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临床试验/CTRI/2018/12/016777
CTRI/2018/12/016777招募中不适用

Effect of protein supplementation on amino acid profile and skeletal muscle health among healthy Indian adults

Nutricia International Pvt Ltd1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年12月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
1. To study the acute effect of (12g) protein consumption on the changes in amino acid pool (through amino-acidomics) and skeletal muscle health (strength, endurance and fatigability) among healthy Indian adults.

研究概览

简要总结

Protein ingestion (source, dose, timing, and pattern) is a key stimulus for preserving skeletal muscle mass and strength. Inadequate protein intake causes an imbalance in protein metabolism in skeletal muscle health. This in turn could lead into loss in muscle mass and strength. Understanding the role of adequate protein intake and its impact on  muscle health is important among Indian population, as majority of the population consume cereal based diet. With ageing changes in muscle health has been reported. The consequence of loss of muscle mass and strength with ageing will lead to reduced physical activity further causing chronic diseases. One of the ways it can be delayed is by providing adequate nutrition and exercise during middle age. So overall goal of the study is to increase our understanding of the role of protein supplementation and simple exercise like brisk walking among Indians on muscle health (muscle mass and strength).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Healthy controls BMI: 18.5- 24.9 kg/m2 Muscle strength < 1 SD from Indian data set.

排除标准

  • H/O chronic diseases (Prediabetes, Type 2 DM, Hypertension, tuberculosis, cancer, chronic renal failure, ischemic heart disease, infections[tuberculosis, typhoid, dengue, etc.
  • in the last 3 months etc)
  • H/O allergy to any form of protein intake (ex: soy)
  • Lactose intolerance
  • Alcohol intake greater than 2 STD per day
  • Any form of anaemia
  • Any form of peripheral neuropathy
  • Muscular dystrophies
  • Any form of surgeries on knee and wrist
  • History of osteoarthritis
  • Pregnancy
  • Consumption of protein supplements/nutritional supplement or Excess intake of protein than recommended
  • Those who exercise regularly (any form of resistance exercise/ heavy exercise, etc.).

结局指标

主要结局

1. To study the acute effect of (12g) protein consumption on the changes in amino acid pool (through amino-acidomics) and skeletal muscle health (strength, endurance and fatigability) among healthy Indian adults.

时间窗: 1.Acute study- Baseline, Day 7 | 2. Chronic study- Baseline, end of 8th week

2. To study the combined effect of 8 week protein supplementation and aerobic exercise (150 min brisk walking) on the changes in skeletal muscle health and amino acid pool among healthy Indian adults.

时间窗: 1.Acute study- Baseline, Day 7 | 2. Chronic study- Baseline, end of 8th week

次要结局

  • To study the combined effect of 8 week protein supplementation and aerobic exercise (150 min brisk walking) on the changes in skeletal muscle health and amino acid pool among healthy Indian adults.(Chronic study- Baseline, end of 8th week)

研究者

发起方
Nutricia International Pvt Ltd
申办方类型
Other [Nutraceutical company]

研究点 (1)

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