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RecruitingNCT07550023Updated Apr 24, 2026

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

An interventional study of Butter and Coconut oil in Short Chain Fatty Acids Concentration in Stools, Gut Microbiota Diversity and Composition and Blood Lipid Profiles, sponsored by University of Glasgow. Recruiting at 1 site in United Kingdom. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by University of Glasgow · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

Biological samples (blood and stool) will be collected at each study visit (Day 1, 7 and 22) to assess study outcomes. Anthropometric measurements will also be recorded. Dietary intake, gastrointestinal symptoms, and compliance will be monitored using food diaries, symptom questionnaires, and adherence logs.

The sample size is based on anticipated changes in faecal SCFA concentrations. Based on prior data, 14 participants per group provides 80% power (P=0.05) to detect a mean change of 30 μmol/g (SD: 28 μmol/g). Allowing for a 10% drop-out rate, 16 participants per group (64 total) will be recruited. As this is a pilot study, this calculation is intended to inform a reasonable sample size rather than to ensure definitive hypothesis testing.

02

Conditions studied

  • Short Chain Fatty Acids Concentration in Stools
  • Gut Microbiota Diversity and Composition
  • Blood Lipid Profiles
  • Inflammation Biomarkers

Keywords

  • Gut microbiome
  • Gut microbiota
  • Dietary fat
  • Short-chain fatty acids
  • SCFA
  • Saturated fat
  • Monounsaturated fat
  • Polyunsaturated fat
  • Butter
  • Olive oil
  • Coconut oil
  • Sunflower oil
  • MUFA
  • PUFA
03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Butter

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

    Other: Butter

  • Experimental
    Coconut Oil

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

    Other: Coconut oil

  • Experimental
    Extra Virgin Olive Oil

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

    Other: Extra Virgin Olive Oil

  • Experimental
    Sunflower Oil

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

    Other: Sunflower Oil

Interventions

  • OtherButter

    Participants will consume approximately 65 g/day of butter as their primary dietary fat for 14 days, replacing most habitual dietary fat intake.

  • OtherCoconut oil

    Participants will consume approximately 55 g/day of coconut oil as their primary dietary fat for 14 days, replacing most habitual dietary fat intake.

  • OtherExtra Virgin Olive Oil

    Participants will consume 60 mL/day of olive oil as their primary dietary fat for 14 days, replacing most habitual dietary fat intake.

  • OtherSunflower Oil

    Participants will consume 60 mL/day of sunflower oil as their primary dietary fat for 14 days, replacing most habitual dietary fat intake.

05

What researchers measure

Primary outcomes

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

    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.

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

  2. Change in gut microbiota composition

    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.

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

Secondary outcomes

  1. Change in blood lipid profile

    Fasting blood concentrations of total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured using standard enzymatic assays to assess cardiometabolic responses to the dietary fat intervention.

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

  2. Change in inflammatory markers

    Circulating inflammatory markers (e.g., C-reactive protein (CRP), interleukin-6 (IL-6)) will be measured using ELISA or multiplex assays to assess systemic inflammatory responses to the dietary fat intervention.

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

  3. Change in faecal pH

    Faecal pH will be measured to assess changes in the gut environment associated with microbial fermentation.

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

  4. Change in fasting glucose concentrations

    Fasting blood glucose concentrations will be measured to assess changes in glucose metabolism in response to dietary fat intake.

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

  5. Change in faecal fat content

    Faecal fat content will be measured to assess fat excretion and potential differences in fat digestion and absorption across intervention groups.

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

06

Study locations

1 of 1 sites recruiting
  • New Lister Building, Glasgow Royal Infirmary, 10-16 Alexandra Parade, G31 2ER
    Glasgow, G31 2ER, United Kingdom
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07550023
Lead sponsor
University of Glasgow
Collaborators
Dr Dalia Malkova, Professor Konstantinos Gerasimidis
Responsible party
Athanasios Koutsos (Lecturer in Human Nutrition, University of Glasgow) — Principal investigator
First posted
Apr 24, 2026
Start date
Mar 23, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Apr 24, 2026

Study contacts

Linah Alhomidan
Contact
linahalhomidan@gmail.com
+447473477395
Athanasios Koutsos
Contact
Athanasios.Koutsos@glasgow.ac.uk
Athanasios Koutsos
principal investigator · University of Glasgow
Dalia Malkova, PhD
principal investigator · University of Glasgow
Konstantinos Gerasimidis, PhD
principal investigator · University of Glasgow

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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