Overweight/obesity Nutritional, Metabolic, Endocrine Overweight/obesity
Conditions
Interventions
Participants are randomly allocated into two groups - group A and group B.
Participants will be followed by a 2-arm parallel-group design including 4-week run-in periods and 8-week tre
Sponsors
Samnium Medical Cooperative (Benevento, Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-83 years of age 2. Of white race 3. Overweight/obese (BMI >25 kg/m²).
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Unless otherwise stated, the following are assessed at weeks 0, 4, 8, 12 and 16: 1. Clinical history, assessed by interviews and analysis of previous clinical data at the baseline 2. Anthropometric measures, collected by measuring height and weight 3. Nutrient intake and dietary habits, assessed using a seven day food record validated nutritional questionnaire at the baseline and at the end of the study period 4. Blood pressure, assessed using a blood pressure cuff 5. Plasma total cholesterol (TC), measured from blood samples using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 6. HDL-C, measured from blood samples using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 7. LDL-C, measured from blood samples using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 8. Triglyceride levels, measured from blood samples using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 9. Plasma glycaemia, measured from blood samples using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 10. Plasma insulin, measured from blood samples using ELISA 11. ox-LDL, measured from blood samples using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 12. Blood analysis of the following, measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially | — |
Countries
Italy
Contacts
Public ContactGian Carlo;Giuseppe Tenore;Annunziata
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Outcome results
None listed