NCT00430430

Brief Summary

Low and very low carbohydrate diets, such as the Atkins' Diet, have recently gained attention for their potential health benefits from weight loss and have gained some scientific support from a growing number of studies. Benefits have been noted in relation to raised "good" cholesterol, lower "bad" cholesterol and triglycerides. Other studies have shown an advantage in substituting vegetable fat for carbohydrate in insulin resistant individuals and in some instances in type 2 diabetes where improvements were seen in "good" cholesterol and blood sugars. At the same time, our research have been exploring diets containing less processed carbohydrates and other components which in combination (portfolio diet) have a similar cholesterol lowering effect to drug therapy. Therefore we wish to determine whether our cholesterol-lowering components (portfolio diet) should be incorporated into lower carbohydrate diets especially to preserve "good" cholesterol and lower "bad" cholesterol for decreasing the risk of heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2007

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

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

January 30, 2007

Last Update Submit

October 25, 2016

Conditions

HyperlipidemiaCardiovascular DiseasesDiet Therapy

Outcome Measures

Primary Outcomes (1)

  • HDL-C and VLDL-TG, synthesis and fractional catabolic rates of their respective apolipoproteins, apo AI and B100

    2 months

Secondary Outcomes (1)

  • LDL-C, LDL particle size, total and VLDL triglyceride, C-reactive protein, intravascular enzymes, HDL subfractions, blood glucose and insulin (HOMA models S and B), and relation of listed outcomes to kinetic parameters

    2 months

Study Arms (2)

High MUFA

EXPERIMENTAL

high monounsaturated fat background diet to portfolio diet

Procedure: High MUFA dietary portfolio

Low MUFA

ACTIVE COMPARATOR

low monounsaturated fat background diet to portfolio diet

Procedure: Low MUFA dietary portfolio

Interventions

High MUFA dietary portfolioPROCEDURE

high monounsaturated fat background diet to dietary portfolio

High MUFA
Low MUFA dietary portfolioPROCEDURE

low monounsaturated fat background diet to dietary portfolio

Low MUFA

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and postmenopausal women
  • Body mass index \> 18.5 kg/m2 and \< 40 kg/m2
  • Fasting plasma triglyceride (TG) concentration \> 2.5 mmol/l and \< 6.0 mmol/l at recruitment.
  • Fasting plasma LDL cholesterol concentration \> 3.4 mmol/l at recruitment.
  • Fasting plasma HDL cholesterol concentration \< 1.0 mmol/l at recruitment.
  • living within a 40 km radius of St. Michael's Hospital.

You may not qualify if:

  • Premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle and the difficulty of synchronising the timing of three one month studies with the same point in the menstrual cycle.
  • Taking cholesterol medications at the start of the study. However, with their physician's approval those who wish to join but are already taking cholesterol-lowering medications (or cholesterol lowering natural health products) may join the study providing the medications (or natural health products) are stopped for at least 2 weeks before starting the study and throughout the study.
  • Patients with uncontrolled high blood pressure will be excluded. The cut off for raised blood pressure has been taken as greater than 140/90mmHg. Patients with systolic blood pressure between 140-150mmHg and diastolic blood pressure between 90-95mmHg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. For patients in the above normal range (as above), a letter will be required from the physician responsible for their care.
  • Changing the type or dose of their drug treatment during the study.
  • Those judged as having a likelihood of being non-compliant with instructions for whatever reason. Those with low compliance to lipid-lowering therapy will not be selected.
  • Food allergies
  • Evidence or history of diabetes, renal liver disease or gastrointestinal disease. Patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyperabsorbers of plant sterols.
  • Patients with major cardiovascular event (stroke or myocardial infarction), with secondary causes of hypercholesterolemia (or untreated hypothyroidism), with uncontrolled blood pressure, major disability or disorder such as liver disease, renal failure or with major surgery \< 6 months prior to randomization. Individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will also be excluded.
  • Antibiotic use within the last three months.
  • Hormone replacement therapy.
  • Smokers or have significant alcohol intake (\>1 drink/d).
  • Disallowed medications will be cholesterol lowering drugs which if prescribed by patients' physicians while on the study will be a reason for discontinuation from the study. Introduction of cholesterol lowering natural health products during the study will also be a reason for withdrawing a participant from the study.
  • individuals with acute (\<6 weeks) or chronic (\>6 weeks) infections, either bacterial or viral, or individuals suffering from chronic inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

  • Jenkins DJ, Chiavaroli L, Wong JM, Kendall C, Lewis GF, Vidgen E, Connelly PW, Leiter LA, Josse RG, Lamarche B. Adding monounsaturated fatty acids to a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. CMAJ. 2010 Dec 14;182(18):1961-7. doi: 10.1503/cmaj.092128. Epub 2010 Nov 1.

    PMID: 21041432DERIVED

MeSH Terms

Conditions

HyperlipidemiasCardiovascular Diseases

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David JA Jenkins, MD, PhD, DSc

    University of Toronto and St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

CA(1)