Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™

NCT03374501 | Completed

• 1 other identifier: PAZ320-004
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was a partly controlled laboratory-based study comparing the glycemic and insulinemic indices of 3 test meals containing soft drink alone or with SUGARDOWN™ (Galactomannan) in overweight adults.

Conditions

Postprandial Hyperglycemia

Keywords

Sugardown™; Galactomannan; Postprandial blood glucose; Insulin

Outcome Measures

Primary Outcomes (1)

• Glycemic index of the three test meals.

  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)

• Insulinemic index of the three test meals.

  2 days

Study Arms (3)

2 tablets Sugardown™

EXPERIMENTAL

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™

Dietary Supplement: Sugardown™

4 tablets Sugardown™

EXPERIMENTAL

Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™

Dietary Supplement: Sugardown™

Soft drink

PLACEBO COMPARATOR

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

Dietary Supplement: Soft drink

Interventions

Sugardown™ DIETARY_SUPPLEMENT

Test food #2: 495.0 g Sprite™ soft drink plus 2 Sugardown™ tablet consumed with 250 mL water (repeated twice) Test food #3: 495.0 g Sprite™ soft drink plus 4 Sugardown™ tablet consumed with 250 mL water (repeated twice)

Also known as: BTI320, PAZ320

2 tablets Sugardown™; 4 tablets Sugardown™

Soft drink DIETARY_SUPPLEMENT

Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)

Also known as: Sprite™

Soft drink

Eligibility Criteria

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

You may qualify if:

• Aged between 18-65 years.
• Non-smoker.
• Stable body weight within the overweight weight range for their height (BMI values 25 kg/m2 for Causcasian individuals and \>23 kg/m2 for Asian individuals).
• 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.
• 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 two weeks.
• 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; Carbonated Beverages

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jennie Brand-Miller

  School of Molecular Bioscience, University of Syndey, 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: December 12, 2017
• First Posted: December 15, 2017
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 15, 2017

Record last verified: 2017-12