N/A
Completed N=10
Physiological Effects of New Polyphenol-enriched Foods in Humans
Healthy
Source: ClinicalTrials.gov NCT01288859 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Serum Polyphenol Concentrations Over 24h From Food Consumption — 1.7; 12.1; 7.7; 0.01 nmol*h/L — p=0.02
Summary
Polyphenolic compounds exert several health benefits depending on bioavailability. Encapsulation may improve bioavailability of these compounds.This study will evaluate bioavailability of some polyphenols (curcumin and cocoa polyphenols) from new enriched-foods. In particular bread and nut based creams will be used as food matrices to include free or encapsulated polyphenols.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Polyphenol Concentrations Over 24h From Food Consumption |
1.7; 12.1; 7.7; 0.01; 7.3; 0.5 | 0.02 sig |
| PRIMARY Urinary Excretion of Total Polyphenols |
2.0; 2.21; 9.67; 19.1; 4.92; 1.31 | 0.01 sig |
| PRIMARY Amount of Total Fecal Polyphenols |
3.49; 0.49; 27.98; 4.27; 150.97; 0.59 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- 18 - 45 years old, male and female
- Healthy by medical assessment
- Normal weight: BMI 18 - 25
- Sign of a written informed consent
Exclusion Criteria
- Age > 18 and < 45 years old
- Pregnancy or breastfeeding
- Intestinal or metabolic diseases/disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer, including lactose-intolerance
- Previous abdominal/gastrointestinal surgery
- Regular consumption of medication
- Antibiotic therapy within 2 months previous the study
- Food allergies and intolerances (celiac disease, lactose intolerance, nut allergy etc)
- Unwilling to consume experimental foods
- Concurrent participation or having participated to another clinical trial during the last 3 weeks
Data sourced from ClinicalTrials.gov (NCT01288859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.