Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-08-25

Brief Summary

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Obesity is a widespread disease that basically develops from unhealthy lifestyle and genetics. The Fat-mass and obesity associated (FTO) gene affects appetite and energy intake of the body, thus elevating fat mass and body weight. The single nucleotide polymorphism (SNP) rs9939609 of the FTO gene is a common variant in different ethnic groups, and its A allele is associated with increased body mass and waist circumference. Hence, the carriers of rs9939609 SNP are prone to weight gain if a healthy diet and lifestyle are not maintained. Similarly, high levels of serum cholesterol and triglycerides, while low levels of high-density lipoproteins are observed in carriers of rs9939609 AA genotype. For individuals having FTO rs9939609 A allele, consumption of hypocaloric diets (1500 kcal/day) consisting of high protein foods up to 25-30% of total daily energy intake might help reduce body weight. However, weight loss tends to vary in individuals after consuming the same diet under similar environmental conditions, so it is important to know the effect of different genotypes that might cause this variation. The study aimed to genotype overweight and obese adults for FTO rs9939609 polymorphism and to determine the effect of this polymorphism on body weight, BMI, waist and hip circumferences, lipid profile, insulin sensitivity, ghrelin levels, inflammatory markers and advanced glycation end-products in these individuals after consumption of a hypocaloric, high-protein diet for 4 weeks.

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Detailed Description

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Conditions

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Obesity Insulin Resistance Dyslipidemias Advance Glycation Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

It will be a quasi-experimental study, where 110 individuals with obesity will be allocated into three allele groups i.e. TT, AT and AA based on minor allele frequency. Each participant in the study will go through intervention of high protein, low calorie diet for four weeks.

BMI, waist to hip ratio, body composition, lipid profile, fasting glucose level, insulin resistance, advanced glycation end-products will measure at the start and end of the study while hunger hormone will be measured at the start, mid and end of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Protein Low Calorie Diet

3 meals/day consumed by the participants with daily caloric intake of 800 kcal. 40-60% of the total calories added from both animal and plant proteins. 30% of the total calories added from fats. 20% of the total calories added from carbohydrates.

Group Type EXPERIMENTAL

High Protein Low Calorie Dietary Intervention

Intervention Type OTHER

High Protein Diet: Diet consisting of 40-60% total energy from proteins, \<20% total energy from carbohydrates and \<30% total energy from fats.

Interventions

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High Protein Low Calorie Dietary Intervention

High Protein Diet: Diet consisting of 40-60% total energy from proteins, \<20% total energy from carbohydrates and \<30% total energy from fats.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1Overweight (BMI ≥ 25kg/m2) and obese (BMI ≥ 30kg/m2) individuals.
* Both genders.
* Age 18-50 years.

Exclusion Criteria

* Children, pregnant and lactating women
* Individuals taking medication for weight loss or undergoing any other weight loss dietary intervention.
* Individuals having lost more than 5 pounds in the past three-month period.
* Patients with any psychiatric disorders, heart, liver, kidney disease, diabetes or abnormal thyroid function.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes