Glycemic Response to Feeding in Healthy ParticipantsWIGGNCT05080400
White Rice and Effect of Gellan Gum on Glucose Responses by MRI
A study testing White rice and Gellan gum in people with Glycemic Response to Feeding in Healthy Participants, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response to Feeding in Healthy Participants
- What is being tested?
- White rice and Gellan gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2021to 22 Nov 2021
- 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
- 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)
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Disases Centre , University of Nottingham
Nottingham, NG7 2UH
About this study
Official title: Effects of Gellan Gum on the Glycemic, Gastrointestinal and Appetitive Responses to a White Rice Meal Assessed by MRI
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.
Read the 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:
- 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.
- Being tested
- White rice, Gellan gum
- Keywords
- white rice, glycemia, gellan gum, hydrocolloids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White riceDietary supplement
Jasmine rice 179g of cooked weight
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 | Experimental | White rice cooked with gellan gum Receives: Dietary Supplement: White rice; Dietary Supplement: Gellan gum |
| Control | Placebo comparator | White rice cooked without gellan gum Receives: Dietary Supplement: White rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the Curve of post prandial blood glucose up to 2h (iAUC2h)
Fingerprick blood glucose area under the curve for 2 hours
Measured: 2 hours
Secondary outcomes (2)
Ad libitum objective pasta meal at the end of the study day
Weighted amount of ad libitum pasta meal consumed at end of study morning
Measured: 3 hours
Under the Curve for appetite scores post prandial up to 2 hours (AUC2h)
Area under the curve of Visual Analogue Scores up to 2 hours postprandially
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start14 Jul 2021
- Primary completion27 Oct 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic Response to Feeding in Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 2-way crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Luca Marciani, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080400
- Sponsor's protocol ID
- 470-2001
- Acronym
- WIGG
- Status last verified
- Nov 2021
- First submitted
- 11 Aug 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gellan Gum on the Glycemic, Gastrointestinal and Appetitive Responses to a White Rice Meal Assessed by MRI
- ClinicalTrials.gov ID
- NCT05080400
- Acronym / sponsor ID
- WIGG / 470-2001
- Keywords
- white rice, glycemia, gellan gum, hydrocolloids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 15 Oct 2021 (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.
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.
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:
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomised 2-way crossover study
| Arm | Type | Receives |
|---|---|---|
| Gellan gum | Experimental | Dietary Supplement: White rice, Dietary Supplement: Gellan gumWhite rice cooked with gellan gum |
| Control | Placebo comparator | Dietary Supplement: White riceWhite rice cooked without gellan gum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (18 listed)
- 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.
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 riceJasmine rice 179g of cooked weight | Dietary supplement | Control, Gellan gum |
| Gellan gumFood grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice | Dietary supplement | Gellan gum |
Primary outcome
Incremental Area Under the Curve of post prandial blood glucose up to 2h (iAUC2h)
Time frame: 2 hours
Fingerprick blood glucose area under the curve for 2 hours
2 secondary outcomes
Ad libitum objective pasta meal at the end of the study day
Time frame: 3 hours
Under the Curve for appetite scores post prandial up to 2 hours (AUC2h)
Time frame: 2 hours
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 29 Nov 2021.
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Glycemic Response to Feeding in Healthy Participants, Postprandial Amino Acid Concentrations
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glycemic Response to Feeding in Healthy Participants, run by University of Nottingham 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 3 inclusion and 18 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 29 Nov 2021. 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?
Incremental Area Under the Curve of post prandial blood glucose up to 2h (iAUC2h) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2021.