Dietary Methionine and Cysteine Restriction in Overweight Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in plasma concentrations of amino acids
研究概览
简要总结
The aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects
详细描述
The sulfur-containing amino acid methionine and its downstream metabolite cysteine has been associated with fat mass in animal studies and human observational studies. Some of the proposed mechanisms include an association with lipogenesis, insulin sensitivity and disrupted energy metabolism.
The overall aim of this project is to evaluate the effects of a diet low in methionine and cysteine on markers of lipids, amino acids, glucose and other biomarkers related to energy metabolism, including transcriptomic and protein expression data from adipose tissue and lymphocytes. Overweight and obese but otherwise healthy volunteers will be randomized to receive a diet either low, moderate or high in methionine and cysteine concentrations for 1 week.
This is a pilot study that may be considered an extension of NCT02647970. In addition to the primary and secondary outcomes we will evaluate the feasibility of the intervention and procedures.
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
- Double (Participant, Investigator)
盲法说明
Participant: The diets are similar except for methionine and cysteine, and it is thought that the participants will not be able to identify their treatment allocation by taste.
Investigator: Randomization will be carried out by an investigator that is not related to the study. All foods will be pre-packaged and delivered to the participants by an unrelated company.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 25-35 kg/m2
排除标准
- •High physical activity
- •Chronic disease
- •Pregnancy or breastfeeding
结局指标
主要结局
Change in plasma concentrations of amino acids
时间窗: Baseline, Day 1, Day 3 and Day 7 (final visit)
Measurement of biomarkers of amino acid metabolism, including plasma concentrations of methionine, cysteine and related metabolites
Change in protein expression activity in tissues
时间窗: Baseline and day 7 (final visit for adipose tissue, Baseline and day 1, 3 and 7 (final visit) for lymphocytes.
Measurement of protein expression and activity related to methionine and cysteine metabolism in adipose tissue and lymphocytes.
次要结局
- Change in plasma activity indices of steaoryl-CoA desaturase(Baseline, Day 1, Day 3 and Day 7 (final visit))
- Change in protein expression of steaoryl CoA-desaturase in adipose tissue(Baseline and Day 7 (final visit))
- Change in plasma concentrations of fatty acids(Baseline, Day 1, Day 3 and Day 7 (final visit))
- Change in protein expression of steaoryl CoA-desaturase in lymphocytes(Baseline, Day 1, Day 3 and Day 7 (final visit))
- Change in steaoryl CoA-desaturase activity in adipose tissue(Baseline and Day 7 (final visit))
- Diet feasibility(Baseline, Day 1, Day 3 and Day 7 (final visit))
- Diet compliance(Baseline, Day 1, Day 3 and Day 7 (final visit))
- Body composition(Baseline and day 7 (final visit))
研究者
Kathrine Vinknes
Kathrine Vinknes, PhD
University of Oslo