The Metabolic Effect of Walnuts in Healthy Subjects

Lipid Metabolism Disorders Clinical Trial

— WALDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329067
• Other study ID #: WALNUT-2
• Status: Completed
• Phase: N/A
• First received: December 29, 2014
• Last updated: August 28, 2017
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• walnuts
consumption of 43 g walnuts per day

Locations

Country	Name	City	State
Germany	Medical Department 2, University Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-HDL-cholesterol		8 weeks
Secondary	LDL-cholesterol		8 weeks
Secondary	total-cholesterol		8 weeks
Secondary	apoB		8 weeks
Secondary	triglycerides		8 weeks
Secondary	fasting glucose		8 weeks
Secondary	HOMA index		8 weeks
Secondary	caloric intake		8 weeks
Secondary	ratio CH:fat:protein		8 weeks
Secondary	ratio SFA:MUFA:PUFA		8 weeks