Glycemic Response to Two Doses of Low Sugar Apple Juice

NCT04747639 | Completed DMC

• 1 other identifier: HB-RCT2-2015
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study

Conditions

Prediabetes

Keywords

glycemic response, enzymatic conversion, gluconate

Outcome Measures

Primary Outcomes (4)

• iAUC glucose 500

  Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice

  120 min after ingestion

• iAUC insulin 500

  iAUC insulin 500

  120 min after ingestion

• iAUC glucose 250

  Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice

  120 min after ingestion

• iAUC insulin 250

  iAUC insulin 250

  120 min after ingestion

Secondary Outcomes (2)

• diarrhea

  before and 60 and 120 minutes after ingestion with respect to the last 2 hours

• gastro-intestinal symptoms

  before and 60 and 120 minutes after ingestion with respect to the last 2 hours

Study Arms (4)

verum 500

ACTIVE COMPARATOR

500 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l.

Other: 500 ml glucose-depleted apple juice

control 500

PLACEBO COMPARATOR

500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)

Other: 500 ml conventional apple juice

verum 250

ACTIVE COMPARATOR

250 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l.

Other: 250 ml glucose-depleted apple juice

control 250

PLACEBO COMPARATOR

250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)

Other: 250 ml conventional apple juice

Interventions

500 ml glucose-depleted apple juice OTHER

verum 500

500 ml conventional apple juice OTHER

control 500

250 ml glucose-depleted apple juice OTHER

verum 250

250 ml conventional apple juice OTHER

control 250

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
• Impaired fasting glucose (IFG)
• Written informed consent
• Consent to collect stools and urine four times for three days

You may not qualify if:

• Subjects currently enrolled in another clinical study
• Subjects having participated in the study HB-RCT1-2015
• 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. gluconic acid-containing OTCs, antidiabetic drugs, laxatives etc.)
• Major cognitive or psychiatric disorders

Sponsors & Collaborators

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

Study Sites (1)

CRC Clinical Research Center Kiel

Kiel, Schleswig-Holstein, 24118, Germany

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christiane Laue, Dr. (MD)

  CRC Clinical Research Center Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The test products (verum and control) are similar in flavour, color, texture, appearance and identical in packaging to ensure the double-blind, controlled design of the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a double-blind randomised controlled cross-over trial

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: October 28, 2015
• Primary Completion: May 9, 2016
• Study Completion: February 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)