Status:
COMPLETED
Glycemic Response to Two Doses of Low Sugar Apple Juice
Lead Sponsor:
Clinical Research Center Kiel GmbH
Collaborating Sponsors:
Nofima
Conditions:
Prediabetes
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the re...
Detailed Description
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the in...
Eligibility Criteria
Inclusion
- Males aged ≥ 18y
- Impaired fasting glucose (IFG)
- Written informed consent
- Consent to collect stools and urine four times for three days
Exclusion
- Subjects currently enrolled in another clinical study
- Subjects having finished another clinical study within the last 4 weeks before inclusion.
- Subjects having participated in the study HB-RCT1-2015
- Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- Acute or chronic infections
- Renal insufficiency
- Gastrointestinal illness
- No stools of type 5-7 of Bristol Stool Form Scale within the last week before inclusion
- History of gastrointestinal surgery
- Known fructose intolerance
- Overt diabetes mellitus
- Endocrine disorders
- Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria
- History of hepatitis B and C
- History of HIV infection
- History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
- Regular medical treatment including OTC, which may have impact on the study aims (e.g. gluconic acid-containing OTCs, antidiabetic drugs, laxatives etc.)
- Major cognitive or psychiatric disorders
- Subjects who are scheduled to undergo hospitalization during the study period
- Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
- Present drug abuse or alcoholism
- Legal incapacity
Key Trial Info
Start Date :
October 28 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04747639
Start Date
October 28 2015
End Date
February 1 2021
Last Update
August 4 2021
Active Locations (1)
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1
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, Germany, 24118