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

NCT03552315 | Completed

• 1 other identifier: DG1802
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes

  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.

  0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

Secondary Outcomes (3)

• The three-hour iAUC for insulin, 0-180 minutes

  0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

• The three hour iAUC for intravenous glucose, 0-180 minutes

  0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

• The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes

  0, 15, 30, 45 and 60 minutes post test meal

Other Outcomes (6)

• The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin

  0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

• The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin

  0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

• The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin

  0, 15, 30, 45, 60, 90 and 120 minutes post test meal

Study Arms (2)

Water with amino acids and chromium

ACTIVE COMPARATOR

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

Carbonated water

PLACEBO COMPARATOR

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

Interventions

Carbonated water with amino acids and chromium 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

Water with amino acids and chromium

Placebo Carbonated Water DIETARY_SUPPLEMENT

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

Carbonated water

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DoubleGood AB: lead
• Lund University: collaborator

Study Sites (1)

Dept Experimental Medical Science, Lund University

Lund, Sweden

Location

MeSH Terms

Conditions

Hyperglycemia; Metabolic Syndrome; Diabetes Mellitus, Type 2

Interventions

Carbonated Water; Amino Acids; Chromium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mineral Waters; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Carbonated Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Drinking Water; Food and Beverages; Amino Acids, Peptides, and Proteins; Metals, Heavy; Elements; Transition Elements; Metals

Study Officials

• Kristina E Andersson, PhD

  Lund University and Aventure AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: June 11, 2018
• Study Start: April 24, 2018
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)