Chocolate Meal Study

NCT01383902 | Completed DMC

• 1 other identifier: IFR03/2008
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of challenge meals. Two types of meal will be compared, chocolate mousse style dessert and chocolate bars. The information from this study will then be compared to the elicitation times for both objective and subjective symptoms in the allergic patients who have been challenged in a different study using the same two meals.

Conditions

Impact of Food Composition on Gastric Emptying

Outcome Measures

Primary Outcomes (1)

• A series of MRI images of the abdomen giving gastric emptying and layering data

  To produce gastric emptying and layering data from MRI images on healthy volunteers using a nine differing dose protocol in two different foods.

  4 hours

Secondary Outcomes (1)

• Use of MRI for measuring gastric emptying rates

  4 hours

Study Arms (1)

dessert / chocolate

OTHER

Other: Food type

Interventions

Food type OTHER

1ml, 1ml, 5ml, 50ml, 6ml, 20ml, 60ml and 200ml of chocolate dessert or 1 g, 1 segment (5 segments to a bar) repeated 6 times, 2 bars repeated twice of chocolate bars

dessert / chocolate

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male (hormonal status of women would introduce more variation within small group)
• Age 20-50y
• BMI 19-30
• Nominally healthy
• Normally eat lunch
• Willing to eat dark chocolate bars and chocolate dessert.
• Provides informed written consent

You may not qualify if:

• Smokers or smoked within the last year (smoking affects satiety/hunger and volunteer's will not be able to smoke during the study day at the hospital)
• 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 gastrointestinal disease.
• Regular (more than once in 10 days) use of antacids, laxatives
• Diagnosis with any mouth, dental, throat or digestive problem that may affect normal eating and digestion of food.
• Volunteers taking part in another study (other than a questionnaire based study).
• Blood pressure greater than 160/100 or less than 90/50 or 95/55 if symptomatic.
• Individuals with special dietary requirements (eg vegetarians)
• People with eating disorders (eg. anorexia, bulimia)
• If any of the clinical screening results are indicative of a health problem which would affect the volunteers well-being or which would affect the study data.
• Refusal to give permission to inform GP of participation in study
• Allergic to any of the constituents of the test meal
• Recent unexplained weight gain or loss
• History of back problems or any other condition which limit ability to repeatedly sit up and lie down
• Hiatus Hernia

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

GB (2)