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临床试验/NCT07050017
NCT07050017已完成不适用

High Milk Protein Content Reduces ad Libitum Post-exercise Energy Intake Without Altering Appetite in Active Males

Hacettepe University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
energy intake

研究概览

简要总结

This study aims to investigate the acute effects of consuming milk beverages with different protein content on subjective appetite and energy intake in healthy adults following endurance exercise. Participants will complete an endurance exercise protocol and then consume one of three beverages: a high-protein milk, a regular-protein milk, or an isoenergetic and isovolumetric carbohydrate control drink. Subjective appetite ratings will be assessed using visual analogue scales (VAS) at multiple time points after beverage consumption. Appetite-related hormonal responses, including insulin and acylated ghrelin, will be measured via blood samples. Energy intake will be assessed through an ad libitum test meal. This study will help determine whether different types of milk consumed post-exercise influence appetite regulation, hormonal response, and subsequent energy intake.

详细描述

The primary objective of this randomized, double-blind, crossover clinical trial is to evaluate the acute effects of post-endurance exercise consumption of milk beverages with varying protein content on subjective appetite, circulating appetite-related hormones, and subsequent ad libitum energy intake in healthy, recreationally active adult males. The study will recruit at least 12 healthy male participants aged 18-39 years who have been regularly engaged in endurance-based physical activity (e.g., cycling, running, triathlon, orienteering, team sports) for a minimum of one year, with a training frequency of at least three sessions per week lasting 60-90 minutes each. Participants will complete five laboratory visits under a crossover design with a minimum one-week washout period between intervention conditions. The first two sessions will consist of pre-study visits (screening, anthropometric assessments, VO₂max testing, and familiarization). The remaining three visits will involve the ingestion of one of the following beverages in a randomized order: standard-protein milk (0 g protein), high-protein milk (30 g protein), or an isoenergetic carbohydrate-based control beverage (0 g protein). All beverages will be isocaloric and isovolumetric and provided in opaque bottles to ensure double-blind conditions. On each intervention day, participants will perform a steady-state endurance exercise protocol using a calibrated cycle ergometer, followed immediately by the ingestion of one of the test beverages. Appetite will be assessed subjectively using validated Visual Analogue Scales (VAS) at predefined intervals. Venous blood samples will be collected to analyze concentrations of insulin and acylated ghrelin as objective biomarkers of appetite regulation. One hour after beverage consumption, an ad libitum test meal will be provided to quantify subsequent energy intake. The total caloric intake and macronutrient distribution will be recorded and analyzed. This study is designed to provide insight into the role of post-exercise milk consumption-specifically the influence of protein content-on short-term appetite modulation and energy intake regulation in recreationally trained individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Care Provider)

盲法说明

The beverages will be administered in opaque bottles in a randomized order. Both the participants and the researchers will remain blinded to the content of the beverages until the end of the study.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •The study will include healthy, physically active male participants aged 18-39 years who have been engaging in recreational endurance sports (such as cycling, running, triathlon, orienteering, or team sports) for at least one year, with a minimum frequency of 3 sessions per week lasting 60-90 minutes.

排除标准

  • •Current smoker
  • •Chronic or excessive alcohol consumption
  • •Use of supplements and/or chronic medications that may affect appetite
  • •Presence of cardiac, hepatic, renal, pulmonary, neurological, hematological, gastrointestinal, diabetic, thyroid, or psychiatric disorders, and/or musculoskeletal conditions that may limit exercise participation
  • •Allergy or intolerance to any of the foods or beverages to be consumed during the study
  • •Unstable body weight (e.g., weight loss greater than 1 kg in the past week)
  • •Currently following a weight-loss diet
  • •Diagnosed eating disorders or individuals who cognitively restrict food intake (to be assessed using the Three-Factor Eating Questionnaire)

研究组 & 干预措施

carbohydrate control drink: isoenergetic and isovolumetric with milk beverages.

Active Comparator

Isoenergetic and isovolumetric with milk beverages

干预措施: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. (Behavioral)

regular milk

Experimental

containing 15 g protein

干预措施: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. (Behavioral)

high-protein milk

Experimental

containing 30 g protein

干预措施: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. (Behavioral)

结局指标

主要结局

energy intake

时间窗: From enrollment to the end of treatment at 3 weeks.

Energy intake will be measured through an ad libitum meal provided after the exercise.

次要结局

  • acylated ghrelin (pg/mL)(From enrollment to the end of treatment at 3 weeks.)
  • Insulin (pmol/L)(From enrollment to the end of treatment at 3 weeks.)
  • subjective appetite(From enrollment to the end of treatment at 3 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Tunçil

Research Assistant

Hacettepe University

研究点 (1)

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