Completed

Amino Acid and Chromium Table Water Impact on Glucose Response in Type 2 Diabetes Patients

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Study Aim

This study investigates how amino acid and chromium table water affect glucose response in individuals with type 2 diabetes, by measuring the area under the curve for glucose within 180 minutes after a test meal.

What is being tested

Amino Acid and chromium-picolinate containing drink

+ Placebo Drink

Dietary Supplement
Who is being recruted

Diabetes Mellitus+4

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 70 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: August 2014
See protocol details

Summary

Principal SponsorStoffwechselzentrum Rhein - Pfalz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2014

Actual date on which the first participant was enrolled.

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 and insulin response. 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 patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. 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.

Official TitleInfluence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design
NCT02235194
Principal SponsorStoffwechselzentrum Rhein - Pfalz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPrediabetic StateGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Early Type 2 Diabetes (i.e. on Metformin or diet only)

Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)

HbA1c < 7%

BMI 28,0-39,9 kg/m²

10 exclusion criteria prevent from participating
Any antidiabetic medication other than metformin

Psychiatric Disease

Acute Infections

Alcohol or drug abuse

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.

Group II

Placebo
Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stoffwechselzentrum Rhein Pfalz

Mannheim, GermanyOpen Stoffwechselzentrum Rhein Pfalz in Google Maps
CompletedOne Study Center