NCT01716390

Brief Summary

To determine the effect of investigational products on serum LDL cholesterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

October 25, 2012

Last Update Submit

October 6, 2020

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Change in serum LDL cholesterol

    0 vs 4 weeks

Study Arms (2)

Drink that contains plant stanols

ACTIVE COMPARATOR

Dietary supplement: Plant stanol

Dietary Supplement: Drink that contains plant stanols

Placebo drink

PLACEBO COMPARATOR

Dietary supplement: Placebo

Dietary Supplement: Placebo drink

Interventions

Drink that contains plant stanolsDIETARY_SUPPLEMENT
Drink that contains plant stanols
Placebo drinkDIETARY_SUPPLEMENT
Placebo drink

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults
  • signed written informed consent

You may not qualify if:

  • participation in a clinical study within 30 days prior to screening visit and throughout the study
  • severe obesity
  • consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study
  • consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Food Practice

Uppsala, Sweden

Location

Related Publications (1)

  • Hallikainen M, Olsson J, Gylling H. Low-Fat Nondairy Minidrink Containing Plant Stanol Ester Effectively Reduces LDL Cholesterol in Subjects with Mild to Moderate Hypercholesterolemia as Part of a Western Diet. Cholesterol. 2013;2013:192325. doi: 10.1155/2013/192325. Epub 2013 Sep 16.

    PMID: 24151550DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Johan Olsson, PhD

    Good Food Practice, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

SE(1)