Clinical trial NCT02329067: The Metabolic Effect of Walnuts in Healthy Subjects
Official title: The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism Disorders
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Non-HDL-cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: LDL-cholesterol
timeFrame: 8 weeks
measure: total-cholesterol
timeFrame: 8 weeks
measure: apoB
timeFrame: 8 weeks
measure: triglycerides
timeFrame: 8 weeks
measure: fasting glucose
timeFrame: 8 weeks
measure: HOMA index
timeFrame: 8 weeks
measure: caloric intake
timeFrame: 8 weeks
measure: ratio CH:fat:protein
timeFrame: 8 weeks
measure: ratio SFA:MUFA:PUFA
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Medical Department 2, University Munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Klaus G Parhofer, MD
role: PRINCIPAL_INVESTIGATOR
References: