NCT07071181 Effects of Milk-based Drinks on Gut Microbiome, Sleep and Cardiometabolic Markers
| NCT ID | NCT07071181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Hallam University |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Aged 40-70 years old * Suffer with poor sleep (measured using the PIttsburg Sleep Quality Index with a score \> 5) * BMI in range of 25-35 kg/m2 * Willingness to consume each study drink daily for 4 weeks and attend the laboratory on 4 separate occasions * For women: Medication in the form of contraception or HRT providing these have not been modified 3 months prior to the first study day Exclusion Criteria: * Intolerance or allergy to milk-based products * Pregnancy/breastfeeding * Insufficient English language skills to complete all study questionnaires and perform the cognitive tests * Gastrointestinal disorders * Inability to attend the laboratory due to travel/mobility difficulties
Contact & Investigator
Tony Lynn, PhD
PRINCIPAL INVESTIGATOR
Sheffield Hallam University
Frequently Asked Questions
Who can join the NCT07071181 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07071181 currently recruiting?
Yes, NCT07071181 is actively recruiting participants. Contact the research team at T.lynn@shu.ac.uk for enrollment information.
Where is the NCT07071181 trial being conducted?
This trial is being conducted at Leeds, United Kingdom, Sheffield, United Kingdom.
Who is sponsoring the NCT07071181 clinical trial?
NCT07071181 is sponsored by Sheffield Hallam University. The principal investigator is Tony Lynn, PhD at Sheffield Hallam University. The trial plans to enroll 40 participants.