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

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ClinicalTrials.gov Identifier: NCT03552315
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
DoubleGood AB

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.

Condition or disease Intervention/treatment Phase
Postprandial Hyperglycemia Metabolic Syndrome Type 2 Diabetes Mellitus Dietary Supplement: Carbonated water with amino acids and chromium Dietary Supplement: Placebo Carbonated Water Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : November 30, 2018


Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: 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

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




Primary Outcome Measures :
  1. The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes [ Time Frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal ]
    The incremental area under the curve for capillary blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.


Secondary Outcome Measures :
  1. The three-hour iAUC for insulin, 0-180 minutes [ Time Frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal ]
    The incremental area under the curve for intravenous blood insulin will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.

  2. The three hour iAUC for intravenous glucose, 0-180 minutes [ Time Frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal ]
    The incremental area under the curve for intravenous blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.

  3. The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes [ Time Frame: 0, 15, 30, 45 and 60 minutes post test meal ]
    The incremental area under the curve for intravenous blood GLP-1 will be measured within 60 minutes after a test meal. Blood samples will be collected at 5 time points during the 60 minutes.


Other Outcome Measures:
  1. The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin [ Time Frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal ]
    Blood samples will be collected at 8 time points during the 180 minutes.

  2. The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin [ Time Frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal ]
    Blood samples will be collected at 8 time points during the 180 minutes.

  3. The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin [ Time Frame: 0, 15, 30, 45, 60, 90 and 120 minutes post test meal ]
    Blood samples will be collected at 7 time points during the 120 minutes.

  4. The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin [ Time Frame: 0, 15, 30, 45 and 60 minutes post test meal ]
    Blood samples will be collected at 5 time points during the 60 minutes.

  5. Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood. [ Time Frame: 0 and 60 minutes post test meal ]
    A delta value will be calculated from samples collected at time=0 and time=60 minutes

  6. Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood. [ Time Frame: 0 and 120 minutes post test meal ]
    A delta value will be calculated from samples collected at time=0 and time=120 minutes



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552315


Contacts
Contact: Kristina E Andersson, PhD +46 709 307357 kristina_e.andersson@med.lu.se

Locations
Sweden
Dept Experimental Medical Science, Lund University Recruiting
Lund, Sweden
Contact: Kristina E Andersson, PhD    +46 709 307357    kristina_e.andersson@med.lu.se   
Sponsors and Collaborators
DoubleGood AB
Lund University
Investigators
Principal Investigator: Kristina E Andersson, PhD Lund University and Aventure AB

Responsible Party: DoubleGood AB
ClinicalTrials.gov Identifier: NCT03552315     History of Changes
Other Study ID Numbers: DG1802
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Insulin, Globin Zinc
Insulin
Chromium
Picolinic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action