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Trial record 76 of 751 for:    Area Under Curve AND meal

Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.

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ClinicalTrials.gov Identifier: NCT03411395
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
Lund University
Aventure AB
Information provided by (Responsible Party):
DoubleGood AB

Brief Summary:
It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) within 180 minutes after ingestion of the meal.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 5AA+CrPic Water Other: Placebo drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 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 Study to Evaluate the Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo drink
A standardized breakfast meal will be provided together with carbonated water containing aroma
Other: Placebo drink
Placebo water with carbonation and aroma

Experimental: 5AA+CrPic Water Dose 1
A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic
Dietary Supplement: 5AA+CrPic Water
Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate
Other Name: Good Idea

Experimental: 5AA+CrPic Water Dose 2
A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic
Dietary Supplement: 5AA+CrPic Water
Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate
Other Name: Good Idea

Experimental: 5AA+CrPic Water Dose 3
A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic
Dietary Supplement: 5AA+CrPic Water
Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate
Other Name: Good Idea




Primary Outcome Measures :
  1. Blood glucose response [ Time Frame: 3h postprandial phase ]
    The difference in three-hour incremental area under the curve (AUC) for capillary blood glucose between 5AA+CrPic test products and placebo following a standardized breakfast meal.


Secondary Outcome Measures :
  1. Cmax of capillary blood glucose [ Time Frame: 3h postprandial phase ]
    The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between 5AA+CrPic test products and the placebo following a standardized meal.

  2. Serum insulin response [ Time Frame: 3h postprandial phase ]
    The difference of the three-hour iAUC (0 - 180 min) intravenous serum insulin iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

  3. Venous blood glucose response [ Time Frame: 3h postprandial phase ]
    The difference of the three-hour iAUC (0 - 180 min) intravenous plasma glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

  4. GLP-1 response [ Time Frame: 1h postprandial phase ]
    The difference of the 1h iAUC (0 - 60 min) intravenous blood glucagon-like peptide 1 (GLP-1) iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

  5. Capillary blood glucose response [ Time Frame: 2h postprandial phase ]
    The difference in the two-hour iAUC (0 - 120 min) capillary blood glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index 18-25 (±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:

  • Pregnancy or lactation
  • Known Type I or Type II diabetes
  • Undetected Type I or Type II diabetes (fasting blood glucose < 6.1 mmol/L at first test day)
  • Use of antibiotics
  • Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
  • Allergy to test product or placebo ingredients
  • Participants restricted to a vegetarian or vegan diet
  • Intolerance to lactose or gluten
  • Acute infection
  • Individuals who are averse to venous catheterization or capillary blood sampling
  • Alcohol or drug abuse
  • Currently active smokers (tobacco products, and e-cigarettes)
  • Participation in other clinical research trials
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the PI'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
  • Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the PI
  • 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 PI. 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.

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): NCT03411395


Sponsors and Collaborators
DoubleGood AB
Lund University
Aventure AB
Investigators
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Principal Investigator: Elin Östman, PhD Scheelevägen 22 223 63 Lund, Sweden
Study Director: Kristina Andersson, PhD Experimental Medical Science, Lund University, Sweden
Study Chair: Lovisa Heyman-Lindén, PhD Scheelevägen 22 223 63 Lund, Sweden

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Responsible Party: DoubleGood AB
ClinicalTrials.gov Identifier: NCT03411395     History of Changes
Other Study ID Numbers: DG1603Lund
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by DoubleGood AB:
Diabetes
Prediabetes
Blood sugar regulation