NCT02145936

Brief Summary

The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 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

First Submitted

Initial submission to the registry

February 3, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

4.4 years

First QC Date

February 3, 2012

Last Update Submit

July 12, 2018

Conditions

Dyslipidemia

Keywords

fatty acid

Outcome Measures

Primary Outcomes (1)

  • inflammation

    interleukine (IL)-6, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, C-reactive protein (CRP), soluble forms of intercellular adhesion protein (slCAM)-1, vascular cell adhesion protein (sVCAM)-1, sE-selectin, sP-selectin and li0poprotein associated phospholipase A2 (LpPLA2).

    15-weeks

Secondary Outcomes (5)

  • lymphocyte proliferation and ex vivo cytokine secretion

    15 weeks

  • plasma lipids and lipoproteins

    15 weeks

  • desaturase activity

    15 weeks

  • insulin sensitivity

    15 weeks

  • coagulation biomarkers

    15 weeks

Study Arms (3)

oleic acid diet

EXPERIMENTAL

Participants are provided with meals enriched in oleic acid (18:1)

Other: diet

palmitic acid diet

EXPERIMENTAL

Participants are provided with meals enriched in palmitic acid (18:0)

Other: diet

stearic acid diet

EXPERIMENTAL

Participants are provided with meals enriched in stearic acid (18:0)

Other: diet

Interventions

dietOTHER

Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.

oleic acid dietpalmitic acid dietstearic acid diet

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Postmenopausal women (menopause defined by complete natural cessation of menses for \>12 months or a bilateral oophorectomy).
  • Age \>50 to \< 85 years
  • BMI \>20 to \<35 kg/m2
  • LDL-cholesterol \>100 mg/dL
  • CRP \<10 ug/dL
  • Normal fasting plasma glucose levels (\<120 mg/dL)
  • Not taking medication known to affect lipid metabolism:
  • HMG-CoA reductase inhibitors (statins)
  • Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
  • Cholesterol Absorption Inhibitors (Ezetimibe \[Zetia\])
  • Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
  • Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate \[Tricor\], etc)
  • Probucol
  • Anticoagulants (Coumadin, Heparin, Plavix, etc)
  • Hormone therapy medications containing estrogen
  • +53 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • Meng H, Matthan NR, Wu D, Li L, Rodriguez-Morato J, Cohen R, Galluccio JM, Dolnikowski GG, Lichtenstein AH. Comparison of diets enriched in stearic, oleic, and palmitic acids on inflammation, immune response, cardiometabolic risk factors, and fecal bile acid concentrations in mildly hypercholesterolemic postmenopausal women-randomized crossover trial. Am J Clin Nutr. 2019 Aug 1;110(2):305-315. doi: 10.1093/ajcn/nqz095.

    PMID: 31179489DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Diet

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Alice H Lichtenstein, D.Sc.

    Tufts University/HNRCA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2012

First Posted

May 23, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

July 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)