Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06226623 |
| Other study ID # |
There is no sponsor support. |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2018 |
| Est. completion date |
July 1, 2018 |
Study information
| Verified date |
January 2024 |
| Source |
Mugla Sitki Koçman University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
The intervention program lasted 4 weeks. Face-to-face interviews lasting approximately 30
minutes were held with all participants every week. With these interviews, the compliance of
the intervention and control groups with the healthy nutrition program and coconut
consumption was evaluated. 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. Tanita brand SC 330 model bioelectric impedance
analyzer, which is frequently used in the literature, was preferred to determine the body
composition of individuals. In addition, height was measured using a portable height meter
that can measure between 14-200 cm, and waist circumference was measured using a standard
rigid tape measure. Body Mass Index (BMI) was calculated.
Tanita brand SC 330 model Bioelectrical Impedance Analysis (BIA) device, which has a
measurement accuracy of 0.1 kg, was used to determine body composition. With this device, the
body weights of individuals were measured, and a document calculating muscle and fat masses,
fat percentages and basal metabolic rates was obtained thanks to the 50 kHz electric current
it sent to the body. BIA is one of the anthropometric measurement methods. BIA analysis,
which is a quick and non-invasive method, is based on the principle that the resistance of
fat tissue to the electrical current passed through the body is different from other tissues;
It is a measurement method with high validity and reliability used to objectively calculate
body fat mass. In order to obtain the most accurate results with BIA measurements,
individuals should be measured with bare and dry feet three hours after getting up from bed,
twelve hours after going to the toilet, twelve hours after exercising, approximately three
hours after food consumption and excessive fluid intake, and before bathing, sauna and
swimming.
The height of the volunteers was measured barefoot using a portable height meter that can
measure between 14 and 200 cm on the Frankfort plane with an accuracy of 0.1 cm.
Waist circumference was measured at the midpoint between the last rib and the iliac bone with
the help of a rigid tape measure.
Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for
Windows, was used for statistical analysis. Statistical data are expressed as mean ± standard
deviation (X±SD), median or percentage (%). Whether the data showed normal distribution was
evaluated with the Kolmogorov-Smirnov test. The significance of the changes in body weight,
fat mass and percentage, waist circumference measurements and BMI values within the groups
was examined using the Wilcoxon T test. The intergroup significance of the change in body
composition of the individuals participating in the study was determined by the Mann Whitney
U test. In statistical analysis, the significance value within and between groups was taken
as p<0.05, and the difference between groups was taken as p<0.025.
