NCT05080400

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

August 11, 2021

Last Update Submit

November 26, 2021

Conditions

Keywords

white riceglycemiagellan gumhydrocolloids

Outcome Measures

Primary Outcomes (1)

  • Incremental Area Under the Curve of post prandial blood glucose up to 2h (iAUC2h)

    Fingerprick blood glucose area under the curve for 2 hours

    2 hours

Secondary Outcomes (2)

  • Ad libitum objective pasta meal at the end of the study day

    3 hours

  • Under the Curve for appetite scores post prandial up to 2 hours (AUC2h)

    2 hours

Other Outcomes (6)

  • Time to Peak of blood glucose

    2 hours

  • Peak blood glucose

    2 hours

  • Area Under the Curve of post prandial gastric volumes up to 2h (AUC2h)

    2 hours

  • +3 more other outcomes

Study Arms (2)

Gellan gum

EXPERIMENTAL

White rice cooked with gellan gum

Dietary Supplement: White riceDietary Supplement: Gellan gum

Control

PLACEBO COMPARATOR

White rice cooked without gellan gum

Dietary Supplement: White rice

Interventions

White riceDIETARY_SUPPLEMENT

Jasmine rice 179g of cooked weight

ControlGellan gum
Gellan gumDIETARY_SUPPLEMENT

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

Gellan gum

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Digestive Disases Centre , University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

gellan gum

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant blind to cooking process
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: randomised 2-way crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Gastrointestinal Imaging

Study Record Dates

First Submitted

August 11, 2021

First Posted

October 15, 2021

Study Start

July 14, 2021

Primary Completion

October 27, 2021

Study Completion

November 22, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations