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OpenTrials
Completed

NCT Number: NCT01188902

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

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Key information

Conditions

Healthy

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Med Dept. 2 Grosshadern

Munich, 81377, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

walnut

Dietary Supplement

walnut consumption 48 g/d

Primary outcomes

  1. Fasting non-HDL-cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. area under the triglyceride curve (AUC-TG)

    Time frame: 8 weeks

    area under the plasma triglyceride concentration curve following a standardized oral fat challenge

  2. 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

  3. LDL-cholesterol

    Time frame: 8 weeks

    fasting plasma LDL-cholesterol concentration

  4. HDL-cholesterol

    Time frame: 8 weeks

    fasting plasma HDL-cholesterol concentration

  5. triglyceride

    Time frame: 8 weeks

    fasting plasma triglyceride concentration

  6. glucose

    Time frame: 8 weeks

    fasting plasma glucose concentration

  7. HOMA

    Time frame: 8 weeks

  8. insulin

    Time frame: 8 weeks

  9. HbA1c

    Time frame: 8 weeks

  10. area under the glucose curve (AUC-glucose)

    Time frame: 8 weeks

    area under the plasma glucose concentration curve following a standardized oral challenge

  11. area under the insulin curve (AUC-insulin)

    Time frame: 8 weeks

    area under the plasma insulin concentration curve following a standardized oral challenge

  12. endothelial function

    Time frame: 8 weeks

    Postprandial (mixed meal challenge) endothelial function (flow mediated dilatation, flow-independent dilatation)

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 26, 2010
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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