Glycemic Response to Two Doses of Low Sugar Apple Juice

Prediabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747639
• Other study ID #: HB-RCT2-2015
• Status: Completed
• Phase: N/A
• Start date: October 28, 2015
• Est. completion date: February 2021

Study information

• Verified date: February 2021
• Source: Clinical Research Center Kiel GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2021
• Est. primary completion date: May 9, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prediabetes
• Prediabetic State

Intervention

Other:
• 500 ml glucose-depleted apple juice

• 500 ml conventional apple juice

• 250 ml glucose-depleted apple juice

• 250 ml conventional apple juice

Locations

Country	Name	City	State
Germany	CRC Clinical Research Center Kiel	Kiel	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Center Kiel GmbH	Nofima

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iAUC glucose 500	Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice	120 min after ingestion
Primary	iAUC insulin 500	iAUC insulin 500	120 min after ingestion
Primary	iAUC glucose 250	Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice	120 min after ingestion
Primary	iAUC insulin 250	iAUC insulin 250	120 min after ingestion
Secondary	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
Secondary	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