Beneficial effect of innovative nutraceutical formulation based on grape pomace polyphenolic extract on serum levels of TMAO, a new biomarker of cardiovascular diseases

Not Applicable

Completed

• Conditions: Overweight/obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN10794277
• Lead Sponsor: Samnium Medical Cooperative (Benevento, Italy)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31164827 results (added 06/06/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34350218/ (added 06/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Study Completion: 2019-01-28
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Aged 18-83 years of age
2. Of white race
3. Overweight/obese (BMI >25 kg/m²).

Exclusion Criteria

1. Smokers
2. Hepatic disease
3. Renal disease
4. Heart disease
5. Family history of chronic diseases
6. Drug therapy or supplement intake containing grape polyphenols
7. Heavy physical exercise (over 10 hours per week)
8. Pregnant, suspected of being pregnant or hoping to become pregnant
9. Breastfeeding
10. Birch pollen allergy
11. Use of vitamin or mineral supplements 2 weeks prior to entry into the study
12. 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
Trimethylamine N-oxide (TMAO) serum levels, assessed using liquid chromatography/mass spectrometry (LC/MS) analysis of blood samples at weeks 1, 5 and 12 of the study period.