NCT00000538

Brief Summary

To evaluate the effects of carefully controlled diets on lipoproteins and clotting factors in different demographic groups.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P25-P50 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Sep 1992

Shorter than P25 for phase_3 cardiovascular-diseases

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

September 1, 1992

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1995

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

February 22, 2024

Status Verified

August 1, 2014

Enrollment Period

2.7 years

First QC Date

October 27, 1999

Last Update Submit

February 20, 2024

Conditions

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with low HDL and/or high triglyceride levels and/or high insulin levels.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (12)

  • Ginsberg HN. New directions in dietary studies and heart disease: the National Heart, Lung and Blood Institute sponsored Multicenter Study of Diet Effects on Lipoproteins and Thrombogenic Activity. Adv Exp Med Biol. 1995;369:241-7. doi: 10.1007/978-1-4615-1957-7_23.

    PMID: 7598013BACKGROUND
  • Dennis BH, Stewart P, Wang CH, Champagne C, Windhauser M, Ershow A, Karmally W, Phillips K, Stewart K, Van Heel N, Farhat-Wood A, Kris-Etherton PM. Diet design for a multicenter controlled feeding trial: the DELTA program. Delta Research Group. J Am Diet Assoc. 1998 Jul;98(7):766-76. doi: 10.1016/s0002-8223(98)00173-4.

    PMID: 9664917BACKGROUND
  • Lefevre M, Ginsberg HN, Kris-Etherton PM, Elmer PJ, Stewart PW, Ershow A, Pearson TA, Roheim PS, Ramakrishnan R, Derr J, Gordon DJ, Reed R. ApoE genotype does not predict lipid response to changes in dietary saturated fatty acids in a heterogeneous normolipidemic population. The DELTA Research Group. Dietary Effects on Lipoproteins and Thrombogenic Activity. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):2914-23. doi: 10.1161/01.atv.17.11.2914.

    PMID: 9409276BACKGROUND
  • Reed RG, Kris-Etherton P, Stewart PW, Pearson TA. Variation of lipids and lipoproteins in premenopausal women compared with men and postmenopausal women. DELTA (Dietary Effects on Lipoproteins and Thrombogenic Activity) Investigators. Metabolism. 2000 Sep;49(9):1101-5. doi: 10.1053/meta.2000.8603.

    PMID: 11016887BACKGROUND
  • Ginsberg HN, Kris-Etherton P, Dennis B, Elmer PJ, Ershow A, Lefevre M, Pearson T, Roheim P, Ramakrishnan R, Reed R, Stewart K, Stewart P, Phillips K, Anderson N. Effects of reducing dietary saturated fatty acids on plasma lipids and lipoproteins in healthy subjects: the DELTA Study, protocol 1. Arterioscler Thromb Vasc Biol. 1998 Mar;18(3):441-9. doi: 10.1161/01.atv.18.3.441.

    PMID: 9514413BACKGROUND
  • Phillips KM, Tarrago-Trani MT, Grove TM, Grun I, Lugogo R, Harris RF, Stewart KK. Simplified gravimetric determination of total fat in food composites after chloroform-methanol extraction. Journal of American Oil Chemists' Society 74(2): 137-142, 1997.

    BACKGROUND
  • Mustad VA, Etherton TD, Cooper AD, Mastro AM, Pearson TA, Jonnalagadda SS, Kris-Etherton PM. Reducing saturated fat intake is associated with increased levels of LDL receptors on mononuclear cells in healthy men and women. J Lipid Res. 1997 Mar;38(3):459-68.

    PMID: 9101427BACKGROUND
  • Phillips KM, Tarrago-Trani MT, Stewart KK. Phytosterol content of experimental diets differing in fatty acid composition. Food Chemistry 64(3): 415-422, 1999. https://www.sciencedirect.com/science/article/pii/S0308814698000909

    BACKGROUND
  • Berglund L, Oliver EH, Fontanez N, Holleran S, Matthews K, Roheim PS, Ginsberg HN, Ramakrishnan R, Lefevre M. HDL-subpopulation patterns in response to reductions in dietary total and saturated fat intakes in healthy subjects. Am J Clin Nutr. 1999 Dec;70(6):992-1000. doi: 10.1093/ajcn/70.6.992.

    PMID: 10584043BACKGROUND
  • Kris-Etherton PM, Pearson TA, Wan Y, Hargrove RL, Moriarty K, Fishell V, Etherton TD. High-monounsaturated fatty acid diets lower both plasma cholesterol and triacylglycerol concentrations. Am J Clin Nutr. 1999 Dec;70(6):1009-15. doi: 10.1093/ajcn/70.6.1009.

    PMID: 10584045BACKGROUND
  • Aussel C, Fehlmann M. Effect of alpha-fetoprotein on arachidonic acid metabolism in a human T-cell line. Immunol Lett. 1987 Jan;14(2):133-7. doi: 10.1016/0165-2478(87)90092-7.

    PMID: 2438210BACKGROUND
  • Kris-Etherton PM, Stewart PW, Ginsberg HN, Tracy RP, Lefevre M, Elmer PJ, Berglund L, Ershow AG, Pearson TA, Ramakrishnan R, Holleran SF, Dennis BH, Champagne CM, Karmally W; DELTA Investigators. The Type and Amount of Dietary Fat Affect Plasma Factor VIIc, Fibrinogen, and PAI-1 in Healthy Individuals and Individuals at High Cardiovascular Disease Risk: 2 Randomized Controlled Trials. J Nutr. 2020 Aug 1;150(8):2089-2100. doi: 10.1093/jn/nxaa137.

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesHyperlipoproteinemiasMyocardial IschemiaThrombosis

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Vascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Patricia Elmer

    University of Minnesota

  • Penny Kris-Etherton

    Penn State University

  • Paul Roheim

    Louisiana State University Medical Center

  • Henry Ginsberg

    Columbia University

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1992

Primary Completion

May 1, 1995

Study Completion

May 1, 1995

Last Updated

February 22, 2024

Record last verified: 2014-08