NCT03581812

Brief Summary

The purpose of this study is to evaluate the impact of replacing usual snacks with alternative snack foods on gut health in a population of habitual snackers with low fibre intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

April 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

June 23, 2018

Last Update Submit

February 3, 2020

Conditions

Human MicrobiomeEating Behavior

Keywords

Gut MicrobiotaMicrobiomeGut HealthSnack

Outcome Measures

Primary Outcomes (2)

  • Faecal bifidobacteria

    Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples

    Baseline

  • Faecal bifidobacteria

    Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples

    Day 28

Secondary Outcomes (29)

  • Whole gut transit time

    Baseline

  • Whole gut transit time

    Day 28

  • Regional gut transit time

    Baseline

  • Regional gut transit time

    Day 28

  • Regional gut pH

    Baseline

  • +24 more secondary outcomes

Other Outcomes (2)

  • Adverse events

    From baseline - day 28

  • Acceptability of snack products

    Day 28

Study Arms (3)

Intervention snack 1

ACTIVE COMPARATOR

Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.

Dietary Supplement: Intervention snack 1

Intervention snack 2

ACTIVE COMPARATOR

Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.

Dietary Supplement: Intervention snack 2

Control snack

PLACEBO COMPARATOR

Control snack food reflecting the macro-nutrient profile of a typical UK snack.

Dietary Supplement: Control snack

Interventions

Intervention snack 1DIETARY_SUPPLEMENT

To be eaten instead of regular snacks twice a day for 4 weeks.

Intervention snack 1
Intervention snack 2DIETARY_SUPPLEMENT

To be eaten instead of regular snacks twice a day for 4 weeks.

Intervention snack 2
Control snackDIETARY_SUPPLEMENT

To be eaten instead of regular snacks twice a day for 4 weeks.

Control snack

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Aged between 18-45 years
  • Body mass index (BMI) of 18.5 - 29.9 kg/m2
  • Regular consumption of snacks (≥2 per day, excluding fruit and nut snacks)
  • Low fibre intake (\<22 g/d)
  • Willing to follow the protocol and provide consent

You may not qualify if:

  • Allergy or intolerance to snack ingredients (assessed at screening)
  • Dislike of study snacks
  • Regular consumption of intervention foods as snacks (twice a day in last month)
  • Diabetes
  • Major active psychiatric conditions (e.g. schizophrenia) or current eating disorder
  • Active treatment for cancer in the last year
  • Severe renal, cardiac or pulmonary disease or any other chronic medical condition
  • Severe oesophagitis, gastritis or duodenitis
  • Active diverticulitis or intestinal/colonic strictures
  • Crohns disease or Ulcerative colitis
  • Abdominal surgery (except appendicectomy or cholecystectomy)
  • Irritable bowel syndrome
  • Functional constipation
  • Functional diarrhoea
  • Antibiotics (past 4 weeks)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London Waterloo Campus

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • Creedon AC, Dimidi E, Hung ES, Rossi M, Probert C, Grassby T, Miguens-Blanco J, Marchesi JR, Scott SM, Berry SE, Whelan K. The impact of almonds and almond processing on gastrointestinal physiology, luminal microbiology, and gastrointestinal symptoms: a randomized controlled trial and mastication study. Am J Clin Nutr. 2022 Dec 19;116(6):1790-1804. doi: 10.1093/ajcn/nqac265.

    PMID: 36130222DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Kevin Whelan, Prof.

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dietetics

Study Record Dates

First Submitted

June 23, 2018

First Posted

July 10, 2018

Study Start

April 27, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)