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临床试验/NCT07550023
NCT07550023招募中不适用

Effects Of Dietary Fats on Gut Microbiota Composition and Metabolic Activity in Healthy Adults

University of Glasgow1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Change in faecal short-chain fatty acid (SCFA) concentrations

研究概览

简要总结

This study will investigate how adding a specific type of dietary fat to daily meals for two weeks affects the gut bacteria and their activity. Participants will be randomly assigned to consume one of four types of fat: butter, coconut oil, olive oil, or sunflower oil (60 mL each day for 2 weeks). Stool and blood samples (after an overnight fast) will be collected at 3 time points during the study (Days 1, 7, and 22). These samples will be used to measure metabolites produced by gut bacteria, the types of bacteria present in the gut, blood lipids, and inflammatory markers. The study, based on previous in vitro findings, aims to understand whether different types of fats (based on their structure and level of saturation) have different effects on gut bacteria and their activity in healthy subjects.

详细描述

This is a pilot, parallel, randomised controlled dietary intervention trial investigating the effects of dietary fat composition on gut microbiota and metabolic activity in healthy adults. Participants will be randomised to one of four intervention groups (butter, coconut oil, extra virgin olive oil, or sunflower oil), representing commonly consumed dietary fats that differ in fatty acid structure.

This study builds on prior in vitro findings demonstrating that fatty acid chain length and degree of saturation influence microbial fermentation pathways and short-chain fatty acid (SCFA) production.

The primary objective is to determine whether structurally distinct dietary fats differentially influence gut microbial activity and composition in vivo. Secondary objectives include assessing the effects on cardiometabolic and inflammatory markers. It is hypothesised that dietary fats differing in chain length and degree of saturation will differentially modulate gut microbiota metabolism, with potential systemic effects on circulating cardiometabolic and inflammatory markers.

A total of 64 healthy adults aged 20-50 years will be recruited from the Glasgow area. All study visits will take place at the New Lister Building, University of Glasgow. Participants will attend three study visits over a three-week period.

The study includes a one-week run-in period (normal habitual diet) followed by a two-week dietary intervention. During the intervention, participants will replace the majority of their habitual dietary fat intake with their allocated fat while maintaining their usual diet and lifestyle.

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
None

入排标准

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

入选标准

  • Adults aged 20-50 years
  • Body mass index (BMI) between 20 and 30 kg/m²
  • Generally healthy
  • Stable body weight (±2 kg) over the past 2 months
  • Living in the Glasgow area
  • Non-smoker

排除标准

  • Use of antibiotics within the past 3 months
  • Current use of medications affecting gut microbiota or cardiometabolic health
  • Regular use of dietary supplements that may influence study outcomes (e.g. probiotics, prebiotics, vitamins, minerals, fish oil), unless willing to discontinue prior to study start
  • Presence of chronic gastrointestinal, metabolic, cardiovascular, hepatobiliary, or pancreatic disease
  • History of major gastrointestinal surgery
  • Diagnosed diabetes or use of lipid-lowering therapy
  • Known fat malabsorption disorders
  • Pregnant or lactating women
  • Post-menopausal women
  • Following a restrictive or specific diet (e.g. vegan, ketogenic diet)
  • Food allergies or intolerances relevant to study interventions (e.g. dairy, coconut)
  • Recent significant weight change (±2 kg in the past month)
  • High reliance on ready meals or takeaway foods (>7 main meals per week)
  • Participation in another research study that may interfere with this study

研究组 & 干预措施

Butter

Experimental

Following a one week run-in period (habitual diet), participants will be assigned to consume butter as their primary dietary fat.

干预措施: Butter (Other)

Coconut Oil

Experimental

Following a one week run-in period (habitual diet), participants will be assigned to consume coconut oil as their primary dietary fat.

干预措施: Coconut oil (Other)

Extra Virgin Olive Oil

Experimental

Following a one week run-in period (habitual diet), participants will be assigned to consume olive oil as their primary dietary fat.

干预措施: Extra Virgin Olive Oil (Other)

Sunflower Oil

Experimental

Following a one week run-in period (habitual diet), participants will be assigned to consume sunflower oil as their primary dietary fat.

干预措施: Sunflower Oil (Other)

结局指标

主要结局

Change in faecal short-chain fatty acid (SCFA) concentrations

时间窗: Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention)

Faecal concentrations of short-chain fatty acids (acetate, propionate, and butyrate) will be measured using gas chromatography to assess changes in gut microbial metabolic activity in response to dietary fat intervention.

Change in gut microbiota composition

时间窗: Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention)

Gut microbiota composition will be assessed using 16S rRNA gene amplicon sequencing to evaluate changes in bacterial diversity and relative abundance following the dietary fat intervention.

次要结局

  • Change in blood lipid profile(Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention))
  • Change in inflammatory markers(Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention))
  • Change in faecal pH(Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention))
  • Change in fasting glucose concentrations(Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention))
  • Change in faecal fat content(Day 1 (pre run-in), Day 7 (baseline, post run-in), and Day 22 (post-intervention))

研究者

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

Athanasios Koutsos

Lecturer in Human Nutrition

University of Glasgow

研究点 (1)

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