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临床试验/NCT03098381
NCT03098381已完成不适用

Alteration in Body Composition and Metabolic Profile Without Changes on Serum Leptin and Adiponectin Levels During Ramadan Fasting in Healthy Men

Chulalongkorn University0 个研究点目标入组 27 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
主要终点
body composition

研究概览

简要总结

One of religious duties for all healthy adult Muslims is fasting during Ramadan, the ninth month of Islamic lunar calendar. In this month, Ramadan observance fasted (no food and drink) from dawn to dusk. Studies demonstrated daytime fasting may pose a positive significant effect on metabolic health. Thus, this present study aimed to determine the effect of Ramadan fasting on body composition, metabolic profile, serum leptin and adiponectin levels in healthy men.

详细描述

Outcome measurements were taken at before (baseline) and at the end of Ramadan (after Ramadan fasting) on body composition, metabolic profile (fasting plasma glucose, insulin, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR), serum leptin and adiponectin, ratio of leptin to adiponectin in 27 healthy men (19-31 years) Muslim in Bangkok, Thailand.

Subjects Twenty-nine subjects fulfilled inclusion criteria including: age 19-40 years, Muslim men fasted completely, and no known of any metabolic-related diseases. Subjects with diseases and/or intake of any medication and dietary supplement, smoking, and alcohol drinking were excluded. After Ramadan fasting, 27 subjects completed the study.

The study protocol was approved by the Ethical Review Committee for Research Involving Human Research Participants, Health Science Group, Chulalongkorn University, Bangkok, Thailand (COA no. 136/2558).Written informed consent was obtained from all subjects prior to enrolling to the study. Subject's anonymity was preserved.

Study design Research visit was conducted at Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand at before (earlier days of Ramadan) and after (third week of Ramadan) to collect the outcome measurements including anthropometry, body composition, metabolic profile, serum leptin and adiponectin levels, and ratio of leptin to adiponectin. The dietary intake of 2 weekday and one weekend day and physical activity were recorded each week during Ramadan in food record booklet. Energy intake and macronutrients composition including carbohydrate, protein and fat will be analysed by registered dietitian.

Anthropometry and body composition measurements Weight, Body Mass Index (BMI), and percent body fat were measured at baseline (week-0) and the end of Ramadan fasting period (week-4). Body weight, and percent body fat mass were assessed using a constant current source with a high frequency current (50kHz, 500μA)-bioelectrical impedance analyzer (BIA) (MC-980MA body composition analyzer, TANITA corporation, Tokyo, JAPAN). The subject was requested to dress in light attire and bare feet. The 8 polar electrodes were positioned so that electric current was supplied from the electrodes on the tips of the toes of both feet and the fingertips of both hands, and voltage is measured on the heel of both feet and the near side of both hands. Body Mass Index (BMI) was calculated as weight/height2 (in kilograms per square meter). Waist and hip circumferences were measured by using a standard rounded tape at a point right above the iliac crest on the mid-axillary line at minimal respiration (for waist) and in a horizontal plane at the level of the maximal extension of the buttocks (for hip) to the nearest 1.0 cm.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • age 19-40 years
  • Muslim men
  • fasted completely during Ramadan
  • no known of any metabolic-related diseases.

排除标准

  • any diseases
  • intake of any medication and dietary supplement
  • alcohol drinking

结局指标

主要结局

body composition

时间窗: 1 months

fat mass changes after 1 month of ramadan fasting in 27 participants

次要结局

  • Metabolic profile(1 month)
  • Serum leptin and adiponectin measurements(1 month)

研究者

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

Suwimol Sapwarobol

Program Director, Nutrition and Dietetics Program

Chulalongkorn University

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