Obese WomenNCT06442202
Balanced Nutritional Diet Intervention Among Obese Women
A study testing Balanced Nutritional Diet and Nutritional Education in people with Obese Women, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Obese Women
- What is being tested?
- Balanced Nutritional Diet and Nutritional Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Nov 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Being pregnant and breastfeeding
- Had a history of chronic disease
- Regularly consuming antioxidant supplements and/or phytopharmaceuticals
- Currently participating in other research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balanced Nutritional Diet Intervention on Body Composition Among Different FTO RS9939609 Gene in Obese Young Women In Bandung, Indonesia: A Randomised Controlled Trial
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.
Read the detailed description
A Balanced Nutrition Diet is a group of food menus that contain carbohydrates, fats, proteins, vitamins and minerals which are prepared based on the principles of diversity, balanced, regular and safe proportions in types and quantities that suit the body's needs adapted from the My Meal Dish Content/"Isi Piringku"; and "Tumpeng Gizi Seimbang" rule based on the Balanced Nutrition Guidelines of the Republic of Indonesia Minister of Health Regulation No. 41 year 2014. Although a balanced nutritional diet has not been widely used as a dietary intervention for obese people compared to the Mediterranean diet, there is research that shows that providing a low-calorie balanced nutritional diet based on traditional Indonesian food for 8 weeks can reduce body weight and body mass index, waist circumference, and body fat percentage of the research subjects were statistically significant.
Apart from eating habits, genetic factors also play an important role in the development of obesity. One of the most important genes associated with obesity is the FTO (fat mass and obesity-related) gene located on chromosome 16. Several polymorphisms in the FTO gene are known to be associated with increased body mass index (BMI) and other anthropometric values, severe obesity conditions, and risk of diabetes mellitus, although there are differences in different ethnicities. Several studies have also examined the association of the FTO gene with several parameters related to cardiovascular risk. The FTO rs9939609 gene polymorphism is one of the genes commonly studied in relation to obesity. The rs9939609 FTO gene consists of TT, TA, and AA genotypes. Allele A is a group of mutant genotypes or is called a risk allele (TA and AA) while TT is a group of wild genotypes or is considered a non-risk allele.
Evidence suggests that compared with TT wild type, the risk allele A FTO rs9939609 gene showed significantly higher body weight, body mass index, waist circumference, hip circumference, and waist-to-hip ratio. The waist-hip circumference ratio is a stronger indicator of cardiovascular disease than body mass index. The A allele carriers of the FTO rs9939609 polymorphism had a higher fat percentage. Until now, no one has ever linked the FTO gene polymorphism and the Balanced Nutrition Diet intervention, which is a reference in Indonesia, as well as its effect on the body composition of obese young women, especially in Sundanese ethnicity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among 2 types of the FTO rs9939609 gene in obese young women in Bandung City, Indonesia.
- Conditions
- Obese Women
- Being tested
- Balanced Nutritional Diet, Nutritional Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced Nutritional DietDietary 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.
Nutritional EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Nutritional Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start8 Nov 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prodi Gizi, Principal investigator, Institut Pertanian Bogor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442202
- Sponsor's protocol ID
- IPB-202405.01
- Status last verified
- Jun 2024
- First submitted
- 16 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Nutritional Diet Intervention on Body Composition Among Different FTO RS9939609 Gene in Obese Young Women In Bandung, Indonesia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06442202
- Acronym / sponsor ID
- IPB-202405.01
- Conditions
- Obese Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Balanced Nutrition Diet is a group of food menus that contain carbohydrates, fats, proteins, vitamins and minerals which are prepared based on the principles of diversity, balanced, regular and safe proportions in types and quantities that suit the body's needs adapted from the My Meal Dish Content/"Isi Piringku"; and "Tumpeng Gizi Seimbang" rule based on the Balanced Nutrition Guidelines of the Republic of Indonesia Minister of Health Regulation No. 41 year 2014. Although a balanced nutritional diet has not been widely used as a dietary intervention for obese people compared to the Mediterranean diet, there is research that shows that providing a low-calorie balanced nutritional diet based on traditional Indonesian food for 8 weeks can reduce body weight and body mass index, waist circumference, and body fat percentage of the research subjects were statistically significant.
Apart from eating habits, genetic factors also play an important role in the development of obesity. One of the most important genes associated with obesity is the FTO (fat mass and obesity-related) gene located on chromosome 16. Several polymorphisms in the FTO gene are known to be associated with increased body mass index (BMI) and other anthropometric values, severe obesity conditions, and risk of diabetes mellitus, although there are differences in different ethnicities. Several studies have also examined the association of the FTO gene with several parameters related to cardiovascular risk. The FTO rs9939609 gene polymorphism is one of the genes commonly studied in relation to obesity. The rs9939609 FTO gene consists of TT, TA, and AA genotypes. Allele A is a group of mutant genotypes or is called a risk allele (TA and AA) while TT is a group of wild genotypes or is considered a non-risk allele.
Evidence suggests that compared with TT wild type, the risk allele A FTO rs9939609 gene showed significantly higher body weight, body mass index, waist circumference, hip circumference, and waist-to-hip ratio. The waist-hip circumference ratio is a stronger indicator of cardiovascular disease than body mass index. The A allele carriers of the FTO rs9939609 polymorphism had a higher fat percentage. Until now, no one has ever linked the FTO gene polymorphism and the Balanced Nutrition Diet intervention, which is a reference in Indonesia, as well as its effect on the body composition of obese young women, especially in Sundanese ethnicity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among 2 types of the FTO rs9939609 gene in obese young women in Bandung City, Indonesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Allele A + Diet Intervention | Experimental | Dietary Supplement: Balanced Nutritional Diet, Behavioral: Nutritional EducationSubjects 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. |
| T Homozygote + Diet Intervention | Experimental | Dietary Supplement: Balanced Nutritional Diet, Behavioral: Nutritional EducationSubjects 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. |
| Allele A Control | Placebo comparator | Behavioral: Nutritional EducationSubjects 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. |
| T Homozygote Control | Placebo comparator | Behavioral: Nutritional EducationSubjects 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Being pregnant and breastfeeding
- Had a history of chronic disease
- Regularly consuming antioxidant supplements and/or phytopharmaceuticals
- Currently participating in other research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced Nutritional DietFood 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. | Dietary supplement | Allele A + Diet Intervention, T Homozygote + Diet Intervention |
| Nutritional EducationNutritional 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. | Behavioural | Allele A + Diet Intervention, Allele A Control, T Homozygote + Diet Intervention, T Homozygote Control |
Primary outcome
Change of Body Compostition
Time frame: 28 days
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 (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prodi Gizi principal investigator
Institut Pertanian Bogor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced Nutritional Diet and Nutritional Education in people with Obese Women, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Body Compostition (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.