Glycemic Response to Two Doses of Low Sugar Apple Juice

NCT ID: NCT04747639

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-28
• Study Completion Date: 2021-02-28

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.

Conditions

Prediabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

500 ml glucose-depleted apple juice

Intervention Type: OTHER

control 500

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

Group Type: PLACEBO_COMPARATOR

500 ml conventional apple juice

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

250 ml glucose-depleted apple juice

Intervention Type: OTHER

control 250

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

Group Type: PLACEBO_COMPARATOR

250 ml conventional apple juice

Intervention Type: OTHER

Interventions

500 ml glucose-depleted apple juice

Intervention Type: OTHER

500 ml conventional apple juice

Intervention Type: OTHER

250 ml glucose-depleted apple juice

Intervention Type: OTHER

250 ml conventional apple juice

Intervention Type: OTHER

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Nofima

OTHER

Sponsor Role: collaborator

Clinical Research Center Kiel GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christiane Laue, Dr. (MD)

Role: PRINCIPAL_INVESTIGATOR

CRC Clinical Research Center Kiel

Locations

CRC Clinical Research Center Kiel

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

HB-RCT2-2015

Identifier Type: -

Identifier Source: org_study_id