NCT00051350

Brief Summary

To compare the effects on blood pressure and plasma lipids of three different diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable 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

May 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2003

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

5.8 years

First QC Date

January 9, 2003

Last Update Submit

October 2, 2018

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisHypertension

Study Arms (3)

CARB

PLACEBO COMPARATOR

Diet rich in carbohydrate

Other: CARB

UNSAT

ACTIVE COMPARATOR

Diet rich in unsaturated fat

Other: CARB

PROTEIN

ACTIVE COMPARATOR

Diet rich in protein

Other: CARB

Interventions

CARBOTHER
Also known as: UNSAT, PROTEIN
CARBPROTEINUNSAT

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults
  • Aged 30 years and older
  • Systolic blood pressure of 120 to 159 mm Hg or a diastolic blood pressure of 80 to 99 mm Hg.

You may not qualify if:

  • Diabetes
  • Active or prior Cardiovascular disease (CVD)
  • LDL cholesterol greater than 220 mg/dL (\>5.70 mmol/L)
  • Fasting triglycerides greater than 750 mg/dL (\>8.48 mmol/L)
  • Weight more than 350 lb (\>159 kg)
  • Taking medications that affect blood pressure or blood lipid levels
  • Unwillingness to stop taking vitamin and mineral supplements
  • Alcoholic beverage intake of more than 14 drinks per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Appel LJ, Sacks FM, Carey VJ, Obarzanek E, Swain JF, Miller ER 3rd, Conlin PR, Erlinger TP, Rosner BA, Laranjo NM, Charleston J, McCarron P, Bishop LM; OmniHeart Collaborative Research Group. Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial. JAMA. 2005 Nov 16;294(19):2455-64. doi: 10.1001/jama.294.19.2455.

    PMID: 16287956BACKGROUND

  • Zhang B, Furtado JD, Andraski AB, Guglielmo B, Appel LJ, Wang K, Yasunaga S, Saku K, Ikewaki K, Sacks FM. Partially Replacing Dietary Carbohydrate With Unsaturated Fat or Protein Shifts Protein-Based HDL Subspecies Toward Lower Coronary Heart Disease Risk. Arterioscler Thromb Vasc Biol. 2026 Jan;46(1):251-267. doi: 10.1161/ATVBAHA.125.323709. Epub 2025 Dec 2.

    PMID: 41328959DERIVED

  • Kim H, Lichtenstein AH, Ganz P, Miller ER 3rd, Coresh J, Appel LJ, Rebholz CM. Associations of circulating proteins with lipoprotein profiles: proteomic analyses from the OmniHeart randomized trial and the Atherosclerosis Risk in Communities (ARIC) Study. Clin Proteomics. 2023 Jul 3;20(1):27. doi: 10.1186/s12014-023-09416-x.

    PMID: 37400771DERIVED

  • Belanger MJ, Wee CC, Mukamal KJ, Miller ER, Sacks FM, Appel LJ, Shmerling RH, Choi HK, Juraschek SP. Effects of dietary macronutrients on serum urate: results from the OmniHeart trial. Am J Clin Nutr. 2021 Jun 1;113(6):1593-1599. doi: 10.1093/ajcn/nqaa424.

    PMID: 33668058DERIVED

  • Zhang M, Juraschek SP, Appel LJ, Pasricha PJ, Miller ER 3rd, Mueller NT. Effects of High-Fiber Diets and Macronutrient Substitution on Bloating: Findings From the OmniHeart Trial. Clin Transl Gastroenterol. 2020 Jan;11(1):e00122. doi: 10.14309/ctg.0000000000000122.

    PMID: 31972610DERIVED

  • Mueller NT, Zhang M, Juraschek SP, Miller ER, Appel LJ. Effects of high-fiber diets enriched with carbohydrate, protein, or unsaturated fat on circulating short chain fatty acids: results from the OmniHeart randomized trial. Am J Clin Nutr. 2020 Mar 1;111(3):545-554. doi: 10.1093/ajcn/nqz322.

    PMID: 31927581DERIVED

  • Kovell LC, Yeung EH, Miller ER 3rd, Appel LJ, Christenson RH, Rebuck H, Schulman SP, Juraschek SP. Healthy diet reduces markers of cardiac injury and inflammation regardless of macronutrients: Results from the OmniHeart trial. Int J Cardiol. 2020 Jan 15;299:282-288. doi: 10.1016/j.ijcard.2019.07.102. Epub 2019 Aug 2.

    PMID: 31447226DERIVED

  • Loo RL, Zou X, Appel LJ, Nicholson JK, Holmes E. Characterization of metabolic responses to healthy diets and association with blood pressure: application to the Optimal Macronutrient Intake Trial for Heart Health (OmniHeart), a randomized controlled study. Am J Clin Nutr. 2018 Mar 1;107(3):323-334. doi: 10.1093/ajcn/nqx072.

    PMID: 29506183DERIVED

  • Juraschek SP, Miller ER 3rd, Appel LJ, Christenson RH, Sacks FM, Selvin E. Effects of dietary carbohydrate on 1,5-anhydroglucitol in a population without diabetes: results from the OmniCarb trial. Diabet Med. 2017 Oct;34(10):1407-1413. doi: 10.1111/dme.13391. Epub 2017 Jul 9.

    PMID: 28574153DERIVED

  • Haring B, von Ballmoos MC, Appel LJ, Sacks FM. Healthy dietary interventions and lipoprotein (a) plasma levels: results from the Omni Heart Trial. PLoS One. 2014 Dec 15;9(12):e114859. doi: 10.1371/journal.pone.0114859. eCollection 2014.

    PMID: 25506933DERIVED

  • Gadgil MD, Appel LJ, Yeung E, Anderson CA, Sacks FM, Miller ER 3rd. The effects of carbohydrate, unsaturated fat, and protein intake on measures of insulin sensitivity: results from the OmniHeart trial. Diabetes Care. 2013 May;36(5):1132-7. doi: 10.2337/dc12-0869. Epub 2012 Dec 5.

    PMID: 23223345DERIVED

  • Juraschek SP, Appel LJ, Anderson CA, Miller ER 3rd. Effect of a high-protein diet on kidney function in healthy adults: results from the OmniHeart trial. Am J Kidney Dis. 2013 Apr;61(4):547-54. doi: 10.1053/j.ajkd.2012.10.017. Epub 2012 Dec 4.

    PMID: 23219108DERIVED

  • Furtado JD, Campos H, Sumner AE, Appel LJ, Carey VJ, Sacks FM. Dietary interventions that lower lipoproteins containing apolipoprotein C-III are more effective in whites than in blacks: results of the OmniHeart trial. Am J Clin Nutr. 2010 Oct;92(4):714-22. doi: 10.3945/ajcn.2009.28532. Epub 2010 Sep 8.

    PMID: 20826623DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisHypertension

Interventions

Proteins

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Lawrence Appel

    Johns Hopkins University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were unaware of diet sequence.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Individuals were randomized to a sequence of 3 diets (CARB, UNSAT, PROTEIN)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2003

First Posted

January 13, 2003

Study Start

May 1, 2002

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 4, 2018

Record last verified: 2018-10