Balanced Nutritional Diet Intervention Among Obese Women

NCT06442202 | Completed DMC

• 1 other identifier: IPB-202405.01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Food intake along with the gene are important factors that influence human nutrition status and health. Indonesia has a balanced nutrition diet guide for ideal food consumption. The FTO rs9939609 gene is known to be related to obesity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among different single nucleotide polymorphisms (SNP) of the FTO rs9939609 gene in obese young women in Bandung City, West Java, Indonesia.

Conditions

Obese Women

Outcome Measures

Primary Outcomes (1)

• Change of Body Compostition

  Body composition will be measured twice, i.e. before randomization and 28 days after randomization. The measurement include body weight (kg); body height (cm); Body Mass Index (kg/m2); Waist circumference (cm); Hip circumference (cm); Waist-hip ratio; Visceral fat; Fat percentage (%); Resting metabolism (Cal); Total subcutaneous fat (%); Subcutaneous trunk (%); Subcutaneous arms (%); Subcutaneous legs (%); Total skeletal muscle (%); Skeletal trunk (%); Skeletal arms (%); Skeletal legs (%)

  28 days

Study Arms (4)

Allele A + Diet Intervention

EXPERIMENTAL

Subjects with allele A carriers (AA/AT) FTO rs9939609 gene type, took a Balanced Nutritional Diet Intervention for 28 days. Besides, this group received nutritional education. Twelve (12) subjects were included in this group.

Dietary Supplement: Balanced Nutritional Diet; Behavioral: Nutritional Education

T Homozygote + Diet Intervention

EXPERIMENTAL

Subjects with T homozygote FTO rs9939609 gene type, took a Balanced Nutritional Diet Intervention for 28 days. Besides, this group received nutritional education. Eight (8) subjects were included in this group.

Dietary Supplement: Balanced Nutritional Diet; Behavioral: Nutritional Education

Allele A Control

PLACEBO COMPARATOR

Subjects with allele A carriers (AA/AT) FTO rs9939609 gene type, control group, eat ad libitum. This group also received nutritional education. Ten (10) subjects were included in this group.

Behavioral: Nutritional Education

T Homozygote Control

PLACEBO COMPARATOR

Subjects with T Homogyzot FTO rs9939609 gene type, control group, eat ad libitum. This group also received nutritional education. Eight (8) subjects were included in this group.

Behavioral: Nutritional Education

Interventions

Balanced Nutritional Diet DIETARY_SUPPLEMENT

Food was provided during the intervention period 3 (three) times each day, i.e. breakfast, lunch and dinner. The food menu used a 30-day menu cycle. The characteristics of the Balanced Nutrition Diet that have been provided based on the distribution of the composition of the macronutrients that will be intervened in are as follows: 45-55% carbohydrates, 15-20% protein, and 20-25% fat (Ministry of Health 2014). The type of diet and portions that were given were the same for each menu unless there were certain food restrictions or allergies, and then the type of food was adjusted specifically to that individual. The calories that will be given range from 300-400 Cal for breakfast, 400-500 Cal for lunch, and 300-500 Cal for dinner. The choice of carbohydrates should be varied and prioritise complex carbohydrates such as whole grains. The choice of protein type is prioritised from low-fat protein sources and half of it is vegetable protein.

Allele A + Diet Intervention; T Homozygote + Diet Intervention

Nutritional Education BEHAVIORAL

Nutritional education is provided via online Zoom meetings with the help of educational media in the form of PowerPoint presentations/videos before entering the intervention period. The educational material that will be provided is regarding Guidelines for Balanced Nutrition, Food Safety, and Healthy Lifestyles (stress management and sleep time). The subject's understanding of the material provided was evaluated using an online quiz platform.

Allele A + Diet Intervention; Allele A Control; T Homozygote + Diet Intervention; T Homozygote Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese women (fat percentage\>35%) who had light to moderate physical activity based on PAL or who rarely exercised
• Sundanese ethnicity
• Aged 18-25 years
• Normal fasting blood glucose levels
• Willing to participate and sign an informed consent

You may not qualify if:

• Being pregnant and breastfeeding
• Had a history of chronic disease
• Regularly consuming antioxidant supplements and/or phytopharmaceuticals
• Currently participating in other research

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Prodi Gizi IPB

Bogor, Indonesia

Location

Study Officials

• Prodi Gizi

  Institut Pertanian Bogor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 4, 2024
• Study Start: November 8, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

ID (1)