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 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426017
• Other study ID #: ASRB001624/IF/IBMS
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 28, 2024

Study information

• Verified date: May 2024
• Source: Khyber Medical University Peshawar
• Contact: Dr Bibi Hajira, PhD
• Phone: 03015287833
• Email: ghanihajira[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 28, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Inflammation
• Insulin Resistance
• Obesity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Pakistan	Khyber Medical University	Peshawar	KPK
Pakistan	Trial Room Institute of Basic Medical Sciences	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

McMillan DC, Sattar N, McArdle CS. ABC of obesity. Obesity and cancer. BMJ. 2006 Nov 25;333(7578):1109-11. doi: 10.1136/bmj.39042.565035.BE1. No abstract available. — View Citation

Rexrode KM, Carey VJ, Hennekens CH, Walters EE, Colditz GA, Stampfer MJ, Willett WC, Manson JE. Abdominal adiposity and coronary heart disease in women. JAMA. 1998 Dec 2;280(21):1843-8. doi: 10.1001/jama.280.21.1843. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		Day 0 and day 29
Primary	Body Composition		Day 0 and day 29
Primary	Lipid Profile		Day 0 and day 29
Primary	Waist Circumference		Day 0 and day 29
Primary	Hip Circumference		Day 0 and day 29
Primary	HOMA-IR		Day 0 and day 29
Primary	Carboxymethyl lysine levels (CML		Day 0 and day 29
Primary	Interleukinin-6		Day 0 and day 29
Primary	Hunger Hormone- Ghrelin		Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial).