Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™
NCT ID: NCT03374501
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2014-11-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
SUBJECTS Ten healthy, non-smoking, overweight or obese subjects (6 females and 4 males) voluntarily participated in this study. The mean ± SD age of the subjects was 32.4 ± 10.9 yr (range: 18.7 - 55.6 yr), and their mean ± body mass index value was 27.4 ± 2.6 kg/m2 (range: 25.3 - 32.3 kg/m2).
Volunteers were given detailed written and verbal information about all of the study's inclusion criteria and experimental procedures. If the volunteers decided that they would like to participate in the study, they were asked to come to the research centre on another morning, where they completed a detailed screening questionnaire that assessed their current health status and medical history. In order to participate in the study, the volunteers had to meet the inclusion criteria. All suitable volunteers that were invited to participate in the study were required to sign a detailed subject information sheet and a consent form before commencing any experimental procedures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2 tablets Sugardown™
Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™
Sugardown™
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)
4 tablets Sugardown™
Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™
Sugardown™
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)
Soft drink
Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink
Soft drink
Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sugardown™
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)
Soft drink
Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Undergoing general anaesthesia in the month prior to inclusion.
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennie Brand-Miller
Role: PRINCIPAL_INVESTIGATOR
School of Molecular Bioscience, University of Syndey, Australia
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PAZ320-004
Identifier Type: -
Identifier Source: org_study_id