Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.

NCT ID: NCT03552315

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2018-09-05

Brief Summary

It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.

Conditions

Postprandial Hyperglycemia; Metabolic Syndrome; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Water with amino acids and chromium

The carbonated water with a proprietary blend of five amino acids and chromium picolinate is consumed with a standardized test meal to study its effects on glucose and insulin responses.

Group Type: ACTIVE_COMPARATOR

Carbonated water with amino acids and chromium

Intervention Type: DIETARY_SUPPLEMENT

The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes

Carbonated water

The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses.

Group Type: PLACEBO_COMPARATOR

Placebo Carbonated Water

Intervention Type: DIETARY_SUPPLEMENT

The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes

Interventions

Carbonated water with amino acids and chromium

The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes

Intervention Type: DIETARY_SUPPLEMENT

Placebo Carbonated Water

The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male or female 18 to 50 years of age
• BMI 25-29.9 (±0.5) kg/m²
• Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
• Healthy as determined by medical history and information provided by the volunteer
• Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
• Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria

• Elevated fasting blood glucose (at or above 6.1 mmol/L)
• Women who are pregnant or breast feeding
• Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
• Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the qualified investigator (QI). Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
• Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
• Use of antibiotics within 2 weeks of enrollment
• Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
• Allergy to ingredients included in investigational product, placebo or standardized meal
• Participants restricted to a vegetarian or vegan diet
• Intolerance to lactose or gluten
• Individuals who are averse to venous catheterization or capillary blood sampling
• Currently active smokers (or using other tobacco products, and e-cigarettes)
• Unstable medical conditions as determined by QI
• Participation in other clinical research trials
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Acute infection
• Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

DoubleGood AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina E Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University and Aventure AB

Locations

Dept Experimental Medical Science, Lund University

Lund, , Sweden

Countries

Sweden

Other Identifiers

DG1802

Identifier Type: -

Identifier Source: org_study_id