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

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

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

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Other: 500 ml glucose-depleted apple juice; Other: 500 ml conventional apple juice; Other: 250 ml glucose-depleted apple juice; Other: 250 ml conventional apple juice

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24118
      • CRC Clinical Research Center Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: verum 500; 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
Placebo Comparator: control 500; 500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)	Other: 500 ml conventional apple juice
Active Comparator: verum 250; 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
Placebo Comparator: control 250; 250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)	Other: 250 ml conventional apple juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	before and 60 and 120 minutes after ingestion with respect to the last 2 hours
gastro-intestinal symptoms	Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998)	before and 60 and 120 minutes after ingestion with respect to the last 2 hours

Collaborators and Investigators

• Sponsor: Clinical Research Center Kiel GmbH
• Collaborators: Nofima
• Investigators: Principal Investigator: Christiane Laue, Dr. (MD), CRC Clinical Research Center Kiel

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2015
• Primary Completion (Actual): May 9, 2016
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: glycemic response, enzymatic conversion, gluconate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: HB-RCT2-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No