HealthyWIGG2NCT05713227
White Rice and Gellan Gum 7 Days Intervention
A study testing White rice and Gellan gum in people with Healthy, run by Moira Taylor at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- White rice and Gellan gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jul 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, Ng7 2RD
About this study
Official 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- White rice, Gellan gum
- Keywords
- jasmine rice, white rice, gellan gum, glycemic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White riceDietary supplement
185 g Jasmine (white) rice boiled in 356 g water
Gellan gumDietary supplement
Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice
| Study group | Role | What they receive |
|---|---|---|
| Gellan gum | Active comparator | 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 Receives: Dietary Supplement: Gellan gum |
| Control | Placebo comparator | 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 Receives: Dietary Supplement: White rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of post prandial 2 hour circulating blood glucose curve
Fingerprick blood glucose profile for 2 hours post consumption of test rice samples.
Measured: Over 2 hours post consumption
Secondary outcomes (11)
Profile of post prandial 3.5 hour circulating blood glucose curve
Fingerprick blood glucose profile for 3.5 hours post consumption of test rice samples rs
Measured: Over 3.5 hours post consumption
Time to Peak of blood glucose
Fingerprick blood glucose time to peak
Measured: Time period (during the 3.5 hour study period) until peak occurs in hours
Peak blood glucose
Fingerprick blood glucose peak value
Measured: During the 3.5 hour period of the study.
Appetite scores post prandial up to 3.5 hours up to 3.5 hours
Curve of Visual Analogue Scores up to 3.5 hours postprandially
Measured: Over 3.5 hours
Gastrointestinal tolerance scores up to 3.5 hours
Symptom scores up to 3.5 hours postprandially
Measured: Over 3.5 hours
Total amount of energy consumed on the first day
Food intake measured from food diaries
Measured: Over 24 hours
Explorative correlations
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
Measured: Over 2 hours and over 3.5 hours
Daily appetite scores measured using visual analogue scales
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.
Measured: Daily for 7 days
Gastrointestinal tolerance visual analogue scores questionnaire
Symptom scores measured daily over 7 days using 100mm visual analogue scales with 0mm as as the minimum and 100mm as the maximum.
Measured: Daily for 7 days
Gastrointestinal tolerance categorical questionnaire
Symptom scores measured daily over 7 days using categorial scores with 0 as as the minimum and 3 as the maximum.
Measured: Daily for 7 days
Daily total amount of energy consumed
Food intake measured from food diaries daily for 7 days
Measured: Daily for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start11 Jul 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised crossover placebo controlled
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moira Taylor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Imam Abdulrahman Bin Faisal University
- Responsible party
- Sponsor-investigator, Moira Taylor, University of Nottingham
- Investigators
- Moira A Taylor, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713227
- Sponsor's protocol ID
- 414-1121
- Acronym
- WIGG2
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be available after publication
Publications
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.
PubMed 24708967Azadbakht L, Haghighatdoost F, Esmaillzadeh A; New Collective Author. 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.
PubMed 27314887Golozar 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.
PubMed 28137245Mond 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.
PubMed 18359005Yi 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.
PubMed 26770915
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05713227
- Acronym / sponsor ID
- WIGG2 / 414-1121
- Conditions
- Healthy
- Keywords
- jasmine rice, white rice, gellan gum, glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Moira TaylorUniversity, hospital or other
- Collaborators
- University of Copenhagen, Imam Abdulrahman Bin Faisal University
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised crossover placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Gellan gum | Active comparator | Dietary Supplement: Gellan gumWhite 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 |
| Control | Placebo comparator | Dietary Supplement: White riceWhite 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White rice185 g Jasmine (white) rice boiled in 356 g water | Dietary supplement | Control |
| Gellan gumFood grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice | Dietary supplement | Gellan gum |
Primary outcome
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.
11 secondary outcomes
Profile of post prandial 3.5 hour circulating blood glucose curve
Time frame: 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
Peak blood glucose
Time frame: 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
Gastrointestinal tolerance scores up to 3.5 hours
Time frame: Over 3.5 hours
Total amount of energy consumed on the first day
Time frame: Over 24 hours
Explorative correlations
Time frame: Over 2 hours and over 3.5 hours
Daily appetite scores measured using visual analogue scales
Time frame: Daily for 7 days
Gastrointestinal tolerance visual analogue scores questionnaire
Time frame: Daily for 7 days
Gastrointestinal tolerance categorical questionnaire
Time frame: Daily for 7 days
Daily total amount of energy consumed
Time frame: Daily for 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 24708967Garcia 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.
- Background: PubMed 27314887Azadbakht L, Haghighatdoost F, Esmaillzadeh A; New Collective Author. 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.
- Background: PubMed 28137245Golozar 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.
- Background: PubMed 18359005Mond 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.
- Background: PubMed 26770915Yi 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.
- Individual participant dataSharing planned: Yes. Data sharing will be available after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moira A Taylor, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White rice and Gellan gum in people with Healthy, run by Moira Taylor at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of post prandial 2 hour circulating blood glucose curve (time frame: Over 2 hours post consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713227, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.