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

NCT06426017 | Completed

• 1 other identifier: KMU/IBMS/IRBE/2023/1209-20
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Insulin Resistance; Dyslipidemias; Advance Glycation; Inflammation

Keywords

Satiety; Food Intake; High protein diet; Obesity; FTO rs9939609; Ghrelin; Carboxymethyl lysine; Interleukin-6

Outcome Measures

Primary Outcomes (10)

• Body Composition

  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.

  Day 0 and day 29

• Lipid Profile

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

  Day 0 and day 29

• Waist Circumference

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

  Day 0 and day 29

• Hip Circumference

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

  Day 0 and day 29

• HOMA-IR

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

  Day 0 and day 29

• Serum Carboxymethyl lysine levels (CML)

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

  Day 0 and day 29

• Serum Interleukinin-6 (IL-6)

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

  Day 0 and day 29

• Serum Hunger Hormone- Ghrelin

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

  Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial).

• Body Mass Index (BMI)

  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

  Day 0 and day 29

• Waist-to-Hip Ratio (WHR)

  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).

  Day 0 and Day 29

Study Arms (1)

High Protein Low Calorie Diet

EXPERIMENTAL

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.

Other: High Protein Low Calorie Dietary Intervention

Interventions

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.

High Protein Low Calorie Diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (2)

Khyber Medical University

Peshawar, KPK, 25100, Pakistan

Location

Trial Room Institute of Basic Medical Sciences

Peshawar, KPK, 25100, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 9846779 BACKGROUND

• 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.

  PMID: 17124223 BACKGROUND

• 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.

  PMID: 23867619 BACKGROUND

• 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.

  PMID: 26698254 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance; Dyslipidemias; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: May 1, 2024
• Primary Completion: August 25, 2024
• Study Completion: August 25, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)