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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01188902
First Posted: August 26, 2010
Last Update Posted: January 8, 2013
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.
Information provided by (Responsible Party):
Klaus Parhofer, Ludwig-Maximilians - University of Munich
  Purpose
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

Condition Intervention
Healthy Dietary Supplement: walnut

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women

Further study details as provided by Klaus Parhofer, Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Fasting non-HDL-cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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)


Enrollment: 60
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: walnut
western type diet with 48 g walnut per day
Dietary Supplement: walnut
walnut consumption 48 g/d
No Intervention: control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188902


Locations
Germany
Med Dept. 2 Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
  More Information

Responsible Party: Klaus Parhofer, Professor of Medicine, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01188902     History of Changes
Other Study ID Numbers: Walnut-2010
First Submitted: August 25, 2010
First Posted: August 26, 2010
Last Update Posted: January 8, 2013
Last Verified: January 2013