WIGG: White Rice and Effect of Gellan Gum on Glucose Responses by MRI

Sponsor
University of Nottingham (Other)
Overall Status
Completed
CT.gov ID
NCT05080400
Collaborator
University of Copenhagen (Other)
12
1
2
4.3
2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: White rice
  • Dietary Supplement: Gellan gum
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomised 2-way crossover studyrandomised 2-way crossover study
Masking:
Single (Participant)
Masking Description:
Participant blind to cooking process
Primary Purpose:
Basic Science
Official Title:
Effects of Gellan Gum on the Glycemic, Gastrointestinal and Appetitive Responses to a White Rice Meal Assessed by MRI
Actual Study Start Date :
Jul 14, 2021
Actual Primary Completion Date :
Oct 27, 2021
Actual Study Completion Date :
Nov 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gellan gum

White rice cooked with gellan gum

Dietary Supplement: White rice
Jasmine rice 179g of cooked weight

Dietary Supplement: Gellan gum
Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice

Placebo Comparator: Control

White rice cooked without gellan gum

Dietary Supplement: White rice
Jasmine rice 179g of cooked weight

Outcome Measures

Primary Outcome Measures

  1. Incremental Area Under the Curve of post prandial blood glucose up to 2h (iAUC2h) [2 hours]

    Fingerprick blood glucose area under the curve for 2 hours

Secondary Outcome Measures

  1. Ad libitum objective pasta meal at the end of the study day [3 hours]

    Weighted amount of ad libitum pasta meal consumed at end of study morning

  2. Under the Curve for appetite scores post prandial up to 2 hours (AUC2h) [2 hours]

    Area under the curve of Visual Analogue Scores up to 2 hours postprandially

Other Outcome Measures

  1. Time to Peak of blood glucose [2 hours]

    Fingerprick blood glucose time to peak

  2. Peak blood glucose [2 hours]

    Fingerprick blood glucose peak value

  3. Area Under the Curve of post prandial gastric volumes up to 2h (AUC2h) [2 hours]

    Gastric volumes area under the curve from MRI images

  4. Visual appearance of meal in the stomach [2 hours]

    Descriptive intragastric appearance (e.g. layering, boluses) of meal in the stomach

  5. Small bowel water content area under the curve (AUC2h) [2 hours]

    Area under the curve of volume of freely mobile water in the small bowel from MRI images

  6. Explorative correlations [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nottingham Digestive Disases Centre , University of Nottingham Nottingham United Kingdom NG7 2UH

Sponsors and Collaborators

  • University of Nottingham
  • University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luca Marciani, Professor of Gastrointestinal Imaging, University of Nottingham
ClinicalTrials.gov Identifier:
NCT05080400
Other Study ID Numbers:
  • 470-2001
First Posted:
Oct 15, 2021
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luca Marciani, Professor of Gastrointestinal Imaging, University of Nottingham

Study Results

No Results Posted as of Nov 29, 2021