NCT05713227

Brief 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). This study will explore whether such a modification in response is sustained, particularly over a period of 7 days of consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

December 6, 2022

Last Update Submit

November 27, 2023

Conditions

Healthy

Keywords

jasmine ricewhite ricegellan gumglycemic response

Outcome Measures

Primary Outcomes (1)

  • Profile of post prandial 2 hour circulating blood glucose curve

    Fingerprick blood glucose profile for 2 hours post consumption of test rice samples.

    Over 2 hours post consumption

Secondary Outcomes (11)

  • Profile of post prandial 3.5 hour circulating blood glucose curve

    Over 3.5 hours post consumption

  • Time to Peak of blood glucose

    Time period (during the 3.5 hour study period) until peak occurs in hours

  • Peak blood glucose

    During the 3.5 hour period of the study.

  • Appetite scores post prandial up to 3.5 hours up to 3.5 hours

    Over 3.5 hours

  • Gastrointestinal tolerance scores up to 3.5 hours

    Over 3.5 hours

  • +6 more secondary outcomes

Study Arms (2)

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

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

Dietary Supplement: White rice

Interventions

White riceDIETARY_SUPPLEMENT

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

Control
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:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, Ng7 2RD, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 24708967BACKGROUND

  • 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.

    PMID: 27314887BACKGROUND

  • 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.

    PMID: 28137245BACKGROUND

  • 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.

    PMID: 18359005BACKGROUND

  • 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.

    PMID: 26770915BACKGROUND

MeSH Terms

Interventions

gellan gum

Study Officials

  • Moira A Taylor, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised crossover placebo controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 6, 2022

First Posted

February 6, 2023

Study Start

July 11, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Data sharing will be available after publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication
Access Criteria
Access on demand

Locations

GB(1)