White Rice and Gellan Gum 7 Days Intervention

NCT ID: NCT05713227

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised crossover placebo controlled
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Gellan gum

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

White rice

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

White rice

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

Intervention Type DIETARY_SUPPLEMENT

Gellan gum

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role collaborator

Moira Taylor

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Moira Taylor

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Moira A Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Garcia MC, Alfaro MC, Calero N, Munoz J. Influence of polysaccharides on the rheology and stabilization of alpha-pinene emulsions. Carbohydr Polym. 2014 May 25;105:177-83. doi: 10.1016/j.carbpol.2014.01.055. Epub 2014 Jan 27.

Reference Type BACKGROUND
PMID: 24708967 (View on PubMed)

Azadbakht L, Haghighatdoost F, Esmaillzadeh A. White Rice Consumption, Body Mass Index, and Waist Circumference among Iranian Female Adolescents. J Am Coll Nutr. 2016 Aug;35(6):491-499. doi: 10.1080/07315724.2015.1113902. Epub 2016 Jun 17.

Reference Type BACKGROUND
PMID: 27314887 (View on PubMed)

Golozar A, Khalili D, Etemadi A, Poustchi H, Fazeltabar A, Hosseini F, Kamangar F, Khoshnia M, Islami F, Hadaegh F, Brennan P, Boffetta P, Abnet CC, Dawsey SM, Azizi F, Malekzadeh R, Danaei G. White rice intake and incidence of type-2 diabetes: analysis of two prospective cohort studies from Iran. BMC Public Health. 2017 Jan 31;17(1):133. doi: 10.1186/s12889-016-3999-4.

Reference Type BACKGROUND
PMID: 28137245 (View on PubMed)

Mond JM, Myers TC, Crosby RD, Hay PJ, Rodgers B, Morgan JF, Lacey JH, Mitchell JE. Screening for eating disorders in primary care: EDE-Q versus SCOFF. Behav Res Ther. 2008 May;46(5):612-22. doi: 10.1016/j.brat.2008.02.003. Epub 2008 Feb 14.

Reference Type BACKGROUND
PMID: 18359005 (View on PubMed)

Yi Y, Jeon HJ, Yoon S, Lee SM. Hydrocolloids Decrease the Digestibility of Corn Starch, Soy Protein, and Skim Milk and the Antioxidant Capacity of Grape Juice. Prev Nutr Food Sci. 2015 Dec;20(4):276-83. doi: 10.3746/pnf.2015.20.4.276. Epub 2015 Dec 31.

Reference Type BACKGROUND
PMID: 26770915 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

414-1121

Identifier Type: -

Identifier Source: org_study_id