Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Endocannabinoids
Brief summary
In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.
Interventions
DIETARY_SUPPLEMENTCLA enriched cheese
This study was a 3-week, randomized, single blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9.
Sponsors
Azienda Ospedaliera Brotzu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL), * 30-60 years of age
Exclusion criteria
* Pregnant (or those planning to become pregnant during the study period) and lactating women were excluded; * also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit. * In addition, those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening, were not enrolled. * Volunteers with the following characteristics were also excluded: * total cholesterol ≥ 300 mg/dL, * serum triglycerides ≥ 250 mg/dL or ≤ 200 mg/dL, * HDL ≥ 70mg/dL, * BMI ≥ 30, or * uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or * diastolic blood pressure ≥ 100 mm Hg) at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modification of LDL-cholesterol levels | baseline and 3 weeks |
Outcome results
None listed