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Идёт набор NCT06096233

Effect of Exercise on Appetite in Response to Meals

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: Bouts of 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 Post-meal Appetite, Appetite-Regulatory Hormones, and Energy Intake in Healthy Men

Обзор

This clinical trial's primary aim is to investigate the acute effect of two exercise bouts (short \[10 minutes\] and long \[30 minutes\]) on appetite and appetite-regulatory hormone responses to a standard meal test. The secondary aim is to investigate when the changes in appetite and appetite-regulatory hormones occur during exercise. As an exploratory aim, the researchers will test if the two exercise bouts influence ad libitum energy intake in the periods after the standard meal test. The researchers will compare three groups (control, short exercise, and prolonged exercise) to see if the exercise bouts affect appetite, appetite-regulatory hormones, and energy intake in healthy men.

Подробное описание

Study Design

Screening visit Before conducting the main experiments, the participants will attend a screening visit where consent will be obtained, and they will complete questionnaires to assess health, food preferences, and physical activity. The researchers will then measure the participants' height, weight, waist circumference, and body composition.

After the researchers confirm the eligibility criteria, participants will take part in two treadmill tests to establish maximum oxygen uptake test (V̇O2 max) (Broom et al. 2017).

Experimental design After the screening visit, the participants will complete three main experiments (control, short high-intensity exercise, and prolonged high-intensity exercise) in a counter-balanced design. All experiments began at \~0930, following an overnight fast of at least 10 hours. Participants will consume a prescribed meal in the evening before each main experiment. Following this meal, participants are only allowed to drink water until the start of the main experiments.

At the beginning of the exercise conditions, participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged) at a speed estimated to elicit a 75% V̇O2 peak, followed by rest in the laboratory. In the control condition, the researchers will follow the same protocols except that the participants will not perform any exercise. The participants will have a standardized meal after exercise and then an ad libitum buffet meal afterward.

During each experiment, the researchers will assess appetite ratings using 100 mm visual analog scales (Flint et al. 2000). The researchers will also collect blood samples to examine ghrelin, peptide YY, glucagon-like peptide 1, and possibly other blood-borne measures.

Вмешательства

  • Другое Bouts of Exercise
    The participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged).

Первичные конечные точки

  • Change in Peptide-YY (PYY) [Срок оценки: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours]
  • Change in Ghrelin [Срок оценки: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours]
  • Change in Glucagon-Like Peptide-1 (GLP-1) [Срок оценки: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours]
  • Change in subjective appetite sensations [Срок оценки: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, and 6 hours]
Вторичные конечные точки (2)
  • Energy Intake [Срок оценки: At 5 hours]
  • Macro-nutrient Intake [Срок оценки: At 5 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.
  • Have food allergies.
  • Have significant contraindications to exercise (e.g., an injury that would inhibit running).
  • Smoking.
  • Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.

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 at Glasgow Royal Infirmary — Glasgow

Публикации

  • 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
  • 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

Идентификаторы

NCT: NCT06096233 · 200220449

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗