Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™

NCT03375398 | Completed

• 1 other identifier: PAZ320-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was a partly controlled laboratory-based study comparing the short-term postprandial blood glucose and insulin responses produced by 3 test meals containing white rice alone or with SUGARDOWN™ (Galactomannan) in overweight adults.

Conditions

Postprandial Hyperglycemia

Keywords

SUGARDOWN™; Galactomannan; Postprandial blood glucose; Insulin

Outcome Measures

Primary Outcomes (1)

• Postprandial increment glucose under the area curve (iAUC)

  Blood samples were collected into a micro-centrifuge tube containing the anticoagulant, heparin sodium salt. Plasma glucose concentrations were measured in duplicate using a spectrophotometric centrifugal analyser employing the glucose hexokinase/glucose-6-phosphate dehydrogenase enzymatic assay.

  2 days

Secondary Outcomes (1)

• Postprandial increment insulin under the area curve (iAUC)

  2 days

Study Arms (3)

3 tablets Sugardown™

EXPERIMENTAL

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 3 tablets Sugardown™

Dietary Supplement: Sugardown™

Rice only

PLACEBO COMPARATOR

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice

Dietary Supplement: Rice

6 tablets Sugardown™

EXPERIMENTAL

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 6 tablets Sugardown™

Dietary Supplement: Sugardown™

Interventions

Rice DIETARY_SUPPLEMENT

Test food #1: White Rice \<63.0 g (dry) Jasmine rice consumed together with 250 mL water

Also known as: BTI320, PAZ320

Rice only

Sugardown™ DIETARY_SUPPLEMENT

Test food #2: White Rice \< 63.0 g (dry) Jasmine rice + 3 Sugardown™ tablets consumed together with 250 mL water Test food #3: White Rice \< 63.0 g (dry) Jasmine rice + 6 Sugardown™ tablets consumed together with 250 mL water

Also known as: BTI320, PAZ320

3 tablets Sugardown™; 6 tablets Sugardown™

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 25-65 years.
• Non-smoker.
• Stable body weight within the overweight weight range for their height (BMI values \> 25 kg/m2).
• Normal dietary habits; not dieting or eating in an overly restrictive fashion in the past 3 months.
• A regular pattern of low to moderate physical activity.
• Able to fast for ≥ 10 hours the night before each test session.
• Able to refrain from eating a legume-based evening meal or drinking alcohol the day before each test session.
• Finds the test foods suitable for consumption within 12 minutes.
• Participant covered by social security or a similar system.
• Not taking any treatment for anorexia, weight loss, or any form of treatment or medication likely to interfere with metabolism or dietary habits.
• Signed the informed consent form for the study.

You may not qualify if:

• Currently following a restrictive diet (low-calorie, low-carbohydrate, vegan).
• Any clinically significant physical or mental illness.
• Suffering from a food allergy or serious food intolerance.
• Regularly taking prescription medication other than standard contraceptive medication.
• Females who are currently pregnant, breast-feeding, trying to become pregnant or not using an acceptable contraceptive.
• Participating in another clinical trial or participated in another clinical trial within the last week.
• Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Sponsors & Collaborators

• Boston Therapeutics: lead

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Interventions

PAZ320

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Jennie Brand-Miller, Prof.

  Human Nutrition Unit School of Molecular Bioscience, University of Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: December 18, 2017
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 18, 2017

Record last verified: 2017-12