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NCT06426017Completed

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

Source: ClinicalTrials.gov · Last updated 3 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
110 (actual)
First submitted
17 May 2024
Start date
1 May 2024
Primary completion date
25 Aug 2024
Lead sponsor
Khyber Medical University Peshawar
Diseases
Obesity
NCT number
NCT06426017

What you commit to

  • Study type: Interventional
  • Participants enrolled: 110
  • From 1 May 2024 to the primary completion date, 25 Aug 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals taking medication for weight loss or undergoing any other weight loss dietary intervention.

Other illness

  • Patients with any psychiatric disorders, heart, liver, kidney disease, diabetes or abnormal thyroid function.

Other

  • Children, pregnant and lactating women
  • Individuals having lost more than 5 pounds in the past three-month period.

Who the study is looking for

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

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Khyber Medical University
Coordinator of this site? Confirm its status
PeshawarPakistanUnknown status
Trial Room Institute of Basic Medical Sciences
Coordinator of this site? Confirm its status
PeshawarPakistanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.