NCT06580132

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 28, 2024

Last Update Submit

August 28, 2024

Conditions

DietHealthySystemic Inflammatory Response

Keywords

Dietary interventionGut microbiomeSystemic inflammation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Change in systolic blood pressure (lying to standing) pre intervention

    4 minutes

  • Change in systolic blood pressure (lying to standing) post intervention

    4 minutes

  • Change in diastolic blood pressure (lying to standing) pre intervention

    4 minutes

  • Change in diastolic blood pressure (lying to standing) post intervention

    4 minutes

  • Change in Short Form Health Survey (SF12) Questionnaire aggregated normalised 'physical' score

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Fibre arm (Pectin)

ACTIVE COMPARATOR

20g of pectin was provided to healthy volunteers for 4 weeks.

Dietary Supplement: Pectin

Maltodextrin

PLACEBO COMPARATOR

10g of maltodextrin was provided to healthy volunteers for 4 weeks

Dietary Supplement: Maltodextrin

Interventions

PectinDIETARY_SUPPLEMENT

Pectin fibre (20g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.

Fibre arm (Pectin)
MaltodextrinDIETARY_SUPPLEMENT

Maltodextrin (10g) served as a control/ placebo to compare the effects observed with pectin.

Maltodextrin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

Pectinsmaltodextrin

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Ana Valdes, Professor

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded study
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Controlled intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

September 9, 2021

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations

GB(1)