The Metabolic Effect of Walnuts in Healthy Subjects

NCT ID: NCT02329067

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-07-31

Brief 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.

Detailed 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.

Conditions

Lipid Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

walnut-CH

Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates

Group Type: EXPERIMENTAL

walnuts

Intervention Type: OTHER

consumption of 43 g walnuts per day

Walnut-SFA

Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids

Group Type: EXPERIMENTAL

walnuts

Intervention Type: OTHER

consumption of 43 g walnuts per day

Walnut-LIB

Western type diet including walnuts (43g/day); no specific recommendation

Group Type: EXPERIMENTAL

walnuts

Intervention Type: OTHER

consumption of 43 g walnuts per day

Control

Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

walnuts

consumption of 43 g walnuts per day

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Klaus Parhofer

professor of Endocrinology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus G Parhofer, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Medical Department 2, University Munich

Munich, , Germany

Countries

Germany

Other Identifiers

WALNUT-2

Identifier Type: -

Identifier Source: org_study_id