Skip to main content
OpenTrials
Completed

NCT Number: NCT02329067

The Metabolic Effect of Walnuts in Healthy Subjects

The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Department 2, University Munich

Munich, 81377, Germany

About this study

The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.

The metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.

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
  • Written informed consent prior to study participation

Exclusion criteria

  • Known allergy to nuts
  • Evidence of alcohol (women >70g/week, men >140g/week), tabacco or drug abuse
  • Obesity ≥35 kg/m2
  • Diabetes mellitus
  • Hypertension >140/90 mmHg or history of hypertension
  • LDL-cholesterol >190 mg/dl, Triglycerides > 350 mg/dl
  • History of atherosclerotic disease
  • Liver disease of any etiology
  • Kidney disease of any etiology (GFR < 60 ml/min/1.73)
  • Uncontrolled thyroid disease or other endocrine diseases
  • Acute or chronic inflammatory diseases
  • Active malignancy
  • Current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin E, hormonal replacement therapy
  • major surgical intervention within 3 months (or planned)

Treatment and study plan

Walnuts

Other

consumption of 43 g walnuts per day

Primary outcomes

  1. Non-HDL-cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. LDL-cholesterol

    Time frame: 8 weeks

  2. total-cholesterol

    Time frame: 8 weeks

  3. apoB

    Time frame: 8 weeks

  4. triglycerides

    Time frame: 8 weeks

  5. fasting glucose

    Time frame: 8 weeks

  6. HOMA index

    Time frame: 8 weeks

  7. caloric intake

    Time frame: 8 weeks

  8. ratio CH:fat:protein

    Time frame: 8 weeks

  9. ratio SFA:MUFA:PUFA

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components

Acronym: WALDI

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 31, 2014
Registry last updated
Aug 29, 2017

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.

Published trials that share one or more normalized conditions with this study.