An interventional study of High Protein Low Calorie Dietary Intervention in Obesity, Insulin Resistance and Dyslipidemias, sponsored by Khyber Medical University Peshawar. Completed at 2 sites in Pakistan. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 110 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Khyber Medical University Peshawar is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
High Protein Diet: Diet consisting of 40-60% total energy from proteins, \<20% total energy from carbohydrates and \<30% total energy from fats.
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.
Time frame: 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.
Time frame: Day 0 and day 29
Waist Circumference
Waist circumference will measured in cm using a non-stretchable tape.
Time frame: Day 0 and day 29
Hip Circumference
Hip circumference will measured in cm using a non-stretchable tape.
Time frame: Day 0 and day 29
HOMA-IR
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) will be reported in pmol/L.
Time frame: 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.
Time frame: Day 0 and day 29
Serum Interleukinin-6 (IL-6)
Serum Interleukinin-6 (IL-6) will be used as marker of inflammation pg/mL.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Day 0 and Day 29
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Khyber Medical University Peshawar