Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07499414

The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.

Led by University of Reading · Updated on 2026-03-30

40

Participants Needed

1

Research Sites

90 weeks

Total Duration

On this page

Sponsors

U

University of Reading

Lead Sponsor

A

ABC Farmaceutici S.p.A.

Collaborating Sponsor

AI-Summary

What this Trial Is About

In humans and most mammals, bile acids play a role in the metabolism of glucose and the transport and absorption of lipids (such as cholesterol and triglycerides), vitamins, and nutrients by allowing for emulsification (mixing) and absorption of fatty molecules that are consumed. More recently, bile acids have been discovered to influence the composition and quantity of the microorganisms in the gut microbiome. Bile acids also act as signalling molecules (like hormones) in the body, regulating important metabolic pathways and digestion. While the majority of bile acids are recycled back to the liver, a small proportion of these bile acids enter the colon and interact with the gut microbiota. Primary bile acids, synthesized in the liver, are essential for the absorption of fat- and fat-soluble vitamins, as part of the digestive process. These primary bile acids are converted to secondary bile acids by gut bacteria, which have been shown to have benefits to health. This provides the rationale for exploring the use of a bile acid, in this case 7-keto lithocholic acid (7-KLCA), as a beneficial modulator of the gut microbiome, to help regulate metabolic and potentially other disease pathways.

CONDITIONS

Official Title

The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteer is healthy with good physical and mental condition and disease-free
  • Haemoglobin levels between 138 - 172 g/L for males and between 121 - 151 g/L for females
  • Aged 18 to 65 years during the study
  • Able and willing to follow study instructions
  • Suitable for participation according to study staff
  • Able to give informed consent
  • Following a non-restrictive diet (no vegan, keto, or fasting diets)
  • Has not taken probiotic or prebiotic supplements or foods for at least 4 weeks before starting
  • No gastrointestinal disorders
Not Eligible

You will not qualify if you...

  • Cannot understand any local language
  • Has gastrointestinal disorders including IBS or IBD
  • Has food allergies or intolerances
  • Has taken drugs affecting gastrointestinal function in the last 12 weeks
  • Uses laxatives
  • Has clinically significant diabetes (fasting glucose > 6.5 mmol/L)
  • Currently or planning to participate in another clinical or food study
  • History of drug or alcohol abuse
  • Pregnant or breastfeeding
  • Regular intake of probiotic or prebiotic supplements
  • Smoker
  • Follows extreme diets such as keto, Atkins, or vegan
  • Takes prescribed medication for existing health conditions
  • Has a pacemaker

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hugh Sinclair Unit, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR

Reading, United Kingdom

Actively Recruiting

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Research Team

A

Abigail Basson, PhD

CONTACT

K

Kimberly Watson, DPhil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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