Long-term Effectiveness Study on Cholesterol-reducing Activity

Danone

Status: Completed

Conditions: Normal and Mild Hypercholesterolemic Subjects

Treatments: Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).; Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).; Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521169

NU332

Details and patient eligibility

About

The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.

Enrollment: 138 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
2. Subject aged from 20 to 65 years (bounds included)
3. Subject with BMI between 19 - 30 kg/m² (bounds included)
4. Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
5. Non diabetic subjects (BS≤125 mg/dL)
6. Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg)
7. Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
8. Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
9. Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study

Exclusion criteria

1. Subject currently involved in a clinical trial.
2. Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
3. Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study.
4. For female subject: pregnancy or intention to be pregnant during the study.
5. For female subject: breast feeding.
6. Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
7. Subject having lactose intolerance.
8. Subjects having sitosterolemia
9. Diabetic subject (Type I and type II)
10. Subject with heavy alcohol intake (>60g/day)
11. Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
12. Subject receiving a transplant or under immunosuppressor treatment
13. Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
14. Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
15. Subject deemed unsuitable by the investigator.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 3 patient groups

1 = Tested product dose 1

Active Comparator group

Treatment:

Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).

2 = Tested product dose 2

Active Comparator group

Treatment:

Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).

3 = Control product

Sham Comparator group

Treatment:

Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols.