Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
Healthy Volunteers
NCT07071181

Effects of Milk-based Drinks on Gut Microbiome, Sleep and Cardiometabolic Markers

Led by Sheffield Hallam University · Updated on 2025-07-17

40

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

Sponsors

S

Sheffield Hallam University

Lead Sponsor

B

Biotiful

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the effects of kefir on gastrointestinal health, sleep quality, and biochemical parameters in adults who have sleep problems. Further measurements of cognitive function, arterial stiffness and blood pressure will also be assessed. The following questions will be addressed during the study: 1. What effect does repeated ingestion of kefir have on the gut microbiome and can this positively influence sleep performance (quality and duration) in adults with sleep problems? 2. Does repeated ingestion of kefir impact LDL, triacyglycerols and non-HDLc in adults with sleep problems? 3. What effect does repeated ingestion of kefir have on cognitive function and mood? 4. What effect does repeated ingestion of kefir have on vascular function, inflammation and markers of immunity in adults with sleep problems? In a randomised, crossover design study, participants will consume 250 ml of kefir (original flavour) or milk for 4 weeks with a 4-week washout.

CONDITIONS

Official Title

Effects of Milk-based Drinks on Gut Microbiome, Sleep and Cardiometabolic Markers

Who Can Participate

Age: 40Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 40 to 70 years old
  • Experience poor sleep with a Pittsburgh Sleep Quality Index score greater than 5
  • Body mass index (BMI) between 25 and 35 kg/m2
  • Willing to consume each study drink daily for 4 weeks and attend four laboratory visits
  • For women, stable use of contraception or hormone replacement therapy for at least 3 months prior to the study start
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to milk-based products
  • Currently pregnant or breastfeeding
  • Insufficient English skills to complete questionnaires and cognitive tests
  • Diagnosed gastrointestinal disorders
  • Unable to attend laboratory visits due to travel or mobility issues

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Leeds

Leeds, West Yorkshire, United Kingdom, LS29JT

Not Yet Recruiting

2

College of Health, Wellbeing and Life Sciences

Sheffield, United Kingdom, S1 1WB

Actively Recruiting

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Research Team

T

Tony Lynn,, PhD

CONTACT

L

Lucy Ellis, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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