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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Body Composition
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1Overweight (BMI ≥ 25kg/m2) and obese (BMI ≥ 30kg/m2) individuals.
- •Both genders.
- •Age 18-50 years.
排除标准
- •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.
结局指标
主要结局
Body Composition
时间窗: Day 0 and day 29
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.
Lipid Profile
时间窗: Day 0 and day 29
Lipid profile will include concentration of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides in blood and measured in mg/dl.
Waist Circumference
时间窗: Day 0 and day 29
Waist circumference will measured in cm using a non-stretchable tape.
Hip Circumference
时间窗: Day 0 and day 29
Hip circumference will measured in cm using a non-stretchable tape.
HOMA-IR
时间窗: Day 0 and day 29
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) will be reported in pmol/L.
Serum Carboxymethyl lysine levels (CML)
时间窗: Day 0 and day 29
Sreum concentration of Carboxymethyl lysine (CML) will be used an advanced glycation endproduct (AGE) marker and expressed in ng/mL.
Serum Interleukinin-6 (IL-6)
时间窗: Day 0 and day 29
Serum Interleukinin-6 (IL-6) will be used as marker of inflammation pg/mL.
Serum Hunger Hormone- Ghrelin
时间窗: Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial).
Serum Hunger Hormone- Ghrelin will be used to asses satiety related sensation and expressed as pmol/l.
Waist-to-Hip Ratio (WHR)
时间窗: Day 0 and Day 29
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).
Body Mass Index (BMI)
时间窗: Day 0 and day 29
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
次要结局
未报告次要终点
研究者
Bibi Hajira
Assistant Professor
Khyber Medical University Peshawar