Clinical Trial

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

Recruiting
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Record status
This record was last updated July 17, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07071181
Lead Sponsor Sheffield Hallam University
Collaborators: Biotiful, University of Leeds, Nimble Science Ltd.
Conditions Sleep, Cardiovascular Diseases, Gut Microbiome, Cognitive Function and Mood, LDL Cholesterol
Enrollment 40 participants
Start Date 2025-08
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-07-17