跳至主要内容
临床试验/NCT07247513
NCT07247513已完成不适用

Glycaemic Responses to a Food Intake Sequence Intervention Under Free-living Conditions in Elite Female Athletes

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年11月24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
22
试验地点
2
主要终点
Incremental interstitial glucose peak after a standardised test meal

研究概览

简要总结

The goal of this clinical trial is to investigate the impact of a food intake sequence intervention under free-living conditions on glycaemic responses in elite female athletes. Specifically, the main questions it aims to answer are:

  1. Does consuming breakfast in different food intake sequences alter postprandial interstitial glucose responses?
  2. Does consuming a pre-exercise meal in different food intake sequences alter interstitial glucose responses during exercise?
  3. Does consuming the last meal of the day in different food intake sequences alter nocturnal interstitial glucose responses?

To address these questions, researchers will compare eating the dietary sources of rapidly absorbed carbohydrate (CHO) at the end (CHO-last meal pattern) or at the start (CHO-first meal pattern) of standardised mixed meals, at different times of day, in a randomised, counterbalanced, crossover design.

Participants will wear a blinded continuous glucose monitor (CGM) for 6 consecutive days during a training camp. Throughout the study, they will be provided with buffet meals, at the same time and location each day. Dietary intake will be ad libitum, except for breakfast and supper, for which participants will select a preferred composition (ingredients, preparation methods, portion sizes) to replicate across study days. In all ad libitum meals (i.e., lunch, snacks, and dinner), they will be asked to maintain their assigned food intake sequence.

  • On day 1, athletes will eat freely. An educational session on the study protocol and food sequence manipulation will be delivered, and informed consent, questionnaires, screening assessments, and CGM fitting will be completed. Data collected by the CGM during the first 24 hours will be disregarded due to sensor stabilisation. Hence, this period will serve for familiarisation only.
  • On days 2 and 3, one group will eat the last meal of the day (i.e., supper) in a CHO-last meal pattern, while the other will follow a CHO-first meal pattern; on days 3 and 4 one group will eat breakfast in a CHO-last meal pattern while the other will follow a CHO-first meal pattern.
  • On days 4 and 5 (supper) and 5 and 6 (breakfast), participants in each group will adhere to the alternate condition.

Concurrent data on potential confounding factors (e.g., dietary intake, physical activity, internal and external load during training sessions/competition, sleep quantity and quality, menstrual cycle phase/status) will be collected.

Due to the short camp duration, implementing a one-day washout period will not be feasible. Therefore, repeated measurements over two consecutive days per condition will be obtained to minimise carryover effects of the food intake sequence from prior meals on end-of-intervention data (the final 24 hours per condition), and to assess intraindividual consistency of outcomes at matched-times and standardised settings.

Glycaemic responses will be compared within-participant between food intake sequences using linear mixed models with random intercepts, to account for repeated measures, interindividual variability, and potential missing data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

盲法说明

It is not possible to blind participants or researchers envolved in data collection to the intervention assigned in each period due to the nature of the intervention and comparator (food intake sequence of the same elements within a meal). However, both will be blinded to CGM data throughout the study.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Adult (18-64 years old)
  • •Elite athletes (meeting training and performance caliber criteria ≥Tier 4; McKay et al., 2022)
  • •Healthy (meeting the

排除标准

  • •for medical conditions)
  • •Normal glucose tolerant according to the latest review standards of the American Diabetes Association (ElSayed et al., 2024): HbA1c <5.7%, fasting plasma glucose <5.6 mmol/L (100 mg/dL), or 2-h plasma glucose <7.8 mmol/L (140 mg/dL) during a 75-g OGTT
  • •Able and willing to provide informed consent and safely comply with study procedures
  • •Exclusion Criteria:
  • •Any medical condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias into the experiment (e.g. pregnancy, alcohol or substance abuse; any condition affecting the glucose and lipid metabolism or appetite, reviewed on a case by case basis)
  • •Any reported medication or supplementation that may interfere with the glucose metabolism (e.g., acarbose, aspirin, berberine, insulin, metformin, semaglutide, sulfonylureas, thiazide diuretics, thiazolidinediones, vitamin C). Other medication and supplementation will be reviewed on a case by case basis.
  • •Recent change in body mass (± 2 kg in the last 2 months)

研究组 & 干预措施

CL - CF

Experimental

The interventions (carbohydrate-last meal pattern (CL) or carbohydrate-first meal pattern (CF)) will be delivered in random order. If participants are allocated to this study arm, they will receive the CL on the first 2 days and the CF on the next 2 days of the study period.

干预措施: Carbohydrate-last meal pattern (Other)

CL - CF

Experimental

The interventions (carbohydrate-last meal pattern (CL) or carbohydrate-first meal pattern (CF)) will be delivered in random order. If participants are allocated to this study arm, they will receive the CL on the first 2 days and the CF on the next 2 days of the study period.

干预措施: Carbohydrate-first meal pattern (Other)

CF - CL

Active Comparator

The interventions (carbohydrate-last meal pattern (CL) or carbohydrate-first meal pattern (CF)) will be delivered in random order. If participants are allocated to this study arm, they will receive the CF on the first 2 days and the CL on the next 2 days of the study period.

干预措施: Carbohydrate-last meal pattern (Other)

CF - CL

Active Comparator

The interventions (carbohydrate-last meal pattern (CL) or carbohydrate-first meal pattern (CF)) will be delivered in random order. If participants are allocated to this study arm, they will receive the CF on the first 2 days and the CL on the next 2 days of the study period.

干预措施: Carbohydrate-first meal pattern (Other)

结局指标

主要结局

Incremental interstitial glucose peak after a standardised test meal

时间窗: 0-120 minutes following a standardised test meal

Difference between CHO-last and CHO-first meal patterns in the incremental interstitial glucose peak (mmol/L) adjusted for baseline, following standardised breakfasts (independent of and coinciding with subsequent exercise) and the end-of-intervention (days 3 and 5) standardised supper, assessed using a blinded continuous glucose monitoring system (Freestyle Libre Pro IQ).

次要结局

  • Incremental area under the interstitial glucose curve after a standardised test meal(0-120 minutes following a standardised test meal)
  • Time-to-peak interstitial glucose after a standardised test meal(0-120 minutes following a standardised test meal)
  • Time out of interstitial glucose range after a standardised test meal(0-180 minutes following a standardised test meal)
  • Interstitial glucose dip after a standardised test meal(0-180 minutes following a standardised test meal)
  • Within-day coefficient of variation of interstitial glucose(24 hours)
  • Mean amplitude of glycaemic excursions (MAGE)(24 hours)
  • Large amplitude of glycaemic excursions (LAGE)(24 hours)
  • Within-day time out of interstitial glucose range(24 hours)
  • Between-day glycaemic variability(24 hours)
  • Interstitial glucose concentrations during specific activities(24 hours)
  • Within-day standard deviation of interstitial glucose(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验