjective appetite sensations [Срок оценки: At 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 23, 24, and 25 hours]
Вторичные конечные точки (2)
  • Energy Intake [Срок оценки: At 24 hours]
  • Macro-nutrient Intake [Срок оценки: At 24 hours]

Критерии участия

Критерии включения

  • Males aged 18 years or older.
  • Have stable body mass for at least six months (within ±2 kg).

Критерии исключения

  • Females
  • People who are younger than 18 or older than 65 years old.
  • Following a special diet (e.g. weight loss, vegetarian or vegan, etc.).
  • Have food allergies related to the study.
  • Have significant contraindications to exercise (e.g., an injury that would inhibit running).
  • Smoking.
  • Taking any medications.
  • Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.
  • Have any mental health conditions.

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

Великобритания · 1 центр
  • New Lister Building, Glasgow Royal Infirmary — Glasgow

Публикации

  • Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. PMID 10702749
  • Broom DR, Miyashita M, Wasse LK, Pulsford R, King JA, Thackray AE, Stensel DJ. Acute effect of exercise intensity and duration on acylated ghrelin and hunger in men. J Endocrinol. 2017 Mar;232(3):411-422. doi: 10.1530/JOE-16-0561. Epub 2016 Dec 20. PMID 27999089

Идентификаторы

NCT: NCT06895837 · 200240250

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗