Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered 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
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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