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临床试验/NCT07750197
NCT07750197已完成不适用

Association of MC4R rs17782313 Polymorphism and Metabolic Phenotype With Responses to a 12-Week Combined Exercise and Dietary Intervention in Adult Men With Obesity

Harbin Sport University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change From Baseline in Body Weight at Week 12

研究概览

简要总结

This study evaluated whether differences in the MC4R rs17782313 gene variant and metabolic health status were associated with different responses to a 12-week exercise and dietary intervention in adult men with obesity.

A total of 40 men aged 18 to 59 years with obesity participated in the study. At baseline, participants were classified as having metabolically healthy obesity or metabolically unhealthy obesity according to metabolic risk factors. All participants received the same supervised lifestyle intervention, which included aerobic exercise, resistance training, and an individualized energy-controlled diet.

Body weight, body composition, physical fitness, blood pressure, blood glucose, blood lipids, glycated hemoglobin, and fasting insulin were measured before and after the 12-week intervention. Blood samples were also collected for MC4R rs17782313 genotyping. The study examined whether changes after the intervention differed according to baseline metabolic phenotype and MC4R genotype.

详细描述

This was a completed, single-center lifestyle intervention study involving adult men with obesity in Harbin, China.

Eligible participants were men aged 18 to 59 years with a body mass index of at least 28 kg/m2 and a waist circumference of at least 90 cm. At baseline, participants were classified as having metabolically healthy obesity or metabolically unhealthy obesity using criteria based on the National Cholesterol Education Program Adult Treatment Panel III.

Metabolically unhealthy obesity was defined as obesity accompanied by at least two of the following metabolic abnormalities: elevated blood pressure, elevated fasting blood glucose, elevated triglycerides, or reduced high-density lipoprotein cholesterol. Metabolically healthy obesity was defined as obesity accompanied by no more than one of these abnormalities.

All participants received the same 12-week supervised exercise and dietary intervention. The exercise program was conducted 5 days per week and consisted of aerobic exercise performed at approximately 60% to 70% of maximum heart rate and resistance exercise performed at approximately 40% to 60% of one-repetition maximum.

Daily energy intake was individualized according to standard body weight. The planned macronutrient distribution was approximately 50% to 60% of energy from carbohydrates, 15% to 20% from protein, and 20% to 30% from fat.

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 59 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 18 to 59 years
  • Body mass index of at least 28 kg/m2
  • Waist circumference of at least 90 cm
  • Able and willing to provide written informed consent
  • Able and willing to participate in the 12-week supervised exercise and dietary intervention and complete the scheduled assessments

排除标准

  • Severe hepatic insufficiency
  • Severe renal insufficiency
  • Cardiovascular disease
  • Other clinically significant vascular disease
  • Current use of glucose-lowering medication
  • Current use of antihypertensive medication
  • Current use of lipid-lowering medication
  • Unable or unwilling to comply with the intervention and assessment schedule

研究组 & 干预措施

Combined Exercise and Dietary Intervention

Experimental

All participants received the same 12-week supervised lifestyle intervention consisting of aerobic exercise, resistance training, and an individualized energy-controlled diet. Participants were subsequently classified according to baseline metabolic phenotype and MC4R rs17782313 genotype for subgroup analyses; these classifications did not determine intervention assignment.

干预措施: Supervised Aerobic and Resistance Exercise (Behavioral)

结局指标

主要结局

Change From Baseline in Body Weight at Week 12

时间窗: Baseline and Week 12

Body weight was measured in kilograms using a calibrated electronic scale, with participants wearing light clothing and no shoes. Change in body weight was calculated as the body weight measured at Week 12 minus the baseline body weight.

次要结局

未报告次要终点

研究者

发起方
Harbin Sport University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nijia Meng

Associate Professor

Harbin Sport University

研究点 (1)

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