AzTrials
AzTrials

ObesityNCT06426017

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

A study testing High Protein Low Calorie Dietary Intervention in people with Obesity and Insulin Resistance, run by Khyber Medical University Peshawar at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Insulin Resistance, Dyslipidemias
What is being tested?
High Protein Low Calorie Dietary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesPakistan
Study dates
1 May 2024to 25 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Khyber Medical University

    Peshawar, KPK, 25100

  • Trial Room Institute of Basic Medical Sciences

    Peshawar, KPK, 25100

Other trials in Pakistan

About this study

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.

Being tested
High Protein Low Calorie Dietary Intervention
Keywords
Satiety, Food Intake, High protein diet, Obesity, FTO rs9939609, Ghrelin, Carboxymethyl lysine, Interleukin-6
Medical subject headings
Obesity, Insulin Resistance, Dyslipidemias, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Protein Low Calorie Dietary InterventionOther

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

Study groups in NCT06426017
Study groupRoleWhat they receive
High Protein Low Calorie DietExperimental3 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.
Receives: Other: High Protein Low Calorie Dietary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0 and day 29

  2. Lipid Profile

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

    Measured: Day 0 and day 29

  3. Waist Circumference

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

    Measured: Day 0 and day 29

  4. Hip Circumference

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

    Measured: Day 0 and day 29

  5. HOMA-IR

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

    Measured: Day 0 and day 29

  6. 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.

    Measured: Day 0 and day 29

  7. Serum Interleukinin-6 (IL-6)

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

    Measured: Day 0 and day 29

  8. Serum Hunger Hormone- Ghrelin

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

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

  9. 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

    Measured: Day 0 and day 29

  10. 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).

    Measured: Day 0 and Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2024
  2. Study start1 May 2024
  3. Primary completion25 Aug 2024
  4. Study completion25 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06426017
Sponsor's protocol ID
KMU/IBMS/IRBE/2023/1209-20
Status last verified
Oct 2024
First submitted
17 May 2024
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9846779

  • 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.

    PubMed 17124223

  • 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.

    PubMed 23867619

  • 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.

    PubMed 26698254

Questions about this trial

What is this clinical trial studying?

A study testing High Protein Low Calorie Dietary Intervention in people with Obesity and Insulin Resistance, run by Khyber Medical University Peshawar at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Composition (time frame: Day 0 and day 29). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06426017, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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