White Rice and Gellan Gum 7 Days Intervention (WIGG2)

November 27, 2023 updated by: Moira Taylor

The Effects of Gellan Gum on the Acute Glycaemic and Appetitive Responses to a White Rice Meal and Impact on Energy Intake Over 7 Days

Gellan gum (GG) is a food grade polysaccharide produced by fermentation. In-vitro studies and in vivo pilot studies suggest that adding gellan gum to rice during cooking might reduce the extent of the increase in circulating blood glucose seen after its consumption (glycaemic response). This study will explore whether such a modification in response is sustained, particularly over a period of 7 days of consumption.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND: Rice is a carbohydrate-rich staple source of food for around half of the world population. Consumption is estimated to be 480 million tonnes per year. According to The Food and Agriculture Organization of the United Nations (FAO), rice is easily accessible to people in Asia, Pacific region, parts of Latin America and the Caribbean and, increasingly in Africa. Rice plays an important role in achieving an adequate dietary intake in these countries.

However high consumption of white rice has been linked with high obesity rates 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 . Modifying the properties of white rice products (e.g. reducing the glycaemic index and/or increasing satiety) with relatively simple interventions can contribute to producing foods that may promote better health due to modified digestion and post prandial metabolic and appetitive profiles. One way to reduce the glycaemic index of white rice may be the addition of hydrocolloids. These have previously been shown to modify the digestibility of foods . The health advantage derived from such modifications would be beneficial for consumers worldwide. Preliminary in-house in vitro digestion data suggested that the addition of gellan gum to rice cooking may reduce digestibility rates though mechanisms yet to be understood. Gellan gum (GG) "is a high molecular weight, water-soluble anionic, extracellular polysaccharide which is produced by the microorganism Sphingomonas elodea during fermentation". GG is commonly used as a gelling agent in foods. Gels formed by gellan gum have high resistance to acid, heat, and enzyme activity. The United States Food and Drug Administration (FDA) has approved the use of GG as a food additive for the human consumption (US.FDA, 2018). It is also approved by the European Community as a food additive with code (E-418). Gellan Gum is gluten free and broadly applied in gluten free foods to provide improved texture and good taste to pasta, biscuits, candy and dairy products. Therefore, it has been proved safe in the amounts the investigators intend to use, it is also suitable for people diagnosed with Coeliac disease as well as suitable for vegetarians, kosher and Halal diets, which make it acceptable for consumption and dietary intervention across different populations.

AIM: The overall purpose of this study is to explore the impact of cooking rice with gellan on the glycaemic and appetitive responses in healthy participants. Both the acute response to one meal will be considered, and the impact on the acute response having consumed the rice once a day over the preceding 7 days. Tolerance will also be considered.

HYPOTHESIS: This work will test the hypothesis that the addition of gellan gum to jasmine rice during cooking will reduce the post prandial glycaemic response. The investigators will also explore associated food intake, appetitive responses and tolerance during both the acute single meal exposure and over a 7 day period of consuming the same portion of rice each day, therefore testing the stability of the glycaemic and appetitive responses after a 7 day period of consumption. Establishing that any acute effect noted is sustained over a period of consumption will be important prior to recommending the addition of gellan to rice cooking as a therapeutic or public health strategy.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Not currently taking any medications (except the oral contraceptive pill)
  • Aged 18-65 years old
  • 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.

Exclusion Criteria:

  • Fasting finger prick screening blood sugar level higher than 5.4 mmol/L
  • Restrained eating behaviour as determined by Eating habits and SCOFF screening questionnaires
  • 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 than 10 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
  • Any allergy or food intolerance to the test treatments
  • Pregnancy or breastfeeding declared by candidate
  • Antibiotic or prescribed probiotic treatment in the past 12 weeks
  • Poor understanding of the spoken and/or written English language
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gellan gum
White rice test meal boiled in 356 g water containing 5.5g of gellan to each 185g of uncooked rice (50 g of available carbohydrate). Consumed on Day 1 at the study site, then consumed at home once daily for 7 days, then consumed again once at test site at Day 8
Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice
Placebo Comparator: Control
White rice test meal boiled in 356 g water without gellan gum (50 g of available carbohydrate). Consumed on Day 1 at the study site, then consumed at home once daily for 7 days, then consumed again once at test site at Day 8
185 g Jasmine (white) rice boiled in 356 g water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of post prandial 2 hour circulating blood glucose curve
Time Frame: Over 2 hours post consumption
Fingerprick blood glucose profile for 2 hours post consumption of test rice samples.
Over 2 hours post consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of post prandial 3.5 hour circulating blood glucose curve
Time Frame: Over 3.5 hours post consumption
Fingerprick blood glucose profile for 3.5 hours post consumption of test rice samples rs
Over 3.5 hours post consumption
Time to Peak of blood glucose
Time Frame: Time period (during the 3.5 hour study period) until peak occurs in hours
Fingerprick blood glucose time to peak
Time period (during the 3.5 hour study period) until peak occurs in hours
Peak blood glucose
Time Frame: During the 3.5 hour period of the study.
Fingerprick blood glucose peak value
During the 3.5 hour period of the study.
Appetite scores post prandial up to 3.5 hours up to 3.5 hours
Time Frame: Over 3.5 hours
Curve of Visual Analogue Scores up to 3.5 hours postprandially
Over 3.5 hours
Gastrointestinal tolerance scores up to 3.5 hours
Time Frame: Over 3.5 hours
Symptom scores up to 3.5 hours postprandially
Over 3.5 hours
Total amount of energy consumed on the first day
Time Frame: Over 24 hours
Food intake measured from food diaries
Over 24 hours
Explorative correlations
Time Frame: Over 2 hours and over 3.5 hours
Explorative correlations between Fingerprick blood glucose area under the curve for 2 hours and 3.5 hours and respectively Area under the curve of appetite Visual Analogue Scores up to 2 hours and 3.5 hours postprandially
Over 2 hours and over 3.5 hours
Daily appetite scores measured using visual analogue scales
Time Frame: Daily for 7 days
Appetite score recorded twice daily morning and evening for 7 days using 100mm visual analogue scales with a minimum value of 0mm and maximum value of 100mm.
Daily for 7 days
Gastrointestinal tolerance visual analogue scores questionnaire
Time Frame: Daily for 7 days
Symptom scores measured daily over 7 days using 100mm visual analogue scales with 0mm as as the minimum and 100mm as the maximum.
Daily for 7 days
Gastrointestinal tolerance categorical questionnaire
Time Frame: Daily for 7 days
Symptom scores measured daily over 7 days using categorial scores with 0 as as the minimum and 3 as the maximum.
Daily for 7 days
Daily total amount of energy consumed
Time Frame: Daily for 7 days
Food intake measured from food diaries daily for 7 days
Daily for 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Moira A Taylor, PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 414-1121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing will be available after publication

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Access on demand

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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