Diet, HealthyNCT06758570
Effect Dietary Fibre Supplementation on Gut Microbiota Composition
A study testing Pectin dosages in people with Diet, Healthy and Systemic Inflammatory Response, run by Elizabeth Simpson at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Systemic Inflammatory Response
- What is being tested?
- Pectin dosages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Modulatory Effects of Dietary Fibres on the Composition and Function of the Gut Microbiome- A Dose-response Study
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.
Read the 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.
- Conditions
- Diet, Healthy, Systemic Inflammatory Response
- Being tested
- Pectin dosages
- Keywords
- Dietary intervention, Gut microbiome, Dose- response, Systemic inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectin dosagesDietary supplement
15 individuals were provided with increasing doses of pectin: 5g for 2 weeks 10g for 2 weeks 15 for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose response effect of Pectin | Experimental | In order to investigate the dose-response effect of dietary pectin fibre, pectin was provided to healthy volunteers in increasing doses of 5g, 10g and 15g for a period of 2 weeks each with samples and data collected prior to each dosing period. Receives: Dietary Supplement: Pectin dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome profile
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks)
Measured: 6 weeks
Change in inflammatory profile
Change in circulating markers of inflammation measured by ELISAs in serum samples collected at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).
Measured: 6 weeks
Changes in short chain fatty acids (SCFAs)
Change in serum SCFAs measured by mass spectrometry at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).
Measured: 6 weeks
Secondary outcomes (8)
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.
Measured: 6 weeks
Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score
Change in 'SF36' 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 at the start and the end of each dosing period
Measured: 6 weeks
Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score
Change in 'SF36' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing; measured at the start and the end of each dosing period
Measured: 6 weeks
Dose response change in Pittsburgh Sleep Quality Index (PSQI)
Change in PSQI score (min score 0, max 21), measured at the start and the end of each dosing period, with higher score indicating poorer sleep quality
Measured: 6 weeks
Dose response change in Hospital Anxiety and Depression scores (HADS)
Change in anxiety score (min 0, max 3 which higher scores indicating higher anxiety like symptoms) and depression scores (min 3, max 0 which lower scores indicating higher depressive like symptoms), measured at the start and at the end of each dosing period
Measured: 6 weeks
Change in systolic blood pressure (lying to standing) post every dosing period
Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at the end of each dosing period (every 2 weeks)
Measured: 6 weeks
Change in diastolic blood pressure (lying to standing) post every dosing period
Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at the end of each dosing period (every 2 weeks)
Measured: 6 weeks
Change in diastolic blood pressure (lying to standing) at pre intervention study visit
Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), pre intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start5 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose-response study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Simpson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Ana Valdes, Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758570
- Sponsor's protocol ID
- FMHS 302-0621(Dose response)
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulatory Effects of Dietary Fibres on the Composition and Function of the Gut Microbiome- A Dose-response Study
- ClinicalTrials.gov ID
- NCT06758570
- Acronym / sponsor ID
- FMHS 302-0621(Dose response)
- Conditions
- Diet, Healthy, Systemic Inflammatory Response
- Keywords
- Dietary intervention, Gut microbiome, Dose- response, Systemic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Elizabeth SimpsonUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose-response study
| Arm | Type | Receives |
|---|---|---|
| Dose response effect of Pectin | Experimental | Dietary Supplement: Pectin dosagesIn order to investigate the dose-response effect of dietary pectin fibre, pectin was provided to healthy volunteers in increasing doses of 5g, 10g and 15g for a period of 2 weeks each with samples and data collected prior to each dosing period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pectin dosages15 individuals were provided with increasing doses of pectin: 5g for 2 weeks 10g for 2 weeks 15 for 2 weeks | Dietary supplement | Dose response effect of Pectin |
Primary outcome
Change in microbiome profile
Time frame: 6 weeks
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks)
Change in inflammatory profile
Time frame: 6 weeks
Change in circulating markers of inflammation measured by ELISAs in serum samples collected at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).
Changes in short chain fatty acids (SCFAs)
Time frame: 6 weeks
Change in serum SCFAs measured by mass spectrometry at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).
8 secondary outcomes
Change in systolic blood pressure (lying to standing) pre intervention
Time frame: 6 weeks
Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score
Time frame: 6 weeks
Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score
Time frame: 6 weeks
Dose response change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks
Dose response change in Hospital Anxiety and Depression scores (HADS)
Time frame: 6 weeks
Change in systolic blood pressure (lying to standing) post every dosing period
Time frame: 6 weeks
Change in diastolic blood pressure (lying to standing) post every dosing period
Time frame: 6 weeks
Change in diastolic blood pressure (lying to standing) at pre intervention study visit
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Valdes, Professor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectin dosages in people with Diet, Healthy and Systemic Inflammatory Response, run by Elizabeth Simpson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome profile (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.