Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Dyslipidemias
Advance Glycation
Inflammation
Keywords: Satiety
Food Intake
High protein diet
Obesity
FTO rs9939609
Ghrelin
Carboxymethyl lysine
Interleukin-6
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body Composition
timeFrame: Day 0 and day 29
measure: Lipid Profile
timeFrame: Day 0 and day 29
measure: Waist Circumference
timeFrame: Day 0 and day 29
measure: Hip Circumference
timeFrame: Day 0 and day 29
measure: HOMA-IR
timeFrame: Day 0 and day 29
measure: Serum Carboxymethyl lysine levels (CML)
timeFrame: Day 0 and day 29
measure: Serum Interleukinin-6 (IL-6)
timeFrame: Day 0 and day 29
measure: Serum Hunger Hormone- Ghrelin
timeFrame: Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial).
measure: Body Mass Index (BMI)
timeFrame: Day 0 and day 29
measure: Waist-to-Hip Ratio (WHR)
timeFrame: Day 0 and Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Medical University
state: KPK
city: Peshawar
country: Pakistan
facility: Trial Room Institute of Basic Medical Sciences
state: KPK
Study officials:
References:
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citation: Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.
citation: Zou ZC, -J Mao L, Shi YY, Chen JH, Wang LS, Cai W. Effect of exercise combined with dietary intervention on obese children and adolescents associated with the FTO rs9939609 polymorphism. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4569-75.