Glycemic Response to Low Sugar Apple Juice

Impaired Fasting Glucose Clinical Trial

Official title:

Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542033
• Other study ID #: HB-RCT1-2015
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Clinical Research Center Kiel GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Impaired Fasting Glucose

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Clinical Research Center (CRC) Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Center Kiel GmbH	Nofima

Country where clinical trial is conducted

Germany, 

Outcome

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