NCT00993278

Brief Summary

The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins) diet versus a low fat (Heart Healthy) diet on cardiovascular health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2008

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

Study Start

First participant enrolled

August 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

October 9, 2009

Last Update Submit

May 13, 2015

Conditions

Cardiovascular HealthObesity

Outcome Measures

Primary Outcomes (1)

  • Endothelial function via Flow-Mediated Dilation (FMD)

    3 months

Secondary Outcomes (3)

  • Systemic inflammatory markers

    3 months

  • Body composition via Dual energy x-ray absorptiometry (DXA)

    3 months

  • Gene expression of adipose tissue

    3 months

Study Arms (2)

Low-Carbohydrate (Modified Atkins) Diet

ACTIVE COMPARATOR
Dietary Supplement: Low-Carbohydrate (Modified Atkins) Diet

Low-Fat (Heart Healthy) Diet

ACTIVE COMPARATOR
Dietary Supplement: Low-Fat (Heart Healthy) Diet

Interventions

Low-Carbohydrate (Modified Atkins) DietDIETARY_SUPPLEMENT

Low-Carbohydrate (Modified Atkins) Diet

Low-Carbohydrate (Modified Atkins) Diet
Low-Fat (Heart Healthy) DietDIETARY_SUPPLEMENT

Low-Fat (Heart Healthy) Diet

Low-Fat (Heart Healthy) Diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • BMI greater than or equal to 30

You may not qualify if:

  • Currently pregnant or lactating
  • Type 2 diabetes
  • Use of oral anti-diabetes medications (with exception of Metformin for control of PCOS)
  • Presence of known peripheral arterial or cardiovascular disease
  • Change in body weight (greater or equal to 3% within the past 3 months)
  • Recent use (within the four weeks prior to screening) of weight loss medications including but not limited to phentermine, sibutramine, orlistat, or over the counter weight loss products
  • History of an eating disorder or significant disordered eating behaviors such as binging/purging, abuse of laxatives or diuretics
  • History of established renal or hepatic disease
  • History of prior bariatric surgery
  • Subjects who report routine tobacco use
  • Subjects on Angiotensin receptor blockers (medications such as but not limited too Adicant, Losartan, Avapro, Diovan, Micardis, Teveten, Candesarten/thiazide, Ibesarten/thiazide, Valsartan/thiazide, Losarten/thiazide, Telmisarten/thiazide, Teveten/thiazide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (5)

  • Ogden CL, Carroll MD, McDowell MA, Flegal KM. Obesity among adults in the United States--no statistically significant change since 2003-2004. NCHS Data Brief. 2007 Nov;(1):1-8.

    PMID: 19389313BACKGROUND

  • Kershaw EE, Flier JS. Adipose tissue as an endocrine organ. J Clin Endocrinol Metab. 2004 Jun;89(6):2548-56. doi: 10.1210/jc.2004-0395.

    PMID: 15181022BACKGROUND

  • Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77. doi: 10.7326/0003-4819-140-10-200405180-00006.

    PMID: 15148063BACKGROUND

  • Brehm BJ, Seeley RJ, Daniels SR, D'Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab. 2003 Apr;88(4):1617-23. doi: 10.1210/jc.2002-021480.

    PMID: 12679447BACKGROUND

  • Phillips SA, Jurva JW, Syed AQ, Syed AQ, Kulinski JP, Pleuss J, Hoffmann RG, Gutterman DD. Benefit of low-fat over low-carbohydrate diet on endothelial health in obesity. Hypertension. 2008 Feb;51(2):376-82. doi: 10.1161/HYPERTENSIONAHA.107.101824. Epub 2008 Jan 14.

    PMID: 18195164BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

DietDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet TherapyNutrition TherapyTherapeutics

Study Officials

  • Caroline M. Apovian, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Pediatrics

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

August 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

US(1)