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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorSheffield Hallam University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Original flavour kefir
  • Milk

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sheffield Hallam University

Lead sponsor

Biotiful

Collaborator

University of Leeds

Collaborator

Nimble Science Ltd.

Collaborator