Clinical study to investigate lipid-modifying effects of a Saskatoon berry extract - a randomized, double-blind, placebo-controlled parallel study
- Conditions
- Healthy subjects
- Registration Number
- DRKS00015503
- Lead Sponsor
- Prairie Berries Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Age: 18-75 years
BMI: 18.5-35 kg/m²
Adults at total CV risk score <1 % (low risk (SCORE-Germany)) and LDL-C levels >160 and <190 mg/dL
Or
Adults at total CV risk score =1 % and <5 % (moderate risk (SCORE-Germany)) and LDL-C levels =115 and <190 mg/dL
Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Medication to lower serum lipids
Serum fasting TG > 500 mg/dL
History of cardiovascular disease
Chronic diseases (e.g. diabetes, cancer, liver disease etc)
Consumption of any dietary supplement /fortified food known to influence cholesterol levels
Weight loss intervention or recent boy weight change >4.5 kg
Diet high in vegetables and fruits = 5 portions per day
Vegan lifestyle
Smoker > 10 cigarettes / day
Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s disease, peptic ulcers, celiac disease)
Drug-, alcohol- and medication abuses
Known HIV-infection
Known acute or chronic hepatitis B and C infection
Relevant allergy or known hypersensitivity against compounds of the study preparations
Women: known pregnancy, breast feeding or intention to become pregnant during the study
Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
Blood donation within 4 weeks prior study start (screening) or during study.
Anticipating any planned changes in lifestyle for the duration of the study
Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum LDL-cholesterol (Blood sampling: baseline = visit 1, after 6 weeks= V2, after 12 weeks = V3; Friedewald formula
- Secondary Outcome Measures
Name Time Method Serum total cholesterol, HDL-cholesterol, triglycerides (Baseline, V2, V3); fasting; photometric determination<br>Optional: hsCRP (Baseline, V3), laser nephelometry<br>Optional: ox LDL (Baseline, V3), ELISA