NCT02655367

Brief Summary

This crossover study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two different porridge meals prepared from either finely milled or flaked oats. On each of two study days, a total of 9 MRI scans will be taken, I baseline and 8 post meal, to assess gastric layering and emptying over three hours. Blood samples will also be taken periodically over the same period in order to determine changes in concentrations of circulating glucose, insulin and key gastrointestinal hormones. Participants will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

January 12, 2016

Last Update Submit

August 31, 2016

Conditions

Metabolic Syndrome

Keywords

MRIoatsporridgesatietyGI hormonesprocessing

Outcome Measures

Primary Outcomes (1)

  • Volume of gastric content

    Three dimensional MRI data will be used to determine the volume of gastric content at each time point and thus allow the calculation of gastric emptying rate

    3 hours

Secondary Outcomes (1)

  • Satiety response

    3 hours

Study Arms (2)

Milled followed by flaked oats

EXPERIMENTAL

Participant consumes test meal consisting of porridge made from milled oats on study day 1, followed by porridge made from flaked oats on study day 2

Other: Flaked oatsOther: Milled oats

Flaked followed by milled oats

EXPERIMENTAL

Participant consumes test meal consisting of porridge made from flaked oats on study day 1, followed by porridge made from milled oats on study day 2

Other: Flaked oatsOther: Milled oats

Interventions

Flaked oatsOTHER

Test meal consisting of 264g porridge made with flaked oats

Flaked followed by milled oatsMilled followed by flaked oats
Milled oatsOTHER

Test meal consisting of 264g porridge made with milled oats

Flaked followed by milled oatsMilled followed by flaked oats

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male (hormonal status of women would introduce more variation within small group)
  • Age 20-55y (people older than the upper age limit for the study, may suffer from degeneration of the GI tract, which would compromise our study data).
  • BMI 19-35 kg/m2
  • Apparently healthy
  • Normally eat lunch and breakfast
  • Willing to eat porridge type meal
  • Willing to be cannulated and have blood samples taken
  • Be able provide written informed consent

You may not qualify if:

  • Potential participants will be excluded if:
  • They are line managed or supervised by any members of the study team either at IFR or NNUHFT Radiology.
  • They are a student with a dependency on any member of the NNUHFT/ IFR study team.
  • They are related to or living with any member of the study team (NNUHFT or IFR).
  • They have an intense dislike of/ intolerance / allergy to any of the constituents of the test meal.
  • They are smokers or have smoked within the last year (smoking affects satiety/hunger); this also includes e-cigarettes.
  • They have been diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease.
  • They have had surgery on the stomach or intestine or suffered from oesophageal or gastrointestinal disease, whether diagnosed or self-reported.
  • They currently suffer from, or have suffered from an eating disorder.
  • They are taking antibiotics on a long-term basis.
  • They regularly (more than once in 10 days) use antacids, laxatives.
  • They have any problems with swallowing.
  • They take prescribed or over the counter medication for digestive or gastrointestinal conditions.
  • They are receiving anticoagulant therapy or have finished anticoagulant therapy within the previous week.
  • They are taking any dietary supplements/ herbal remedies which may affect the study data unless they are willing to stop taking within the appropriate timescale for the study. These will be assessed on an individual basis.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alan R Mackie, PhD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-01

Locations

GB(1)