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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klaus Parhofer, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01188902
First received: August 25, 2010
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Fasting non-HDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • area under the triglyceride curve (AUC-TG) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge

  • LDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    fasting plasma LDL-cholesterol concentration

  • HDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    fasting plasma HDL-cholesterol concentration

  • triglyceride [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    fasting plasma triglyceride concentration

  • glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    fasting plasma glucose concentration

  • HOMA [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • insulin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • area under the glucose curve (AUC-glucose) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    area under the plasma glucose concentration curve following a standardized oral challenge

  • area under the insulin curve (AUC-insulin) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    area under the plasma insulin concentration curve following a standardized oral challenge

  • endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188902

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

No publications provided

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
Study First Received: August 25, 2010
Last Updated: January 7, 2013
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

ClinicalTrials.gov processed this record on May 22, 2013