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Glycemic Response to Two Doses of Low Sugar Apple Juice (HB-RCT2-2015)

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
500 ml glucose-depleted apple juice
500 ml conventional apple juice
250 ml glucose-depleted apple juice
250 ml conventional apple juice
Sponsored by
Clinical Research Center Kiel GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prediabetes focused on measuring glycemic response, enzymatic conversion, gluconate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males aged ≥ 18y
  2. Impaired fasting glucose (IFG)
  3. Written informed consent
  4. Consent to collect stools and urine four times for three days

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. Subjects having participated in the study HB-RCT1-2015
  4. Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
  5. Acute or chronic infections
  6. Renal insufficiency
  7. Gastrointestinal illness
  8. No stools of type 5-7 of Bristol Stool Form Scale within the last week before inclusion
  9. History of gastrointestinal surgery
  10. Known fructose intolerance
  11. Overt diabetes mellitus
  12. Endocrine disorders
  13. 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
  14. History of hepatitis B and C
  15. History of HIV infection
  16. History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
  17. Regular medical treatment including OTC, which may have impact on the study aims (e.g. gluconic acid-containing OTCs, antidiabetic drugs, laxatives etc.)
  18. Major cognitive or psychiatric disorders
  19. Subjects who are scheduled to undergo hospitalization during the study period
  20. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
  21. Present drug abuse or alcoholism
  22. Legal incapacity

Sites / Locations

  • CRC Clinical Research Center Kiel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

verum 500

control 500

verum 250

control 250

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

iAUC glucose 500
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
iAUC insulin 500
iAUC insulin 500
iAUC glucose 250
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
iAUC insulin 250
iAUC insulin 250

Secondary Outcome Measures

diarrhea
Occurrence of diarrhoea as assessed by stool frequency and Bristol Stool Forms Scale (Lewis, 1997) (3 or more loose or liquid stools per day, definition according to the WHO)
gastro-intestinal symptoms
Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998)

Full Information

First Posted
February 5, 2021
Last Updated
August 3, 2021
Sponsor
Clinical Research Center Kiel GmbH
Collaborators
Nofima
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1. Study Identification

Unique Protocol Identification Number
NCT04747639
Brief Title
Glycemic Response to Two Doses of Low Sugar Apple Juice
Acronym
HB-RCT2-2015
Official Title
Double-blind, Randomized, Controlled, Four Treatment Four Period Cross-over Trial on Glycemic Response, Excretion of Gluconate and Tolerability of Two Doses of Low Sugar Apple Juice
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2015 (Actual)
Primary Completion Date
May 9, 2016 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Center Kiel GmbH
Collaborators
Nofima

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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 in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice. The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
glycemic response, enzymatic conversion, gluconate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
a double-blind randomised controlled cross-over trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verum 500
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control 500
Arm Type
Placebo Comparator
Arm Description
500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
Arm Title
verum 250
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control 250
Arm Type
Placebo Comparator
Arm Description
250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
Intervention Type
Other
Intervention Name(s)
500 ml glucose-depleted apple juice
Intervention Type
Other
Intervention Name(s)
500 ml conventional apple juice
Intervention Type
Other
Intervention Name(s)
250 ml glucose-depleted apple juice
Intervention Type
Other
Intervention Name(s)
250 ml conventional apple juice
Primary Outcome Measure Information:
Title
iAUC glucose 500
Description
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
Time Frame
120 min after ingestion
Title
iAUC insulin 500
Description
iAUC insulin 500
Time Frame
120 min after ingestion
Title
iAUC glucose 250
Description
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
Time Frame
120 min after ingestion
Title
iAUC insulin 250
Description
iAUC insulin 250
Time Frame
120 min after ingestion
Secondary Outcome Measure Information:
Title
diarrhea
Description
Occurrence of diarrhoea as assessed by stool frequency and Bristol Stool Forms Scale (Lewis, 1997) (3 or more loose or liquid stools per day, definition according to the WHO)
Time Frame
before and 60 and 120 minutes after ingestion with respect to the last 2 hours
Title
gastro-intestinal symptoms
Description
Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998)
Time Frame
before and 60 and 120 minutes after ingestion with respect to the last 2 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males aged ≥ 18y Impaired fasting glucose (IFG) Written informed consent Consent to collect stools and urine four times for three days Exclusion Criteria: Subjects currently enrolled in another clinical study Subjects having finished another clinical study within the last 4 weeks before inclusion. 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 No stools of type 5-7 of Bristol Stool Form Scale within the last week before inclusion 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. gluconic acid-containing OTCs, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Laue, Dr. (MD)
Organizational Affiliation
CRC Clinical Research Center Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC Clinical Research Center Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24118
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Glycemic Response to Two Doses of Low Sugar Apple Juice

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