NCT01188902

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

August 25, 2010

Last Update Submit

January 7, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Fasting non-HDL-cholesterol

    8 weeks

Secondary Outcomes (12)

  • area under the triglyceride curve (AUC-TG)

    8 weeks

  • incremental area under the triglyceride curve (iAUC-TG)

    8 weeks

  • LDL-cholesterol

    8 weeks

  • HDL-cholesterol

    8 weeks

  • triglyceride

    8 weeks

  • +7 more secondary outcomes

Study Arms (2)

walnut

EXPERIMENTAL

western type diet with 48 g walnut per day

Dietary Supplement: walnut

control

NO INTERVENTION

Interventions

walnutDIETARY_SUPPLEMENT

walnut consumption 48 g/d

walnut

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med Dept. 2 Grosshadern

Munich, 81377, Germany

Location

MeSH Terms

Interventions

PR-10 protein, walnut birch pollen

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

DE(1)