Impaired Fasting Glucose Clinical Trial
Official title:
Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice
NCT number | NCT02542033 |
Other study ID # | HB-RCT1-2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | November 2015 |
Verified date | September 2015 |
Source | Clinical Research Center Kiel GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response. Exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Males aged = 18y 2. diagnosed impaired fasting glucose (IFG) 3. Written informed consent Exclusion Criteria: 1. Subjects currently enrolled in another clinical study 2. Subjects having finished another clinical study within the last 4 weeks before inclusion 3. Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food 4. Acute or chronic infections 5. Renal insufficiency 6. Gastrointestinal illness 7. History of gastrointestinal surgery 8. Known fructose intolerance 9. Overt Diabetes mellitus 10. Endocrine disorders 11. 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 12. History of hepatitis B and C 13. History of HIV infection 14. History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid) 15. Regular medical treatment including OTC, which may have impact on the study aims (e.g. antidiabetic drugs, laxatives etc.) 16. Major cognitive or psychiatric disorders 17. Subjects who are scheduled to undergo hospitalization during the study period 18. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian) 19. Present drug abuse or alcoholism 20. Legal incapacity |
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Research Center (CRC) Kiel GmbH | Kiel | Schleswig-Holstein |
Lead Sponsor | Collaborator |
---|---|
Clinical Research Center Kiel GmbH | Nofima |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incremental area under the postprandial glucose curve | 120 min postprandially | ||
Secondary | incremental area under the postprandial insulin curve | 120 min postprandially |
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