Clinical trial NCT02542033: Glycemic Response to Low Sugar Apple Juice
Official title: Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Fasting Glucose
Keywords: postprandial glycemia; apple juice; sugar reduction
Lead sponsor: Clinical Research Center Kiel GmbH
Sponsor class: OTHER
Collaborators: name: Nofima
First posted: 2015-09-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: incremental area under the postprandial glucose curve
timeFrame: 120 min postprandially
Secondary outcomes:
measure: incremental area under the postprandial insulin curve
timeFrame: 120 min postprandially
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Clinical Research Center (CRC) Kiel GmbH
state: Schleswig-Holstein
Study officials:
References: