Prediabetes
Conditions
Keywords
glycemic response, enzymatic conversion, gluconate
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 reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study
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 a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice. The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.
Interventions
OTHER500 ml glucose-depleted apple juice
OTHER500 ml conventional apple juice
OTHER250 ml glucose-depleted apple juice
OTHER250 ml conventional apple juice
Sponsors
Nofima
Clinical Research Center Kiel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The test products (verum and control) are similar in flavour, color, texture, appearance and identical in packaging to ensure the double-blind, controlled design of the study.
Intervention model description
a double-blind randomised controlled cross-over trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males aged ≥ 18y 2. Impaired fasting glucose (IFG) 3. Written informed consent 4. Consent to collect stools and urine four times for three days
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. Subjects having participated in the study HB-RCT1-2015 4. Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food 5. Acute or chronic infections 6. Renal insufficiency 7. Gastrointestinal illness 8. No stools of type 5-7 of Bristol Stool Form Scale within the last week before inclusion 9. History of gastrointestinal surgery 10. Known fructose intolerance 11. Overt diabetes mellitus 12. Endocrine disorders 13. 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 14. History of hepatitis B and C 15. History of HIV infection 16. History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid) 17. Regular medical treatment including OTC, which may have impact on the study aims (e.g. gluconic acid-containing OTCs, antidiabetic drugs, laxatives etc.) 18. Major cognitive or psychiatric disorders 19. Subjects who are scheduled to undergo hospitalization during the study period 20. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian) 21. Present drug abuse or alcoholism 22. Legal incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iAUC glucose 500 | 120 min after ingestion | Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice |
| iAUC insulin 500 | 120 min after ingestion | iAUC insulin 500 |
| iAUC glucose 250 | 120 min after ingestion | Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice |
| iAUC insulin 250 | 120 min after ingestion | iAUC insulin 250 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diarrhea | before and 60 and 120 minutes after ingestion with respect to the last 2 hours | Occurrence of diarrhoea as assessed by stool frequency and Bristol Stool Forms Scale (Lewis, 1997) (3 or more loose or liquid stools per day, definition according to the WHO) |
| gastro-intestinal symptoms | before and 60 and 120 minutes after ingestion with respect to the last 2 hours | Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998) |
Countries
Germany
Outcome results
None listed