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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: walnut

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • Med Dept. 2 Grosshadern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: walnut; western type diet with 48 g walnut per day	Dietary supplement: walnut; walnut consumption 48 g/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting non-HDL-cholesterol	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c		8 weeks
insulin		8 weeks
area under the triglyceride curve (AUC-TG)	area under the plasma triglyceride concentration curve following a standardized oral fat challenge	8 weeks
incremental area under the triglyceride curve (iAUC-TG)	incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge	8 weeks
LDL-cholesterol	fasting plasma LDL-cholesterol concentration	8 weeks
HDL-cholesterol	fasting plasma HDL-cholesterol concentration	8 weeks
triglyceride	fasting plasma triglyceride concentration	8 weeks
glucose	fasting plasma glucose concentration	8 weeks
HOMA		8 weeks
area under the glucose curve (AUC-glucose)	area under the plasma glucose concentration curve following a standardized oral challenge	8 weeks
area under the insulin curve (AUC-insulin)	area under the plasma insulin concentration curve following a standardized oral challenge	8 weeks
endothelial function	Postprandial (mixed meal challenge) endothelial function (flow mediated dilatation, flow-independent dilatation)	8 weeks

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: Walnut-2010