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

Clinical Research Center Kiel

Status: Completed

Conditions: Prediabetes

Treatments: Other: 250 ml glucose-depleted apple juice; Other: 250 ml conventional apple juice; Other: 500 ml conventional apple juice; Other: 500 ml glucose-depleted apple juice

Study type: Interventional

Funder types: Other

Identifiers

NCT04747639

HB-RCT2-2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

32 participants in 4 patient groups, including a placebo group

verum 500

Active Comparator group

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.

Treatment:

Other: 500 ml glucose-depleted apple juice

control 500

Placebo Comparator group

Description:

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

Treatment:

Other: 500 ml conventional apple juice

verum 250

Active Comparator group

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.

Treatment:

Other: 250 ml glucose-depleted apple juice

control 250

Placebo Comparator group

Description:

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

Treatment:

Other: 250 ml conventional apple juice