Effect of Cocoa Consumption in Cardiovascular and Immune Parameters
Paraules clau
Resum
Dates
| Darrera verificació: | 11/30/2011 |
| Primer enviat: | 11/23/2011 |
| Inscripció estimada enviada: | 12/15/2011 |
| Publicat per primera vegada: | 12/20/2011 |
| Última actualització enviada: | 12/15/2011 |
| Publicació de l'última actualització: | 12/20/2011 |
| Data d'inici de l'estudi real: | 06/30/2009 |
| Data estimada de finalització primària: | 06/30/2011 |
| Data estimada de finalització de l’estudi: | 06/30/2011 |
Condició o malaltia
Intervenció / tractament
Dietary Supplement: Dark chocolate
Dietary Supplement: White chocolate
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Active Comparator: Dark chocolate Presence of 70% cocoa solids | Dietary Supplement: Dark chocolate Each chocolate bar provided 210 calories represented in 25 grams of carbohydrates, 3 g of proteins, 18 g of total fat and the presence of 70% cocoa solids |
| Placebo Comparator: White chocolate | Dietary Supplement: White chocolate Each chocolate bar provided 230 calories represented in 28 grams of carbohydrates, 3 g of proteins, 18 g of total fat, without the presence of 70% cocoa solids |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - Age: 18 - 65 years old - Resides in Medellín City - Attached from the contributive regimen of Colombian Health System - Essential Arterial Hypertension, stage I. Diagnosis less than 3 months. - Medically indicated non-pharmacological therapy. - Voluntary desire to consume 50 grams of chocolate per day for 12 weeks. - Voluntary desire to participate in the trial and sign informed consent. Exclusion Criteria: - Suspect of secondary hypertension - Suspect of injury in target organ - Presence of diabetes mellitus - BMI (Body Mass Index) major or equal to 30 - Present smoker or with less than four weeks of abstinence of tobacco - Consume antiplatelet substances - Regular consumption of antioxidants, multivitamins, anti-inflammatory medications, drugs for nasal congestion and sibutramine |
Resultat
Mesures de resultats primaris
1. Change in diastolic blood pressure [Baseline and 12 weeks]
Mesures de resultats secundaris
1. Change in systolic blood pressure [Baseline and 12 weeks]
2. Change in total cholesterol [Baseline and 12 weeks]
3. Change in low density lipoprotein cholesterol [Baseline and 12 weeks]
4. Change in high density lipoprotein cholesterol [Baseline and 12 weeks]
5. Change in triglycerides levels [Baseline and 12 weeks]
6. Change in hs-CRP [Baseline and 12 weeks]
7. Change in IL-1 beta levels [Baseline and 12 weeks]
8. Change in IL-2 levels [Baseline and 12 weeks]
9. Change in tumor necrosis factor alpha levels [Baseline and 12 weeks]
10. Change in flow mediated dilatation of the brachial artery [Baseline and 12 weeks]
