The Effects of Dietary Fibres on Metabolic Health and the Gut Microbiome
NCT Number: NCT06580132
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diet|Healthy|Systemic Inflammatory Response
Interventions: DIETARY_SUPPLEMENT: Pectin|DIETARY_SUPPLEMENT: Maltodextrin
Sponsor: Elizabeth Simpson
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-09-09
Completion Date: 2022-09-09
Locations: University of Nottingham, Nottingham, NG7 2UH, United Kingdom

Summary:
The study involves intake of dietary supplements, which are commonly found in the UK diet (not pharmacological agents) to test their effects on inflammation in the body and gut microbiome composition. Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either the dietary fibres (the current trial focussed on pectin) or placebo (maltodextrin). At each study visit (\~3hrs), participants will be asked to provide a stool and blood sample and will have blood pressure measured. In the week before each study visit, participants will record their food intake.

Primary Outcome Measures: Change in microbiome profile, Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period, 4 weeks|Change in inflammatory profile, Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period., 4 weeks|Changes in short chain fatty acids (SCFAs), Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period, 4 weeks
Secondary Outcome Measures: Change in systolic blood pressure (lying to standing) pre intervention, Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit, 4 minutes|Change in systolic blood pressure (lying to standing) post intervention, Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit, 4 minutes|Change in diastolic blood pressure (lying to standing) pre intervention, Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit, 4 minutes|Change in diastolic blood pressure (lying to standing) post intervention, Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit, 4 minutes|Change in Short Form Health Survey (SF12) Questionnaire aggregated normalised 'physical' score, Change in 'SF12' Questionnaire aggregated 'physical' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing; measured pre and post intervention, 4 weeks|Change in Short Form Health Survey (SF12) Questionnaire aggregated normalised 'mental' score, Change in 'SF12' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better mental wellbeing; measured pre and post intervention, 4 weeks|Change in Pittsburgh Sleep Quality Index (PSQI), Change in PSQI score (min score 0, max 21), measured pre and post the 4-week intervention, with higher score indicating poorer sleep quality, 4 weeks|Change in Hospital Anxiety and Depression Score (HADS), Change in anxiety score (min score 0, max 3 with higher score indicating higher anxiety like symptoms), and depression score (min 3, max 0 with lower the scores indicating higher depression like symptoms) measured pre and post the 4-week intervention., 4 weeks