Beneficial potential of a nutraceutical formulation containing abscisic acid in patients with type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN16732651
• Lead Sponsor: Samnium Medical Cooperative (Benevento, Italy)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36076823/ (added 05/12/2022) 2023 Results article in https://doi.org/10.3390/foods12051077 (added 06/08/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-16
• Study Start: 2022-07-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Patients aged 18–83 years.
2. Clinical diagnosis of type 2 diabetes mellitus (T2DM) according to American Diabetes Association (ADA).

Exclusion Criteria

1. Smokers
2. Hepatic disease
3. Renal disease
4. Heart disease
5. Type 1 diabetes mellitus (T1DM)
6. Family history of chronic diseases
7. Drug therapy or supplement intake containing polyphenols
8. Heavy physical exercise (over 10 hours per week)
9. Underweight (Body Mass Index <18.5 kg/m²)
10. Pregnant, suspected of being pregnant or hoping to become pregnant
11. Breastfeeding
12. Birch pollen allergy
13. Use of vitamin or mineral supplements 2 weeks prior to entry into the study
14. Donation of blood less than 3 months prior to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For the evaluation of the primary outcomes, blood samples were collected after 12 h of fasting at 0 and 12 weeks in 10-mL EDTA coated tubes, and plasma was immediately isolated by centrifugation (20 min, 2.200 g, 4°C). All samples were stored at -80°C until analysis.<br>1. Fasting plasma glucose (FPG), determined using commercially available kits (Diacron International, Italy).<br>2. Glycated hemoglobin (HbA1c), determined with a commercially available kit (InterMedical s.r.l, Italy). <br>3. Fasting plasma insulin (FPI), measured using an enzyme-linked immunosorbent (ELISA) assay commercial kit (InterMedical s.r.l, Italy). <br>4. Homeostatic model assessment of insulin resistance (HOMA index), calculated with the formula: FPG (mg/dl) times FPI (µUI/ml) divided by 22.5. <br>5. Abscisic acid (ABA) plasma levels, assessed using liquid chromatography/mass spectrometry (LC/MS) analysis of blood samples.