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临床试验/NCT07181057
NCT07181057已完成不适用

Synergistic Effects of Green Tea Extract and Ginger Supplementation on Endurance Performance and Thermal Perception in Normal and Cold Environments: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Erzurum Technical University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年3月1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
12
试验地点
1
主要终点
Positive Peak Amplitude of Event-Related Potentials During Stroop - Congruent Trials

研究概览

简要总结

Objectives: The purpose of this study is to examine how meal timing in a one-meal-a-day (OMAD) regimen influences neurocognitive outcomes.

Methods: Twelve cognitively active participants (academics, students, software engineers) will complete three randomized OMAD conditions, consuming a standardized isocaloric meal at 08:00, 12:30, or 18:00. ERPs will be recorded during a computerized Stroop task to evaluate peak amplitudes and latencies under congruent and incongruent conditions. Resting-state EEG will be measured under eyes-open and eyes-closed conditions. Behavioral performance on the Stroop task, including reaction time and accuracy, will also be assessed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Male, 20 to 45 years of age
  • •Right-handed
  • •Normal or corrected-to-normal vision
  • •Cognitively active individuals (academic staff, graduate students, or software/algorithm engineers)
  • •Regular sleep-wake schedule during the week preceding the experiment
  • •Ability to abstain from caffeine, alcohol, or psychoactive substances for at least 24 hours prior to each test session
  • •Body mass index between 18.5 and 30 kg/m²

排除标准

  • •History of neurological, psychiatric, metabolic, or sleep disorders
  • •Current use of medications that affect the central nervous system
  • •Shift work or irregular sleep patterns (verified by sleep diary)
  • •Prior experience with one-meal-a-day dietary routines
  • •Body mass index below 18.5 or above 30 kg/m²

研究组 & 干预措施

Single Group (Crossover)

Experimental

Arm Title: Morning Meal (08:00) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 08:00. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before meal) and afternoon (approximately 6 hours post-meal) sessions.

Arm Title: Midday Meal (12:30) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 12:30. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before meal) and afternoon (approximately 6 hours post-meal) sessions.

Arm Title: Evening Meal (18:00) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 18:00. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before mea

干预措施: one-meal-a-day (OMAD) (Other)

结局指标

主要结局

Positive Peak Amplitude of Event-Related Potentials During Stroop - Congruent Trials

时间窗: Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.

Maximum voltage deflection (µV) within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes, recorded during congruent Stroop trials using a 32-channel EEG system.

Latency of Positive Peak of Event-Related Potentials During Stroop - Congruent Trials

时间窗: Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.

Time point (ms) of maximum positive deflection within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes.

次要结局

  • Resting-State EEG Absolute Power (Eyes-Open and Eyes-Closed)(Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.)

研究者

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

Süleyman Ulupınar

Associate Professor of Exercise Physiology

Erzurum Technical University

研究点 (1)

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