NCT01629888

Brief Summary

The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable healthy

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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

June 26, 2012

Last Update Submit

October 7, 2016

Conditions

HealthyMild Hypercholesterolemia

Keywords

Plant sterolHypercholesterolemiadairy

Study Arms (2)

1 = Tested product

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

2 = Control product

PLACEBO COMPARATOR
Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Interventions

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

1 = Intervention 1 (3 test products/day)

1 = Tested product
2- plain low-fat dairy fermented product (drinkable) without plant sterols-estersOTHER

2 = Intervention 2 (3 control products/day)

2 = Control product

Eligibility Criteria

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

You may qualify if:

  • male/female subjects,
  • aged 20-65 years old,
  • triglycerides (TG) levels under 400 mg/dL,
  • total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
  • LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
  • non diabetic and non hypertensive,
  • accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
  • effective contraceptive methods used for female subjects,
  • having given written consent to take part in the study

You may not qualify if:

  • subjects with sitosterolemia,
  • subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
  • taking any hypocholesterolemic treatment,
  • presenting known allergy or hypersensitivity to plant sterols,
  • dairy products and lactose, subject with heavy alcohol intake (\> 60g/day),
  • receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
  • subjects receiving a transplant or under immunosuppressor treatment,
  • receiving treatment for any serious pathology.
  • for female subject:
  • pregnancy,
  • breast feeding or
  • intention to be pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Senri Chuo Ekimae Clinic

Osaka, 560-0082, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

June 1, 2010

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

JP(1)