DietNCT06580132
The Effects of Dietary Fibres on Metabolic Health and the Gut Microbiome
A study testing Pectin and Maltodextrin in people with Diet and Healthy, run by Elizabeth Simpson at 1 site in United Kingdom.
Trial 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. 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 and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2021to 9 Sep 2022
- 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
- The participant may not enter the study if ANY of the following apply:
- Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
- Are taking the following medications: immunosuppressants, 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 breastfeeding
- 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 Pilot Randomised Placebo-controlled Dietary Intervention Study
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.
Read the detailed description
The overall aim of the proposed project is to unlock the effect of dietary fibres (i.e. LM Pectin) on anti-inflammatory and cardioprotective metabolic responses via the modulation of the gut microbiome and SCFAs production.
Specific Aim 1: To deliver a wealth of molecular data, including effect sizes, on the physiological effects of dietary fibres on the changes in the composition and function of the gut microbiome and changes in the metabolomic and physiological profile of an individual.
Specific Aim 2: To investigate the mechanisms whereby the gut microbiome modulates crucial physiological parameters such, blood glucose regulation, hunger and appetite, immune function markers in response to the anti-inflammatory effects of the gut microbiome.
30 healthy, non-obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and in the final week of the 4-week intervention (before the second 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 randomised to receive either the dietary fibre or placebo powder. They will be given the blinded products 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 visit 2 will be scheduled at the end of the 4 week 'dosing' period.
- Conditions
- Diet, Healthy, Systemic Inflammatory Response
- Being tested
- Pectin, Maltodextrin
- Keywords
- Dietary intervention, Gut microbiome, Systemic inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PectinDietary supplement
Pectin fibre (20g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.
MaltodextrinDietary supplement
Maltodextrin (10g) served as a control/ placebo to compare the effects observed with pectin.
| Study group | Role | What they receive |
|---|---|---|
| Fibre arm (Pectin) | Active comparator | 20g of pectin was provided to healthy volunteers for 4 weeks. Receives: Dietary Supplement: Pectin |
| Maltodextrin | Placebo comparator | 10g of maltodextrin was provided to healthy volunteers for 4 weeks Receives: Dietary Supplement: Maltodextrin |
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 pre and post the 4-week intervention period
Measured: 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.
Measured: 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
Measured: 4 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: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start9 Sep 2021
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DietStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 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
- NCT06580132
- Sponsor's protocol ID
- FMHS 302-0621
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- 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 30 Aug 2024. 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 Pilot Randomised Placebo-controlled Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT06580132
- Acronym / sponsor ID
- FMHS 302-0621
- Conditions
- Diet, Healthy, Systemic Inflammatory Response
- Keywords
- Dietary intervention, Gut microbiome, Systemic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Elizabeth SimpsonUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 30 Aug 2024 (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 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.
Detailed description
The overall aim of the proposed project is to unlock the effect of dietary fibres (i.e. LM Pectin) on anti-inflammatory and cardioprotective metabolic responses via the modulation of the gut microbiome and SCFAs production.
Specific Aim 1: To deliver a wealth of molecular data, including effect sizes, on the physiological effects of dietary fibres on the changes in the composition and function of the gut microbiome and changes in the metabolomic and physiological profile of an individual.
Specific Aim 2: To investigate the mechanisms whereby the gut microbiome modulates crucial physiological parameters such, blood glucose regulation, hunger and appetite, immune function markers in response to the anti-inflammatory effects of the gut microbiome.
30 healthy, non-obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and in the final week of the 4-week intervention (before the second 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 randomised to receive either the dietary fibre or placebo powder. They will be given the blinded products 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 visit 2 will be scheduled at the end of the 4 week 'dosing' period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Controlled intervention
| Arm | Type | Receives |
|---|---|---|
| Fibre arm (Pectin) | Active comparator | Dietary Supplement: Pectin20g of pectin was provided to healthy volunteers for 4 weeks. |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin10g of maltodextrin was provided to healthy volunteers for 4 weeks |
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 (8 listed)
- Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
- Are taking the following medications: immunosuppressants, 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 breastfeeding
- 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 |
|---|---|---|
| PectinPectin fibre (20g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers. | Dietary supplement | Fibre arm (Pectin) |
| MaltodextrinMaltodextrin (10g) served as a control/ placebo to compare the effects observed with pectin. | Dietary supplement | Maltodextrin |
Primary outcome
Change in microbiome profile
Time frame: 4 weeks
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period
Change in inflammatory profile
Time frame: 4 weeks
Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period.
Changes in short chain fatty acids (SCFAs)
Time frame: 4 weeks
Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period
8 secondary outcomes
Change in systolic blood pressure (lying to standing) pre intervention
Time frame: 4 minutes
Change in systolic blood pressure (lying to standing) post intervention
Time frame: 4 minutes
Change in diastolic blood pressure (lying to standing) pre intervention
Time frame: 4 minutes
Change in diastolic blood pressure (lying to standing) post intervention
Time frame: 4 minutes
Change in Short Form Health Survey (SF12) Questionnaire aggregated normalised 'physical' score
Time frame: 4 weeks
Change in Short Form Health Survey (SF12) Questionnaire aggregated normalised 'mental' score
Time frame: 4 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
Change in Hospital Anxiety and Depression Score (HADS)
Time frame: 4 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 30 Aug 2024.
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Healthy Volunteers
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 and Maltodextrin in people with Diet and Healthy, 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 8 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 30 Aug 2024. 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. Some participants in this study may receive a placebo. 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: 4 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 30 Aug 2024.