Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-05-31
2015-11-30
Brief Summary
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Exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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verum
500mL treated apple juice with low sugar content given on one experimental day
treated 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.
control
500mL un-treated apple juice with normal sugar content given on one experimental day
un-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.
Interventions
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treated 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.
un-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.
Eligibility Criteria
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Inclusion Criteria
2. diagnosed impaired fasting glucose (IFG)
3. Written informed consent
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
Exclusion Criteria
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
18 Years
MALE
No
Sponsors
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Nofima
OTHER
Clinical Research Center Kiel GmbH
OTHER
Responsible Party
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Locations
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Clinical Research Center (CRC) Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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HB-RCT1-2015
Identifier Type: -
Identifier Source: org_study_id
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