NCT01825668

Brief Summary

The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as infants as a function of the duration of breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile favorably in the study population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 3, 2016

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

March 21, 2013

Last Update Submit

February 2, 2016

Conditions

HypercholesterolemiaCVD

Outcome Measures

Primary Outcomes (1)

  • Change in LDL-cholesterol

    Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month

Secondary Outcomes (2)

  • Change in Cholesterol Absorption

    Day 26-30 of each of the 3 phases. Each phase duration is 1 month

  • Change in Cholesterol Synthesis

    Day 26-30 of each of the 3 phases. Each phase duration is 1 month

Study Arms (3)

High cholesterol

EXPERIMENTAL

600 mg cholesterol/day in 240 ml milk shake

Other: High cholesterol

Plant sterols

EXPERIMENTAL

2.0 g of plant sterols/day in 240 ml milk shake containing 50 mg cholesterol

Other: Plant Sterols

Placebo

PLACEBO COMPARATOR

50 mg cholesterol/day in 240 ml of milk shake

Other: Placebo

Interventions

Plant SterolsOTHER
Plant sterols
High cholesterolOTHER
High cholesterol
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Triglycerides (TG) \<3.0 mmol/L
  • Body mass index (BMI) between 20 and 30 kg/m2
  • Participants must have been breast-fed at least during the first 6 months of their life

You may not qualify if:

  • History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
  • History of chronic use of alcohol (\>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
  • Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
  • Sitosterolemic patients
  • Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
  • Exercise greater than walking or running 15 miles/wk or 4,000 kcal/wk
  • Participants who have not been breast-fed at all
  • Pregnant or planning for pregnancy during the next 5 month period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

PhytosterolsCholesterol, HDL

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological FactorsCholesterolLipoproteins, HDLLipoproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Peter JH Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 21, 2013

First Posted

April 8, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

June 1, 2016

Last Updated

February 3, 2016

Record last verified: 2013-03

Locations

CA(1)