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临床试验/NCT01050140
NCT01050140已完成不适用

The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men

University of Nottingham2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Liver triglyceride content

研究概览

简要总结

Dietary consumption of fructose has increased by nearly 50% since 1960.

A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP stores, systemic oxidative stress and cardiovascular status are not fully known.

详细描述

The protocol will assess the following outcomes:

  1. The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet
  2. The effect of a high fructose vs. glucose diet on liver ATP stores
  3. The effect of a high fructose vs. glucose diet on markers of oxidative stress
  4. The effect of a high fructose vs. glucose diet on cardiovascular status

Factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed.

32 centrally overweight healthy males with a low baseline fructose intake will be recruited. They will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days.

The sugars will first be taken in an energy balanced and then an overfeeding setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Body mass index 25-32
  • Waist > hip circumference
  • Age 18-50 years

排除标准

  • Reported weight change > 3 kg in prior 3/12
  • Active health problems
  • Contraindications to MRI scanning
  • Symptoms of functional bloating or irritable bowel syndrome
  • Abnormal liver or renal function tests
  • Random glucose greater than 11.0 mmol/L
  • Evidence of metabolic or viral liver disease as screened for by hepatitis B and C serology, and ferritin.
  • Alcohol intake > 21 units per week
  • Vegetarianism
  • Normal daily fructose intake from drinks greater than that in 500ml of coca cola
  • Abnormal carbohydrate energy contribution to baseline diet - defined as greater than 2 standard deviations from the mean of the National Diet and Nutrition Survey 2002 data

结局指标

主要结局

Liver triglyceride content

时间窗: 2 weeks

次要结局

  • Liver ATP, PME concentration and pH (31P MRS)(2 weeks)
  • Hepatic and systemic insulin resistance(2 weeks)
  • Cardiovascular measures using finometry(2 weeks)
  • Muscle triglyceride content(2 weeks)
  • Total abdominal visceral fat content (MRI)(2 weeks)
  • Liver de novo lipogenesis(2 weeks)
  • Resting energy expenditure, lipid and carbohydrate oxidation rates(2 weeks)
  • Systemic oxidative stress and inflammatory cytokine profile(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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