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

NCT07071181 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-17

No results posted yet for this study

Summary

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

Interventions

DIETARY_SUPPLEMENT

Original flavour kefir

Participants will consume 250ml of original flavour kefir daily for 4 weeks. According to the manufacturer, "packed with billions of live cultures to support Gut health".

OTHER

Milk

Participants will consume 250 ml milk daily for 4 weeks. This milk will not contain any live cultures.

Sponsors & Collaborators

  • Biotiful

    collaborator UNKNOWN
  • University of Leeds

    collaborator OTHER
  • Nimble Science Ltd.

    collaborator INDUSTRY
  • Sheffield Hallam University

    lead OTHER

Principal Investigators

  • Tony Lynn, PhD · Sheffield Hallam University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071181 on ClinicalTrials.gov