NCT04662411已完成不适用
Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plasma butyrate concentrations
研究概览
简要总结
In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese men (BMI ≥ 25 kg/m2 and ≤ 34.9 kg/m2);
- •Aged 40 - 70 years;
- •Caucasian;
- •Normal blood pressure (systolic blood pressure 100-140mmHg, diastolic blood pressure 60-90 mmHg);
- •Weight stable for at least 3 months (± 2 kg).
排除标准
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L)
- •Gastroenterological diseases or abdominal surgery (gallbladder removal and appendix removal are allowed)
- •Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- •Lactose intolerance or other disorders that affect digestion (such as celiac disease)
- •Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day; and excessive alcohol use defined as (> 15 units/week)
- •Plans to lose weight or following of a hypocaloric diet in the following three months;
- •Regular supplementation of pre- or probiotic products (for example Yakult, Activia), use of pre- or probiotics 3 months prior to the start of the study;
- •Intensive exercise training more than three hours a week;
- •Use of any medication that influences glucose or fat metabolism and inflammation (i.e. betablockers, corticosteroids, statins or NSAIDs);
- •Regular use of laxation products in 3 months prior start of study or during study period;
- •Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- •Follow a vegan diet or vegetarian diet.
研究组 & 干预措施
butyrate and hexanoate amount 1
Experimental
1325 mg of butyrate and hexanoate
干预措施: butyrate and hexanoate amount 1 (Dietary Supplement)
butyrate and hexanoate amount 2
Experimental
干预措施: butyrate and hexanoate amount 2 (Dietary Supplement)
butyrate and hexanoate amount 3
Experimental
干预措施: butyrate and hexanoate amount 3 (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Plasma butyrate concentrations
时间窗: Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement
Plasma butyrate concentrations
次要结局
- Circulating insulin(Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement)
- Breath H2(Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement)
- Circulating Free Fatty Acids(Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement)
- Circulating Glycerol(Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement)
- Circulating Glucose(Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement)
- Circulating Triglycerides (TG)(Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement)
研究者
研究点 (1)
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