Glycemic Response to Low Sugar Apple Juice

NCT02542033 | Completed

• 1 other identifier: HB-RCT1-2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Fasting Glucose

Keywords

postprandial glycemia; apple juice; sugar reduction

Outcome Measures

Primary Outcomes (1)

• incremental area under the postprandial glucose curve

  120 min postprandially

Secondary Outcomes (1)

• incremental area under the postprandial insulin curve

  120 min postprandially

Study Arms (2)

verum

ACTIVE COMPARATOR

500mL treated apple juice with low sugar content given on one experimental day

Other: treated apple juice with low sugar content

control

PLACEBO COMPARATOR

500mL un-treated apple juice with normal sugar content given on one experimental day

Other: un-treated apple juice with normal sugar content

Interventions

treated apple juice with low sugar content OTHER

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.

verum

un-treated apple juice with normal sugar content OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged ≥ 18y
• diagnosed impaired fasting glucose (IFG)
• Written informed consent

You may not qualify if:

• Subjects currently enrolled in another clinical study
• Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
• Acute or chronic infections
• Renal insufficiency
• Gastrointestinal illness
• History of gastrointestinal surgery
• Known fructose intolerance
• Overt Diabetes mellitus
• Endocrine disorders
• History of hepatitis B and C
• History of HIV infection
• History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
• Regular medical treatment including OTC, which may have impact on the study aims (e.g. antidiabetic drugs, laxatives etc.)
• Major cognitive or psychiatric disorders
• Subjects who are scheduled to undergo hospitalization during the study period

Sponsors & Collaborators

• Clinical Research Center Kiel GmbH: lead
• Nofima: collaborator

Study Sites (1)

Clinical Research Center (CRC) Kiel GmbH

Kiel, Schleswig-Holstein, 24118, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 4, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 11, 2021

Record last verified: 2015-09

Locations

DE (1)