NCT06758570

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

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

October 5, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

August 28, 2024

Last Update Submit

January 2, 2025

Conditions

Diet, HealthySystemic Inflammatory Response

Keywords

Dietary interventionGut microbiomeDose- responseSystemic inflammation

Outcome Measures

Primary Outcomes (3)

  • 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)

    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).

    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).

    6 weeks

Secondary Outcomes (8)

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

    6 weeks

  • Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score

    6 weeks

  • Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score

    6 weeks

  • Dose response change in Pittsburgh Sleep Quality Index (PSQI)

    6 weeks

  • Dose response change in Hospital Anxiety and Depression scores (HADS)

    6 weeks

  • +3 more secondary outcomes

Study Arms (1)

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.

Dietary Supplement: Pectin dosages

Interventions

Pectin dosagesDIETARY_SUPPLEMENT

15 individuals were provided with increasing doses of pectin: 5g for 2 weeks 10g for 2 weeks 15 for 2 weeks

Dose response effect of Pectin

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Study Officials

  • Ana Valdes, Professor

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Dose-response study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

August 28, 2024

First Posted

January 6, 2025

Study Start

October 5, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 6, 2025

Record last verified: 2025-01

Locations

GB(1)