Healthy subjects
Conditions
Interventions
Group 1: Saskatoon berry extract, 1100 mg p.o. supplemented as 3 capsules containing 365 mg each (1 capsule in the morning, 1 at noon, 1 in the evening)
supplementation for 12 weeks
Group 2: Placebo (maltodextrin) p.o. 3 capsules per day (1 capsule in the morning, 1 capsule at noon, 1 capsule in the evening)
supplementation for 12 weeks
Sponsors
Prairie Berries Europe GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age: 18-75 years BMI: 18.5-35 kg/m² Adults at total CV risk score 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum LDL-cholesterol (Blood sampling: baseline = visit 1, after 6 weeks= V2, after 12 weeks = V3; Friedewald formula | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum total cholesterol, HDL-cholesterol, triglycerides (Baseline, V2, V3); fasting; photometric determination Optional: hsCRP (Baseline, V3), laser nephelometry Optional: ox LDL (Baseline, V3), ELISA | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
Biotesys GmbH
Outcome results
None listed