The Metabolic Effect of Walnuts in Healthy Subjects

Not Applicable

Completed

• Conditions: Lipid Metabolism Disorders
• Interventions: Other: walnuts

• Registration Number: NCT02329067
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Primary Completion: 2016-07
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
walnut-CH	walnuts	Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates
Walnut-SFA	walnuts	Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids
Walnut-LIB	walnuts	Western type diet including walnuts (43g/day); no specific recommendation

Primary Outcome Measures

Name	Time	Method
Non-HDL-cholesterol	8 weeks

Secondary Outcome Measures

Name	Time	Method
HOMA index	8 weeks
total-cholesterol	8 weeks
LDL-cholesterol	8 weeks
ratio SFA:MUFA:PUFA	8 weeks
apoB	8 weeks
triglycerides	8 weeks
fasting glucose	8 weeks
caloric intake	8 weeks
ratio CH:fat:protein	8 weeks

Trial Locations

Locations (1)

Medical Department 2, University Munich; 🇩🇪 Munich, Germany