NCT06226623

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 18, 2024

Last Update Submit

January 25, 2024

Conditions

Keywords

Coconut, Body Composition, Healthy Eating

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    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.

    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.

Study Arms (2)

Intervention

EXPERIMENTAL

Participants were given 4-week healthy nutrition training. Participants' basal metabolic rates were calculated according to gender and body weight (kg) using the Schofield equation. The appropriate equation 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 were provided. Total cholesterol of the nutrition program was kept at 300 mg and below. The intervention group was asked to consume 50 g of fresh coconut daily in addition to the healthy nutrition program.

Dietary Supplement: Coconut

Control

NO INTERVENTION

Participants were given 4-week healthy nutrition training. Participants' basal metabolic rates were calculated according to gender and body weight (kg) using the Schofield equation. The appropriate equation 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 were provided. Total cholesterol of the nutrition program was kept at 300 mg and below. The control group was given only a healthy nutrition program.

Interventions

CoconutDIETARY_SUPPLEMENT

Participants in the intervention group, unlike participants in the control group, were asked to consume 50 g of fresh coconut daily for four weeks.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Physically disabled
  • Having problems with reading and comprehension
  • Have an existing diet program
  • Pregnant
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla sitki Kocman University

Muğla, Mentese, 48100, Turkey (Türkiye)

Location

Study Officials

  • Betul Uner Yilmaz, Lecturer

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 26, 2024

Study Start

February 1, 2018

Primary Completion

May 2, 2018

Study Completion

July 1, 2018

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations