## Protocol Section
### Identification Module
**NCT ID:** NCT06426017

**Brief 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

**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

#### Organization Study ID Info
**ID:** ASRB001624/IF/IBMS
#### Organization
**Class:** OTHER
**Full Name:** Khyber Medical University Peshawar
### Status Module
#### Completion Date
**Date:** 2024-07-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Khyber Medical University Peshawar

#### Responsible Party

**Investigator Affiliation:** Khyber Medical University Peshawar

**Investigator Full Name:** Bibi Hajira

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Obesity

- Insulin Resistance

- Dyslipidemias

- Advance Glycation

- Inflammation

**Keywords:**

- Satiety

- Food Intake

- High protein diet

- Obesity

- FTO rs9939609

- Ghrelin

- Carboxymethyl lysine

- Interleukin-6

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 110

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: High Protein Low Calorie Dietary Intervention

**Label:** High Protein Low Calorie Diet

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High Protein Low Calorie Diet

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

**Name:** High Protein Low Calorie Dietary Intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Body Weight

**Time Frame:** Day 0 and day 29

**Measure:** Body Composition

**Time Frame:** Day 0 and day 29

**Measure:** Lipid Profile

**Time Frame:** Day 0 and day 29

**Measure:** Waist Circumference

**Time Frame:** Day 0 and day 29

**Measure:** Hip Circumference

**Time Frame:** Day 0 and day 29

**Measure:** HOMA-IR

**Time Frame:** Day 0 and day 29

**Measure:** Carboxymethyl lysine levels (CML

**Time Frame:** Day 0 and day 29

**Measure:** Interleukinin-6

**Time Frame:** Day 0 and day 29

**Measure:** Hunger Hormone- Ghrelin

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

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ghanihajira@gmail.com

**Name:** Dr Bibi Hajira, PhD

**Phone:** 03015287833

**Role:** CONTACT

**Contact 2:**

**Email:** omarmalik786@gmail.com

**Name:** Dr Muhammad Omar Malik, PhD

**Phone:** 03335196243

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Peshawar

**Contacts:**

***Contact 1:***

- **Email:** ghanihajira@gmail.com

- **Name:** Bibi Hajira, PhD

- **Phone:** 0301-5287833

- **Role:** CONTACT

***Contact 2:***

- **Email:** omarmalik786@gmail.com

- **Name:** Omar Malik, PhD

- **Phone:** 0333-5196243

- **Role:** CONTACT

***Contact 3:***

- **Name:** Bibi Hajira, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Omar Malik, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Pakistan

**Facility:** Khyber Medical University

**State:** KPK

**Status:** RECRUITING

**Zip:** 25100

**Location 2:**

**City:** Peshawar

**Contacts:**

***Contact 1:***

- **Email:** ghanihajira@gmail.com

- **Name:** Dr Bibi Hajira, PhD

- **Phone:** 03015287833

- **Role:** CONTACT

***Contact 2:***

- **Email:** omarmalik786@gmail.com

- **Name:** Dr Muhammad Omar Malik, PhD

- **Phone:** 03335196243

- **Role:** CONTACT

***Contact 3:***

- **Name:** Dr Bibi Hajira, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Dr Muhammad Omar, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Pakistan

**Facility:** Trial Room Institute of Basic Medical Sciences

**State:** KPK

**Status:** RECRUITING

**Zip:** 25100

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 9846779

**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.

**PMID:** 17124223

**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.

**PMID:** 23867619

**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.

**PMID:** 26698254

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000052439

- Term: Lipid Metabolism Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M10370

- Name: Insulin Resistance

- Relevance: HIGH

- As Found: Insulin Resistance

- ID: M26181

- Name: Dyslipidemias

- Relevance: HIGH

- As Found: Dyslipidemia

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007333

- Term: Insulin Resistance

- ID: D000050171

- Term: Dyslipidemias

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: T11

- Name: Lysine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
