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

RecruitingNAAges 40 Years - 70 YearsAllSheffield Hallam University
NCT07071181 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, partici

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📋 Eligibility rules (as published)
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
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What it tests

  • Original flavour kefir
  • Milk
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Where

2 sites
University of Leeds
Leeds, United Kingdom
College of Health, Wellbeing and Life Sciences
Sheffield, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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