Clinical trial NCT06758570: Effect Dietary Fibre Supplementation on Gut Microbiota Composition
Official title: The Modulatory Effects of Dietary Fibres on the Composition and Function of the Gut Microbiome- A Dose-response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Systemic Inflammatory Response
Keywords: Dietary intervention
Gut microbiome
Dose- response
Systemic inflammation
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dose-response study
Primary purpose: BASIC_SCIENCE

Brief summary: The study involves taking pectin fibre at increasing doses ranging from 5g, 10g and 15g for a total period of 6 weeks with the increase every 2 weeks. Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 4 occasions; at the start of the intervention and every 2 weeks, at the end of each dosing period. 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.

Detailed description: The study aims to assess the optimal dosage of pectin required to see beneficial effects on inflammation and gut microbiome composition. 15 healthy, non-obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and at the end of each dosing period (before each study visit), participants will be asked to complete a dietary record (4 days), to collect a stool sample on the day before the study visit and to fast from midnight the night before this visit.

At both study visits, participants will have weight, hip/waist circumference and blood pressure measured. They will be asked to complete some questionnaires. After completion of the first study day, participants will be provided with the required dosage of pectin for the 2-week dosing period. They will be given the required doses of pectin portioned in individual sachets, with instructions to add the contents of one sachet a day to juice, smoothies or water and to consume immediately. Study visits will be scheduled at the end of every 2-weeks.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2

Exclusion Criteria:

* Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
* Are taking the following medications: immunosuppressants, anti-histamines, amiodarone and/or perhexiline
* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program/ taking prebiotic supplements
* Pregnant or breast feeding
* History or current psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Primary outcomes:
measure: Change in microbiome profile
timeFrame: 6 weeks
measure: Change in inflammatory profile
timeFrame: 6 weeks
measure: Changes in short chain fatty acids (SCFAs)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in systolic blood pressure (lying to standing) pre intervention
timeFrame: 6 weeks
measure: Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score
timeFrame: 6 weeks
measure: Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score
timeFrame: 6 weeks
measure: Dose response change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 weeks
measure: Dose response change in Hospital Anxiety and Depression scores (HADS)
timeFrame: 6 weeks
measure: Change in systolic blood pressure (lying to standing) post every dosing period
timeFrame: 6 weeks
measure: Change in diastolic blood pressure (lying to standing) post every dosing period
timeFrame: 6 weeks
measure: Change in diastolic blood pressure (lying to standing) at pre intervention study visit
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Ana Valdes, Professor
role: PRINCIPAL_INVESTIGATOR
References: