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临床试验/NCT06226623
NCT06226623已完成不适用

Effects of Coconut Consumption on Body Composition in Healthy Adult Individuals: a Randomized Controlled Study

Muğla Sıtkı Koçman University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Body Composition

研究概览

简要总结

This research is a randomized controlled study. The aim of the study is to investigate the effects of coconut on body composition, compare our results with other studies in the literature and contribute to the field.

The research was single-centered and was carried out with the academic, administrative and other personnel of Muğla Sıtkı Koçman University Faculty of Health Sciences. Volunteer, healthy adults between the ages of 18-65, without any physical disability or uncontrolled chronic systemic disease or problems with reading and comprehension, were included in the study, regardless of gender. Individuals who were following an existing diet program, having a history of pregnancy and cancer, having undergone acute abdominal surgery, or having unstable conditions due to cardiovascular and endocrine systems were not included in the study. Participants who did not attend the four-week healthy nutrition training were excluded from the study.

A list of all staff members at the faculty was created. The population of the research consists of 74 personnel. Randomization was made to the experimental and control groups by the sealed envelope selection method.

All participants were given 4 weeks of healthy nutrition training. The amount of energy required by the participants was calculated. A healthy nutrition program was prepared according to the calculated daily energy needs of the participants. The control group was given only a healthy nutrition program. The intervention group was asked to consume 50 g of fresh coconut daily in addition to the healthy nutrition program. Participants' compliance with the healthy nutrition program and coconut consumption was high.

Anthropometric measurements of the volunteer individuals participating in the study were taken before and after the intervention. To determine the body composition of individuals, a bioelectric impedance analyzer was used, a portable height meter was used to measure height, and waist circumference was measured using a standard non-stretchable tape measure. Body Mass Index (BMI) was calculated.

详细描述

This research is a randomized controlled study. The research was single-centered and was carried out with the academic, administrative and other personnel of Muğla Sıtkı Koçman University Faculty of Health Sciences. Participants who agreed to participate in this study and were deemed eligible were given detailed information about the research and then an informed consent form was presented in writing and signed. The study was conducted within the framework of the standards and ethical criteria in the Declaration of Helsinki and was approved by Bahçeşehir University Clinical Research Ethics Committee (2018-05/05). This research was written according to CONSORT criteria.

The study was conducted between January and July 2018. Volunteer, healthy adults between the ages of 18-65, without any physical disability or uncontrolled chronic systemic disease or problems with reading and comprehension, were included in the study, regardless of gender. Individuals who were following an existing diet program, having a history of pregnancy and cancer, having undergone acute abdominal surgery, or having unstable conditions due to cardiovascular and endocrine systems were not included in the study. Participants who did not attend the four-week healthy nutrition training were excluded from the study.

A list of all faculty members was created by the researchers. Randomization was made to the experimental and control groups in a 1:1 ratio using the sealed envelope selection method. Data was collected between April and May 2018.

Power analysis was used to calculate the sample size of this study. Since G Power power analysis was performed with a 95% confidence interval and an effect size of 0.8, it was found that 20 participants per group should be included in the study. The population of the research includes 74 personnel. In this study, the target for the number of samples is to reach the universe. However, the sample of the study consisted of 62 personnel who met the inclusion criteria and agreed to participate in the study voluntarily.

All participants were given 4 weeks of healthy nutrition training. Participants' basal metabolic rates were calculated according to gender and body weight (kg) using the Schofield equation. The equation appropriate for each participant's age was used. The daily energy requirement of the participants was calculated by adding an activity factor of 1.3 to the calculated basal metabolic rate. A healthy nutrition program was prepared according to the calculated daily energy needs of the participants. While preparing this program, WHO and Turkey-Specific Healthy Nutrition Guide (TÜBER) were used. In the individual healthy nutrition program, 55% carbohydrates, 15% protein and 30% fat macronutrients are provided. Total cholesterol in the nutrition program was kept at 300 mg and below. The control group was given only a healthy nutrition program. The intervention group was asked to consume 50 g of fresh coconut daily in addition to the healthy nutrition program. Coconuts were regularly provided to the participants as a whole fruit by the researchers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Without physical disability
  • No problems with reading and comprehension
  • Those who do not have an existing diet program,
  • Non pregnant
  • Not having cancer,
  • Those who have not had acute abdominal surgery
  • Without unstable conditions originating from the cardiovascular and endocrine systems
  • Those who completed the four-week healthy nutrition training
  • Voluntary based
  • Healthy adults

排除标准

  • Physically disabled
  • Having problems with reading and comprehension
  • Have an existing diet program
  • Suffering from cancer
  • Those who have had acute abdominal surgery
  • Unstable condition originating from the cardiovascular and endocrine systems
  • Those who did not complete the four-week healthy nutrition training
  • Those who do not want to participate in the study
  • Adults who are not healthy

结局指标

主要结局

Body Composition

时间窗: Anthropometric measurements of the participants were taken before and after the intervention. Anthropometric measurements were made 5 days before the intervention and 5 days after the intervention, for a total of 10 days.

Height was measured with a portable height meter, weight, body fat percentage, and body fat mass were determined with a BIA device, and waist circumference was determined with a rigid tape measure.

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Uner

Lecturer

Muğla Sıtkı Koçman University

研究点 (2)

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