NCT01521169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

January 26, 2012

Last Update Submit

October 26, 2016

Conditions

Normal and Mild Hypercholesterolemic Subjects

Keywords

Plant sterol - Hypercholesterolemia - Diet - Dairy

Study Arms (3)

1 = Tested product dose 1

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

3 = Control product

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

Interventions

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

1 = Intervention with test product 1 (0,8g of plant sterol/day)

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

2 = Intervention with test product 2 (1,6g of plant sterol/day)

2 = Tested product dose 2
3 - low-fat dairy fermented product (drinkable) without plant sterols.OTHER

3 = Intervention 3 (1 control product/day)

3 = Control product

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Subject aged from 20 to 65 years (bounds included)
  • Subject with BMI between 19 - 30 kg/m² (bounds included)
  • Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
  • Non diabetic subjects (BS≤125 mg/dL)
  • Non hypertensive subjects (SBP\<140mmHg and DBP\<90 mmHg)
  • Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
  • Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
  • 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

You may not qualify if:

  • Subject currently involved in a clinical trial.
  • Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
  • 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.
  • For female subject: pregnancy or intention to be pregnant during the study.
  • For female subject: breast feeding.
  • Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
  • Subject having lactose intolerance.
  • Subjects having sitosterolemia
  • Diabetic subject (Type I and type II)
  • Subject with heavy alcohol intake (\>60g/day)
  • Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
  • Subject receiving a transplant or under immunosuppressor treatment
  • Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
  • 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
  • Subject deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Senrichuo Ekimae Clinic - Senri Life Science Center 13F

Osaka, 560-0082, Japan

Location

MeSH Terms

Interventions

Phytosterols

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 30, 2012

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

JP(1)