The beneficial effect of a food supplement based on arabinoxylans obtained from barley on blood sugar levels after eating

Not Applicable

Completed

• Conditions: Postprandial glycaemic responses; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN19301859
• Lead Sponsor: HEALLO s.r.l.

Brief Summary

2022 Results article in https://doi.org/10.3390/nu14193916 (added 18/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-05
• Study Start: 2022-03-22
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Healthy subjects, according to what was determined by the clinical history and by the information provided during the recruitment
2. Aged between 18 and 65 years
3. Non-smokers
4. Subjects able to understand and to sign the Informed Consent

Exclusion Criteria

1. Subjects with type 1 or 2 diabetes
2. Subjects with fasting blood glucose >110 mg/dl
3. Subjects with blood pressure values >160/100 mmHg
4. Subjects with metabolic disorders
5. Subjects with endocrine, cardiovascular, pulmonary, renal or gastrointestinal diseases, which may interfere with the results of the study
6. Subjects with sensitivity, intolerance or allergy to products used in the clinical trial
7. Pregnant or lactating women
8. Subjects who have donated blood in the 3 months prior to recruitment
9. Subjects under pharmacological treatment, with drugs that could interfere with the study, such as alpha-glucosidase inhibitors (acarbose etc), insulin-sensitive drugs (metformin etc), sulfanilureee, cholesterol medications, and any other medications that the physician does not deem compatible with the study
10.Subjects who were taking food supplements that could interfere with the study, such as products high in vitamins and minerals (>200% VNR), B vitamins, C vitamin, calcium, zinc, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, essential fatty acid products, botanicals, and any other products that the physician does not deem compatible with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial blood glucose evaluated using blood tests following blood sampling at t0 (on an empty stomach and at 15, 30, 60, 90, and 120 minutes after intake of the treatment and breadsticks) and after 5 days of the wash-out period (in which subjects took no treatment), prior to cross-over of treatments (at the times indicated for t0)

Secondary Outcome Measures

Name	Time	Method
Postprandial insulinemic response evaluated using blood tests following blood sampling at t0 (on an empty stomach and at 15, 30, 60, 90, and 120 minutes after intake of the treatment and breadsticks) and after 5 days of the wash-out period (in which subjects take no treatment), prior to cross-over of treatments (at the times indicated for t0)