Clinical trial NCT03552315: Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover, Single-center, Proof of Concept Study to Evaluate the Efficacy of GoodIdea® on Glucose Homeostasis in a Healthy Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Metabolic Syndrome
Type 2 Diabetes Mellitus
Lead sponsor: DoubleGood AB
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2018-06-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
timeFrame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Secondary outcomes:
measure: The three-hour iAUC for insulin, 0-180 minutes
timeFrame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
measure: The three hour iAUC for intravenous glucose, 0-180 minutes
timeFrame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
measure: The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes
timeFrame: 0, 15, 30, 45 and 60 minutes post test meal
Other outcomes:
measure: The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin
timeFrame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
measure: The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin
timeFrame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
measure: The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin
timeFrame: 0, 15, 30, 45, 60, 90 and 120 minutes post test meal
measure: The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin
timeFrame: 0, 15, 30, 45 and 60 minutes post test meal
measure: Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood.
timeFrame: 0 and 60 minutes post test meal
measure: Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood.
timeFrame: 0 and 120 minutes post test meal
Locations:
city: Lund
country: Sweden
facility: Dept Experimental Medical Science, Lund University
Study officials:
affiliation: Lund University and Aventure AB
name: Kristina E Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: