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NCT Number: NCT02542033

Glycemic Response to Low Sugar Apple Juice

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.

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Key information

Conditions

Impaired Fasting Glucose

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center (CRC) Kiel GmbH

Kiel, Schleswig-Holstein, 24118, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects currently enrolled in another clinical study
  • Subjects having finished another clinical study within the last 4 weeks before inclusion
  • 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
  • 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
  • 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
  • Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
  • Present drug abuse or alcoholism
  • Legal incapacity

Treatment and study plan

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.

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.

Primary outcomes

  1. incremental area under the postprandial glucose curve

    Time frame: 120 min postprandially

Secondary outcomes

  1. incremental area under the postprandial insulin curve

    Time frame: 120 min postprandially

Sponsors and collaborators

Lead sponsor

Clinical Research Center Kiel GmbH

Other

Collaborators

  • Nofima

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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