- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05080400
White Rice and Effect of Gellan Gum on Glucose Responses by MRI (WIGG)
Effects of Gellan Gum on the Glycemic, Gastrointestinal and Appetitive Responses to a White Rice Meal Assessed by MRI
Rice is a staple food for over half the world's population. High consumption of white rice has been linked with high obesity and increased risk for type 2 diabetes. However, it is still the favoured type of rice among consumers, contributing to the observed increasing trends in diet-related diseases in countries with high rice consumption. Controlling the properties of white rice products (e.g. reducing the glycaemic index and/or increasing satiety) with relatively simple interventions could contribute to producing foods with health-promoting digestibility profiles.
One way to reduce the glycaemic index of white rice is through processing. Addition of food thickeners (called hydrocolloid gums) has previously been shown to reduce the digestibility of foods.
This work will test the hypothesis that gellan gum is a simple way to manipulate the body's glucose response to a white rice which in turn will have health-promoting effects. MRI imaging will be used to monitor the gastrointestinal responses.
Study Overview
Status
Intervention / Treatment
Detailed Description
Addition of hydrocolloids has previously been shown to reduce the digestibility of foods. Hydrocolloids are polysaccharides used to increase viscosity and gelatinization and have many other applications in the food industry. However, there is a lack of mechanistic understanding on how these hydrocolloids may act during digestion in the human body. Preliminary in-house data suggested that the addition of gellan gum to rice cooking may reduce digestibility rates though mechanisms yet to be understood. This work will test the hypothesis that gellan gum can be used to manipulate white rice product properties to enhance health-promoting glycaemic, gastrointestinal and satiety responses in healthy human participants.
Aims:
1. to collect pilot data on postprandial glucose levels of isoenergetic test meal made from rice and Gellan Gum 2 . to collect data on their gastric emptying and satiety. 3. to compare postprandial glucose levels, gastric emptying and satiety for the treatments 4. to explore relationships between glucose levels, gastric emptying and satiety.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nottingham, United Kingdom, NG7 2UH
- Nottingham Digestive Disases Centre , University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2
- Able to give informed consent
- Apparently healthy: no medical conditions or previous gastrointestinal surgery which might affect study measurements (judged by the investigators)
Exclusion Criteria:
- Fasting fingerprick screening blood sugar level higher than 5.4 mmol/L
- Restrained eating behaviour as determined by Eating habits and SCOFF screening questionnaires
- Not used to eating breakfast
- Not used to eating three meals a day
- Use of medication which interferes with study measurements for example acid suppressants or anti-spasmodics.
- Participation in another nutritional or biomedical trial 3 months before the pre-study screening or during the study.
- Reported participation in night shift work during the two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
- Strenuous exercise for more than10 hours per week.
- Consumption of ≥21 alcoholic drinks in a typical week
- Reported weight loss or gain ≥ 10 % of bodyweight during the six months period before the pre-study examination.
- Following a medically- or self-prescribed diet during the two weeks prior to the pre-study examination and until the end of the study
- Dislike of the products served as the dietary test treatments including the pasta meal
- Any allergy or food intolerance to the test treatments
- Not suitable for MRI scanning (e.g., presence of metal implants, infusion pumps and pacemakers) as assessed by standard MRI safety questionnaire.
- Pregnancy or breastfeeding declared by candidate
- Antibiotic or prescribed probiotic treatment in the past 12 weeks
- Inability to lie flat
- Poor understanding of the spoken and/or written English language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gellan gum
White rice cooked with gellan gum
|
Jasmine rice 179g of cooked weight
Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice
|
|
Placebo Comparator: Control
White rice cooked without gellan gum
|
Jasmine rice 179g of cooked weight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental Area Under the Curve of post prandial blood glucose up to 2h (iAUC2h)
Time Frame: 2 hours
|
Fingerprick blood glucose area under the curve for 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ad libitum objective pasta meal at the end of the study day
Time Frame: 3 hours
|
Weighted amount of ad libitum pasta meal consumed at end of study morning
|
3 hours
|
|
Under the Curve for appetite scores post prandial up to 2 hours (AUC2h)
Time Frame: 2 hours
|
Area under the curve of Visual Analogue Scores up to 2 hours postprandially
|
2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Peak of blood glucose
Time Frame: 2 hours
|
Fingerprick blood glucose time to peak
|
2 hours
|
|
Peak blood glucose
Time Frame: 2 hours
|
Fingerprick blood glucose peak value
|
2 hours
|
|
Area Under the Curve of post prandial gastric volumes up to 2h (AUC2h)
Time Frame: 2 hours
|
Gastric volumes area under the curve from MRI images
|
2 hours
|
|
Visual appearance of meal in the stomach
Time Frame: 2 hours
|
Descriptive intragastric appearance (e.g.
layering, boluses) of meal in the stomach
|
2 hours
|
|
Small bowel water content area under the curve (AUC2h)
Time Frame: 2 hours
|
Area under the curve of volume of freely mobile water in the small bowel from MRI images
|
2 hours
|
|
Explorative correlations
Time Frame: 2 hours
|
Explorative correlations between Fingerprick blood glucose area under the curve for 2 hours, Gastric volumes area under the curve from MRI images up to 2 hours postprandially and Area under the curve of appetite Visual Analogue Scores up to 2 hours postprandially
|
2 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 470-2001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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