Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism on Healthy Subjects

NCT02487680 | Completed

• 1 other identifier: DoubleGood Lund
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the curve for Glucose after ingestion of a test meal

  180 min

Secondary Outcomes (1)

• Area under the curve for insulin after ingestion of a test meal

  180 min

Study Arms (2)

Breakfast meal

EXPERIMENTAL

A breakfast like meal will be provided together with a drink to overnight fasted subjects

Dietary Supplement: Amino Acids and chromium-picolinate containing drink; Dietary Supplement: Placebo drink

Lunch meal

EXPERIMENTAL

A lunch like meal will be provided together with a drink to overnight fasted subjects

Dietary Supplement: Amino Acids and chromium-picolinate containing drink; Dietary Supplement: Placebo drink

Interventions

Amino Acids and chromium-picolinate containing drink DIETARY_SUPPLEMENT

Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma

Breakfast meal; Lunch meal

Placebo drink DIETARY_SUPPLEMENT

Evaluation of the placebo supplement drink containing only aroma

Breakfast meal; Lunch meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable body weight (no changes above 3 kg during the last 2 months)
• Good general health
• Body mass index 19 - 30 kg/m2 (normal to overweight)
• Fasting blood glucose below 6.1 mmol/L

You may not qualify if:

• Any medication that could influence the study. Such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia
• Psychiatric Disease
• Alcohol or drug abuse
• Smokers or people consuming snus
• Acute infections
• Vegetarians/vegans
• Suffering from Lactose or Gluten intolerance
• Pregnancy or Lactation
• Participation in another study at the same time
• Any other parameter that the PI will judge as inadequate

Sponsors & Collaborators

• DoubleGood AB: lead
• Lund University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Per Humpert, MD, Prof

  Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

• Ana Rascón, PhD, Prof

  Food for Health Science Center, Lund University, Sweden

  STUDY DIRECTOR

• Kristina Andersson, PhD

  Experimental Medical Science, Lund University, Sweden

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 12, 2017

Record last verified: 2017-05