NCT02628990

Brief Summary

The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

Trial Health

100
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Shorter than P25 for not_applicable

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

June 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

December 1, 2015

Last Update Submit

December 9, 2015

Conditions

HypercholesterolemiaHyperlipidemiasDyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Percentual change in serum LDL-cholesterol

    Percentual change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups

    4 weeks

  • Absolute change in serum LDL-cholesterol

    Absolute change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups, mmol/l

    4 weeks

Secondary Outcomes (6)

  • Percentual change in serum total cholesterol

    4 weeks

  • Absolute change in serum total cholesterol

    4 weeks

  • Percentual change in serum non-HDL cholesterol

    4 weeks

  • Absolute change in serum non-HDL cholesterol

    4 weeks

  • Percentual change in serum triglycerides

    4 weeks

  • +1 more secondary outcomes

Study Arms (5)

1.6 g plant stanols

EXPERIMENTAL

A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks

Other: 1.6 g plant stanols

2 g plant stanols

EXPERIMENTAL

A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks

Other: 2 g plant stanols

1.6 g plant stanols and camelina oil

EXPERIMENTAL

A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Other: 1.6 g plant stanols and camelina oil

2 g plant stanols and camelina oil

EXPERIMENTAL

A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Other: 2 g plant stanols and camelina oil

Placebo

PLACEBO COMPARATOR

A placebo yoghurt drink, consumed with a meal daily for 4 weeks

Other: Placebo

Interventions

1.6 g plant stanolsOTHER

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols

1.6 g plant stanols
2 g plant stanolsOTHER

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols

2 g plant stanols
1.6 g plant stanols and camelina oilOTHER

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil

1.6 g plant stanols and camelina oil
2 g plant stanols and camelina oilOTHER

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil

2 g plant stanols and camelina oil
PlaceboOTHER

Lipid-lowering effect of Placebo Yoghurt Drink

Placebo

Eligibility Criteria

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

You may qualify if:

  • BMI \< 30 kg/m2
  • moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
  • serum triglycerides \< 3 mmol/l.
  • normal liver, kidney and thyroid function
  • subjects must voluntarily sign the informed consent

You may not qualify if:

  • use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
  • lipid lowering medication
  • history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
  • pregnancy or lactation
  • alcohol abuse
  • subjects with intolerance to any ingredient of the test products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Salo P, Kuusisto P. Cholesterol Lowering Effect of Plant Stanol Ester Yoghurt Drinks with Added Camelina Oil. Cholesterol. 2016;2016:5349389. doi: 10.1155/2016/5349389. Epub 2016 Feb 21.

    PMID: 26998355DERIVED

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemiasDyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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

December 1, 2015

First Posted

December 11, 2015

Study Start

June 1, 2005

Primary Completion

August 1, 2005

Study Completion

November 1, 2005

Last Updated

December 11, 2015

Record last verified: 2015-12