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

Efficacy study of a food supplement based on arabinoxylans obtained from barley on the reduction of postprandial glycemic response in healthy subjects: a monocentric, randomized, cross-over, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19301859
Enrollment
40
Registered
2022-03-22
Start date
2021-09-09
Completion date
Unknown
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial glycaemic responses Nutritional, Metabolic, Endocrine

Interventions

The subjects recruited in the present clinical study consume a bakery product (breadsticks) characterized by a high content of available carbohydrates (76.5% of available carbohydrates). In addition t

Sponsors

HEALLO s.r.l.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Italy

Contacts

Public ContactAlessandra Baldi
alessandra.baldi.alimenti@gmail.com+39 (0)3483854114

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026