Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Avocado Consumption on Vascular Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595607
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Hass Avocado Board
Information provided by (Responsible Party):
Janet Novotny, USDA Beltsville Human Nutrition Research Center

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date February 24, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Change in Endothelial Function [ Time Frame: 0 hr and 3 hr at baseline and after 6 weeks ]
Noninvasive endothelial function will be assessed, following a 12-hours fast, by measuring endothelium-dependent flow mediated dilation of the peripheral bed. Participants will then consume a test meal and endothelial function will be assessed again 3 hours later.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Change in Blood Pressure [ Time Frame: Baseline and after 6 weeks ]
    Blood pressure will be measured using a standardized protocol at the beginning and end of the intervention.
  • Change in Gene Expression [ Time Frame: Baseline and after 6 weeks ]
    Blood samples will be used to test how the intervention affects gene expression. The expression of genes related to cardiovascular disease risk will be measured at the beginning and end of the 6-week intervention (fasted and post-prandially).
  • Change in Biomarkers of Cardiovascular Disease Risk [ Time Frame: Baseline and after 6 weeks ]
    Blood will be collected at the beginning and end of the dietary intervention, following the endothelial function measurements (fasted and post-prandial collections). Blood will be assessed for biomarkers of cardiovascular disease risk, including electrolytes (sodium, potassium, chloride), markers of inflammation (IL-6, IL-10, IL-1 beta, C-reactive protein, TNF-alpha, fibrinogen, ICAM), markers of vascular function (endothelin-1, factor VII, plasminogen), and blood lipid panel (plasma total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Avocado Consumption on Vascular Health
Official Title  ICMJE The Influence of Daily Consumption of Avocado on Biomarkers of Vascular Health
Brief Summary The study will investigate the effect of avocado consumption on markers of vascular health. Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be utilized. Participants will either receive a typical American diet, or a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat, to allow the isoenergetic inclusion of avocado.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Focus: Avocado Consumption & Vascular Health
Intervention  ICMJE Other: Diet Treatment
Participants will consume a controlled diet for 6 weeks where all meals will be provided by the facility. Participants will be instructed to eat all foods and only foods provided to them.
Study Arms  ICMJE
  • Active Comparator: Typical American Diet
    Participants will receive a typical American diet for 6 weeks.
    Intervention: Other: Diet Treatment
  • Experimental: Avocado Diet
    Participants will receive a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat to allow the inclusion of avocado.
    Intervention: Other: Diet Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI between 25 and 42 kg/m2
  • Age 28 to 70 years during the intervention
  • Fasting glucose ≤ 126 mg/dl
  • Blood pressure ≤ 160/100 mm Hg

Exclusion Criteria:

  • Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes
  • Women who have given birth during the previous 12 months
  • Pregnant women or women who plan to become pregnant or become pregnant during the study
  • Lactating women
  • Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
  • Volunteers who have lost 10% of body weight within the last 12 months
  • Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity
  • Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
  • Smokers or other tobacco users (during the 6 months prior to the start of the study)
  • Unable or unwilling to give informed consent or communicate with study staff
  • Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595607
Other Study ID Numbers  ICMJE HS39
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janet Novotny, USDA Beltsville Human Nutrition Research Center
Study Sponsor  ICMJE USDA Beltsville Human Nutrition Research Center
Collaborators  ICMJE Hass Avocado Board
Investigators  ICMJE Not Provided
PRS Account USDA Beltsville Human Nutrition Research Center
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP