Impaired Fasting Glucose
Conditions
Keywords
postprandial glycemia; apple juice; sugar reduction
Brief summary
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.
Detailed description
Objectives: Investigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink. Subjects/Methods: In a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (IFG) received an oral drink of 500mL: 1. Verum: Apple juice, treated (low sugar content); 2. Control: Untreated apple juice (normal sugar content). Capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.
Interventions
OTHERtreated apple juice with low sugar content
Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.
OTHERun-treated apple juice with normal sugar content
Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.
Sponsors
Nofima
Clinical Research Center Kiel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incremental area under the postprandial glucose curve | 120 min postprandially |
Secondary
| Measure | Time frame |
|---|---|
| incremental area under the postprandial insulin curve | 120 min postprandially |
Countries
Germany
Outcome results
None listed