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临床试验/NCT04701346
NCT04701346已完成不适用

Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity

University of Oslo2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Changes in body weight

研究概览

简要总结

The primary objective of the trial is to establish the effects of dietary sulfur amino acid (SAA) restriction on body weight, body composition and energy expenditure in humans.

详细描述

Dietary SAA restriction is an established model for increasing lifespan and improving metabolic health in animal studies. Data from human studies are limited.

In this study the investigators will perform an 8-week dietary intervention with SAA restriction to characterise the effects on several parameters related to metabolic health including body weight, body composition, energy expenditure, lipid profile and gene expression profiles in adipose tissue. The aim is to translate findings from previous animal experiments to humans

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy participants with overweight and obesity (BMI 27-35 kg/m2)
  • Waist circumference > 80 cm for women and > 94 cm for men

排除标准

  • Presence of chronic disease
  • Established co-morbidities
  • Already on a vegan diet or have been the last month
  • Pregnancy
  • Breastfeeding the last 3 months
  • Unstable body weight the last 3 months
  • High intensity training > 3 times weekly

结局指标

主要结局

Changes in body weight

时间窗: At baseline, 4 and 8 weeks

Kilograms

次要结局

  • Changes in resting energy expenditure(At baseline, 4 and 8 weeks)
  • Changes in plasma concentrations of SAA and related intermediates and compounds(At baseline, 4 and 8 weeks)
  • Changes in concentrations of plasma lipid profile(At baseline, 4 and 8 weeks)
  • Changes in plasma concentrations of adipokines and appetite hormones(At baseline, 4 and 8 weeks)
  • Changes in fibroblast growth factor 21 (FGF21)(At baseline, 4 and 8 weeks)
  • Changes in gut microbiota(At baseline, 4 and 8 weeks)
  • Changes in body composition(At baseline, 4 and 8 weeks)
  • Changes in substrate oxidation(At baseline, 4 and 8 weeks)
  • Changes in urine concentrations of SAA and related intermediates and compounds(At baseline, 4 and 8 weeks)
  • Changes in plasma makers of insulin sensitivity(At baseline, 4 and 8 weeks)
  • Changes in biomarkers related to obesity and energy metabolism(At baseline, 4 and 8 weeks)
  • Changes in gene expression(At baseline, 4 and 8 weeks)
  • Vitamin status(At baseline, 4 and 8 weeks)
  • Changes in short chain fatty acids(At baseline, 4 and 8 weeks)
  • Nitrogen balance(At baseline, 4 and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathrine Vinknes

Researcher

University of Oslo

研究点 (2)

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