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The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women

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: NCT01188902
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
Klaus Parhofer, Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date  ICMJE August 25, 2010
First Posted Date  ICMJE August 26, 2010
Last Update Posted Date January 8, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
Fasting non-HDL-cholesterol [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
  • area under the triglyceride curve (AUC-TG) [ Time Frame: 8 weeks ]
    area under the plasma triglyceride concentration curve following a standardized oral fat challenge
  • incremental area under the triglyceride curve (iAUC-TG) [ Time Frame: 8 weeks ]
    incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge
  • LDL-cholesterol [ Time Frame: 8 weeks ]
    fasting plasma LDL-cholesterol concentration
  • HDL-cholesterol [ Time Frame: 8 weeks ]
    fasting plasma HDL-cholesterol concentration
  • triglyceride [ Time Frame: 8 weeks ]
    fasting plasma triglyceride concentration
  • glucose [ Time Frame: 8 weeks ]
    fasting plasma glucose concentration
  • HOMA [ Time Frame: 8 weeks ]
  • insulin [ Time Frame: 8 weeks ]
  • HbA1c [ Time Frame: 8 weeks ]
  • area under the glucose curve (AUC-glucose) [ Time Frame: 8 weeks ]
    area under the plasma glucose concentration curve following a standardized oral challenge
  • area under the insulin curve (AUC-insulin) [ Time Frame: 8 weeks ]
    area under the plasma insulin concentration curve following a standardized oral challenge
  • endothelial function [ Time Frame: 8 weeks ]
    Postprandial (mixed meal challenge) endothelial function (flow mediated dilatation, flow-independent dilatation)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
postprandial lipids [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
Official Title  ICMJE The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
Brief Summary The objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Dietary Supplement: walnut
walnut consumption 48 g/d
Study Arms  ICMJE
  • Experimental: walnut
    western type diet with 48 g walnut per day
    Intervention: Dietary Supplement: walnut
  • No Intervention: control
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: August 25, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal healthy women and healthy men
  • Age > 50 yrs

Exclusion Criteria:

  • Evidence of alcohol, tabacco or drug abuse
  • Obesity ≥ 35 kg/m2
  • Diabetes mellitus
  • Hypertension
  • LDL-cholesterol > 190 mg/dl, Triglycerides > 350 mg/dl
  • History of atherosclerotic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188902
Other Study ID Numbers  ICMJE Walnut-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Klaus Parhofer, Ludwig-Maximilians - University of Munich
Study Sponsor  ICMJE Ludwig-Maximilians - University of Munich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ludwig-Maximilians - University of Munich
Verification Date January 2013

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