Overview

This trial is active, not recruiting.

Condition lipid metabolism disorders
Treatment walnuts
Sponsor Ludwig-Maximilians - University of Munich
Start date December 2014
End date July 2016
Trial size 180 participants
Trial identifier NCT02329067, WALNUT-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates
walnuts
consumption of 43 g walnuts per day
(Experimental)
Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids
walnuts
consumption of 43 g walnuts per day
(Experimental)
Western type diet including walnuts (43g/day); no specific recommendation
walnuts
consumption of 43 g walnuts per day
(No Intervention)
Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind

Primary Outcomes

Measure
Non-HDL-cholesterol
time frame: 8 weeks

Secondary Outcomes

Measure
LDL-cholesterol
time frame: 8 weeks
total-cholesterol
time frame: 8 weeks
apoB
time frame: 8 weeks
triglycerides
time frame: 8 weeks
fasting glucose
time frame: 8 weeks
HOMA index
time frame: 8 weeks
caloric intake
time frame: 8 weeks
ratio CH:fat:protein
time frame: 8 weeks
ratio SFA:MUFA:PUFA
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 50 years old.

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)

Additional Information

Official title The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components
Principal investigator Klaus G Parhofer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.