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临床试验/NCT07651605
NCT07651605已完成不适用

Effect of Pistachio (Pistacia Vera L.) Consumption on Locomotor Activity and Molecular Regulation of the Circadian Clock in Adipose Tissue of Overweight Adults

Universidad Autonoma de Queretaro1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年9月13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
28
试验地点
1
主要终点
Body composition analysis

研究概览

简要总结

The goal of this study is to evaluate the effect of pistachio (Pistacia vera L.) consumption on plasma melatonin, antioxidant capacity, and circadian rhythms in overweight young adults.

The main question it aims to answer are:

  • Can the consumption of pistachios, specifically their content of compounds like phyto-melatonin, effectively regulate the human biological clock and circadian rhythms?

详细描述

This study will provide scientific evidence supporting the biological clock-regulating action of compounds present in pistachios, such as phyto-melatonin, their impact on circadian rhythm regulation, and improvement of metabolic processes altered during obesity.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No diagnosed diseases
  • Not regularly taking medications that affect melatonin synthesis or body regulation.

排除标准

  • Pregnant women
  • Individuals with night shifts, those following special diets or taking weight loss supplements
  • People who had undergone recent surgical procedures or significant weight loss in two months before the study.
  • Those taking sleep medications.
  • Individuals who had made trans meridian trips within 1 month of the evaluation,
  • Individuals with allergies, intolerances, or aversions to nuts/pistachios
  • Participants who voluntarily withdrew from the study
  • Participants who tested positive for COVID-19 during the intervention
  • Participants who experienced adverse effects.

研究组 & 干预措施

Pistacho consumption

Experimental

Participants consumed 28 g (equivalent to 5.6 mg of phytomelatonin) of pistachios each day, specifically 40 pistachios with shells, 1 hour to 30 minutes before bedtime.

干预措施: Pistacho supplementation (Other)

结局指标

主要结局

Body composition analysis

时间窗: Baseline, 2 weeks, 4 weeks

Body composition analysis (BCA, including fat mass \[FM\] and fat-free mass \[FFM\], in kg and %) was performed with a seca mBCA 514/515 medical Body Composition Analyzer (Allers Hamburg, Germany). The measurements were conducted in accordance with the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK).

Waist circumference

时间窗: Baseline, 2 weeks, 4 weeks

Waist circumference (WC, in cm) was measured using an ergonomic SECA 201 measuring tape.

Plasma melatonin

时间窗: Baseline, 2 weeks, 4 weeks

Plasma obtained from the same samples of biochemicals determinations. Plasma melatonin levels were measured before and after the intervention using a commercial plasma melatonin kit.

Circadian locomotor activity

时间窗: Through study completion during 28-days.

A temperature sensor on the wirst, an activity and body position sensor was placed on the participant's arm and a luxometer was worn on the neck with a pendant over the clothing.

Questionnaire of activity during the day

时间窗: Baseline, 2 weeks, 4 weeks

Horne and Östberg morning- evening test. Visual Analog Score with a cumulative score scale

Physical activity questionnaire (IPAQ)

时间窗: Baseline, 2 weeks, 4 weeks

Measured with the scale MET-minutes per week" (o MET-min/week)

Pittsburgh Sleep Quality Index (PSQI)

时间窗: Baseline, 2 weeks, 4 weeks

Cumulative score scale by Gobal PSQI score

次要结局

  • Concentration of metabolic and lipid parameters(Baseline, 2 weeks, 4 weeks)
  • Plasma antioxidant activity by FRAP method(Baseline, 2 weeks, 4 weeks)
  • Plasma antioxidant activity by ORAC assay.(Baseline, 2 weeks, 4 weeks)

研究者

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

Rocio Campos-Vega

Full-time research professor.

Universidad Autonoma de Queretaro

研究点 (1)

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