NCT01925053

Brief Summary

This exploratory study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of a Palaeolithic inspired meal and a reference meal. Two types of meals, one high in fruit and vegetables will be used, and one based on WHO nutritional guidelines. Previous data suggests that the former meal releases nutrients more slowly than the latter. On each of two study days, a total of 11 MRI scans will be taken, 1 baseline and 10 post meal, to assess gastric layering and emptying. 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
4

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable obesity

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

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

August 15, 2013

Last Update Submit

February 26, 2014

Conditions

Obesity

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

    Every 20 mins for 3 hours

Secondary Outcomes (1)

  • Satiety response

    Every 20 minutes for 3 hours

Study Arms (2)

Ref meal

PLACEBO COMPARATOR

The reference meal (REF) is based on WHO dietary guidelines for protein, fat and carbohydrate. It comprises everyday "modern" ingredients such as white rice.

Other: REF meal

PAL meal

ACTIVE COMPARATOR

Palaeolithic meal (PAL) is based on WHO dietary guidelines for protein, fat and carbohydrate but only uses ingredients that would have been available in Palaeolithic times (e.g. no cereals or dairy).

Other: PAL meal

Interventions

PAL mealOTHER

The effect of consuming the PAL meal on gastric retention will be assessed

PAL meal
REF mealOTHER

The effect of consuming the REF meal on gastric retention will be assessed

Ref meal

Eligibility Criteria

Age20 Years - 50 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 20-50y BMI 19-35 kg/m2 Apparently healthy Normally eat lunch and breakfast Provide written informed consent

You may not qualify if:

  • The subject is line managed the any members of the study team either at IFR or NNUH Radiology or a student with a dependency on any member of the NNUH study team, or is related to or living with any member of the study team.
  • Individuals with an intense dislike of or intolerance / allergy to any of the constituents of the test meal
  • Smokers or smoked within the last year (smoking affects satiety/hunger)
  • Diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease
  • Have had surgery on the stomach or intestine or suffered from oesophageal or gastrointestinal disease, whether diagnosed or self-reported
  • Regular (more than once in 10 days) use of antacids, laxatives
  • Any problems with swallowing
  • Take medication for digestive or gastrointestinal conditions.
  • Participants taking part in another study (other than a questionnaire based study).
  • Blood pressure greater than 160/100 mmHg or less than 90/50 or 95/55 mmHg if symptomatic.
  • Individuals with special dietary requirements (eg vegetarians)
  • If any of the clinical screening results are indicative of a health problem which would affect the participants well-being or which would affect the study data.
  • Refusal to give permission to inform GP of participation in study
  • Recent unexplained weight gain or loss
  • History of back problems or any other condition which limit ability to repeatedly sit up and lie down
  • +11 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

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

August 15, 2013

First Posted

August 19, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

GB(1)