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临床试验/NCT06185634
NCT06185634招募中不适用

Impact of Pasta Consumption Timing on Multiple Health Outcomes

Azienda Ospedaliero-Universitaria Careggi2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Sleep quality

研究概览

简要总结

To date, the optimal timing for pasta consumption remains uncertain. Based on recent evidence in the field of chrono-nutrition, it is speculated that eating pasta at dinner may have a negative impact on cardio-metabolic health. Carbohydrate intake during a period of minimal glucose tolerance could potentially alter the glycaemic profile and increase the risk of overweight and obesity. Conversely, other studies indicate that consuming carbohydrates at dinner may enhance sleep efficiency and quality. Thus, the aim of this study is, for the first time, to evaluate whether there are discernible differences between consuming pasta at lunch or dinner for the human health.

详细描述

Background:

Pasta plays an indisputable role in the Mediterranean diet pyramid. Indeed, it is an excellent source of carbohydrates that can be part of a varied, balanced, and healthy diet. Despite this, more and more people are avoiding it because they consider it too caloric and associate it with weight gain, especially if eaten in the evening.

While it is known with certainty that the consumption of pasta, in the right quantities, is associated with positive health effects, there is limited information on the optimal time to consume it. The most common hypothesis is that it is better to consume it at lunch, as metabolism undergoes a physiological and progressive reduction as the evening approaches. Furthermore, recent findings in the field of chrono-nutrition have highlighted that glucose tolerance is high during the day and minimal during the night, suggesting that consuming a high amount of carbohydrates in the evening may predispose to weight gain and a worsened cardio-metabolic profile. On the other hand, according to some studies, consuming carbohydrates in the evening may ensure good sleep quality, as they are an excellent source of tryptophan, an amino acid that promotes serotonin production, also known as the sleep hormone.

Recently, some studies on animal models have suggested that the timing of carbohydrate consumption could also impact the composition and functionality of the gut microbiota. For example, it has been observed that the production of short-chain fatty acids (SCFA) fluctuates throughout the day under the control of the host's circadian rhythms. Considering that SCFA are produced from carbohydrates and are fundamental regulators for many metabolic processes, it could be extremely interesting to explore the relationship between "when carbohydrates are consumed" and microbial functionality.

In conclusion, to date, studies that have evaluated the timing of carbohydrate consumption are limited and rely on physiological and chrono-biological assumptions rather than experimental evidence. Consequently, it is not known whether consuming pasta at lunch or dinner, in the right quantities, may have effects on human weight and health.

研究设计

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

盲法说明

In this study it will not be possible to blind the experimenters and participants. Blinding will be impossible for the experimenters, as they will provide the food plan with the dietary intervention. Blinding will also not be possible for the participants, who will have to eat pasta only at dinner for 3 months and only at lunch for the same period of time.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • normal weight condition (BMI=18.5-24.9 kg/m2)
  • age between 18 and 65 years
  • willing to give informed consent

排除标准

  • subjects who were involved in night work, planned long-distance jet travel during the study period, had irregular sleeping schedules or were taking any drugs known to affect sleep or metabolism
  • presence of current chronic illness or unstable condition (e.g., cardiovascular disease, chronic liver disease, inflammatory bowel disease)
  • current or recent (past 2 months) use of antibiotics or probiotics
  • pregnancy or intention to become pregnant in the next 12 months
  • breastfeeding

结局指标

主要结局

Sleep quality

时间窗: 7 months

The assessment of sleep quality will be done by actigraphy and the following parameters will be evaluated: sleep onset time, end of sleep time, waking after sleep onset, total sleep time, sleep efficiency, number of awakenings, duration of awakenings, movement index, activity index and sleep regularity index.This assessment will be carried out at the beginning and end of each of the two intervention phases.

次要结局

  • IL-6 changes(7 months)
  • Weight change(7 months)
  • Total cholesterol changes(7 months)
  • Uric acid changes(7 months)
  • LDL-cholesterol changes(7 months)
  • Gamma-glutamyl transferase changes(7 months)
  • Urea changes(7 months)
  • Creatinine changes(7 months)
  • Body mass index (BMI) changes(7 months)
  • Fat mass changes(7 months)
  • Basal Metabolic Rate(7 months)
  • Fasting Blood Glucose changes(7 months)
  • Glycated Haemoglobin (HbA1c) changes(7 months)
  • HDL-cholesterol changes(7 months)
  • Triglycerides changes(7 months)
  • Gut microbiota changes(7 months)
  • Ghrelin changes(7 months)
  • C-Peptide YY(7 months)
  • Insulin changes(7 months)
  • Aspartate transaminase changes(7 months)
  • Alanine transaminase changes(7 months)
  • Homocysteine changes(7 months)
  • TBARS changes(7 months)
  • ROS changes(7 months)
  • Individual circadian rhythms(7 months)
  • Leptin changes(7 months)

研究者

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

Francesco Sofi

Professor

Azienda Ospedaliero-Universitaria Careggi

研究点 (2)

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