The Metabolic Effect of Walnuts in Healthy Subjects (WALDI)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Lipid Metabolism Disorders

Treatments: Other: walnuts

Study type: Interventional

Funder types: Other

Identifiers

NCT02329067

WALNUT-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

walnut-CH

Experimental group

Description:

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

Treatment:

Other: walnuts

Walnut-SFA

Experimental group

Description:

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

Treatment:

Other: walnuts

Walnut-LIB

Experimental group

Description:

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

Treatment:

Other: walnuts

Control

No Intervention group

Description:

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