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Completed

NCT Number: NCT06426017

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

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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Key information

Conditions

Obesity Advance Glycation Body Weight Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Medical University, Peshawar, KPK, Pakistan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Protein Low Calorie Dietary Intervention

Other

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

Primary outcomes

  1. Body Composition

    Time frame: Day 0 and day 29

    Body composition will be measured using Bioimpedance scale which will include percent body fatness, muscle mass, total body water, bone mass and body protein status.

  2. Lipid Profile

    Time frame: Day 0 and day 29

    Lipid profile will include concentration of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides in blood and measured in mg/dl.

  3. Waist Circumference

    Time frame: Day 0 and day 29

    Waist circumference will measured in cm using a non-stretchable tape.

  4. Hip Circumference

    Time frame: Day 0 and day 29

    Hip circumference will measured in cm using a non-stretchable tape.

  5. HOMA-IR

    Time frame: Day 0 and day 29

    HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) will be reported in pmol/L.

  6. Serum Carboxymethyl lysine levels (CML)

    Time frame: Day 0 and day 29

    Sreum concentration of Carboxymethyl lysine (CML) will be used an advanced glycation endproduct (AGE) marker and expressed in ng/mL.

  7. Serum Interleukinin-6 (IL-6)

    Time frame: Day 0 and day 29

    Serum Interleukinin-6 (IL-6) will be used as marker of inflammation pg/mL.

  8. Serum Hunger Hormone- Ghrelin

    Time frame: Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial).

    Serum Hunger Hormone- Ghrelin will be used to asses satiety related sensation and expressed as pmol/l.

  9. Body Mass Index (BMI)

    Time frame: Day 0 and day 29

    Body weight will be measured in Kg. Height will be measure in cm. Weight and height will be used to calculate body mass index (BMI) to report in Kg/m^2

  10. Waist-to-Hip Ratio (WHR)

    Time frame: Day 0 and Day 29

    Waist and Hip Circumference will be measured in cm. These two measures will be used to calculate waist-to-hip ratio (WHR) as waist measurement divided by hip measurement (W⁄H).

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 23, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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