Glycemic Response to Two Doses of Low Sugar Apple Juice

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Other: 500 ml glucose-depleted apple juice; Other: 500 ml conventional apple juice; Other: 250 ml conventional apple juice; Other: 250 ml glucose-depleted apple juice

• Registration Number: NCT04747639
• Lead Sponsor: Clinical Research Center Kiel GmbH

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.

Study Timeline

• Study Start: 2015-10-28
• Primary Completion: 2016-05-09
• Status Verified: 2021-02
• Study Completion: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
verum 500	500 ml glucose-depleted apple juice	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.
control 500	500 ml conventional apple juice	500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
control 250	250 ml conventional apple juice	250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
verum 250	250 ml glucose-depleted apple juice	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.

Primary Outcome Measures

Name	Time	Method
iAUC glucose 500	120 min after ingestion	Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
iAUC glucose 250	120 min after ingestion	Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
iAUC insulin 500	120 min after ingestion	iAUC insulin 500
iAUC insulin 250	120 min after ingestion	iAUC insulin 250

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CRC Clinical Research Center Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany