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Completed

NCT Number: NCT05713227

White Rice and Gellan Gum 7 Days Intervention

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, Nottinghamshire, Ng7 2RD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

White Rice

Dietary Supplement

185 g Jasmine (white) rice boiled in 356 g water

Gellan gum

Dietary Supplement

Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Peak blood glucose

    Time frame: During the 3.5 hour period of the study.

    Fingerprick blood glucose peak value

  4. 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

  5. Gastrointestinal tolerance scores up to 3.5 hours

    Time frame: Over 3.5 hours

    Symptom scores up to 3.5 hours postprandially

  6. Total amount of energy consumed on the first day

    Time frame: Over 24 hours

    Food intake measured from food diaries

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. Daily total amount of energy consumed

    Time frame: Daily for 7 days

    Food intake measured from food diaries daily for 7 days

Sponsors and collaborators

Lead sponsor

Moira Taylor

Other

Collaborators

  • Imam Abdulrahman Bin Faisal University
  • University of Copenhagen

Registry information

Official study title

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

Acronym: WIGG2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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