NCT02288585

Brief Summary

Double-blind, randomised, placebo-controlled, parallel group study with two intervention arms. The study will be conducted in 150 subjects and the primary objective is to show a fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

November 4, 2014

Last Update Submit

January 18, 2017

Conditions

Vascular DiseasesHypercholesterolemiaDiabetes Mellitus

Keywords

plant sterolsblood lipids

Outcome Measures

Primary Outcomes (2)

  • Change in TG concentrations

    At baseline (after 2 weeks run-in period) and after 6 weeks intervention

  • Change in LDL-C

    At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Secondary Outcomes (1)

  • Change in blood lipids

    At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Other Outcomes (4)

  • Change in blood glucose

    At baseline (after 2 weeks run-in period) and after 6 weeks intervention

  • Change in insulin

    At baseline (after 2 weeks run-in period) and after 6 weeks intervention

  • Acute, chronic and acute upon chronic effect on postprandial lipids, glucose and insulin

    At the end of intervention (after 6 weeks)

  • +1 more other outcomes

Study Arms (2)

Plant sterols

ACTIVE COMPARATOR

Plant sterols

Dietary Supplement: Plant sterols

Placebo product

PLACEBO COMPARATOR

Placebo product

Dietary Supplement: Placebo product

Interventions

Plant sterolsDIETARY_SUPPLEMENT

Plant sterols

Plant sterols
Placebo productDIETARY_SUPPLEMENT

Placebo product

Placebo product

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Triglycerides \>150 mg/dL or 1.74 mmol/L
  • LDL-cholesterol: Subjects at high risk for developing T2DM: 115-190 mg/dL or 2.95-4.94 mmol/L. Subjects with established T2DM that are on statins: 85-190 mg/dL or 2.15-4.94 mmol/L.
  • HbA1c: Subjects at high risk for developing T2DM: \<6.50% or ≥ 48 mmol/mol. Subjects with established T2DM: ≤ 8.5% or ≤ 69 mmol/mol.
  • BMI \> 20.0 kg/m2.

You may not qualify if:

  • Recently (within 1 year) diagnosed with cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions
  • Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. ezetimibe, fibrates and Niacin), to be judged by the principal investigator.
  • Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CSIRO

Adelaide, Australia

Location

CSIRO, North Ryde

Sydney, Australia

Location

Related Publications (1)

  • Trautwein EA, Koppenol WP, de Jong A, Hiemstra H, Vermeer MA, Noakes M, Luscombe-Marsh ND. Plant sterols lower LDL-cholesterol and triglycerides in dyslipidemic individuals with or at risk of developing type 2 diabetes; a randomized, double-blind, placebo-controlled study. Nutr Diabetes. 2018 May 25;8(1):30. doi: 10.1038/s41387-018-0039-8.

    PMID: 29795368DERIVED

MeSH Terms

Conditions

Vascular DiseasesHypercholesterolemiaDiabetes Mellitus

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Officials

  • Manny Noakes

    Commonwealth Scientific and Industrial Research Organisation, Australia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 11, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

AU(2)