The Metabolic Effect of Walnuts in Healthy Subjects
WALDI
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 29, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 29, 2017
August 1, 2017
1.6 years
December 29, 2014
August 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Non-HDL-cholesterol
8 weeks
Secondary Outcomes (9)
LDL-cholesterol
8 weeks
total-cholesterol
8 weeks
apoB
8 weeks
triglycerides
8 weeks
fasting glucose
8 weeks
- +4 more secondary outcomes
Study Arms (4)
walnut-CH
EXPERIMENTALWestern type diet including walnuts (43g/day); Walnuts substitute carbohydrates
Walnut-SFA
EXPERIMENTALWestern type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids
Walnut-LIB
EXPERIMENTALWestern type diet including walnuts (43g/day); no specific recommendation
Control
NO INTERVENTIONIsocaloric western type diet w/o nuts, nut butters or nut oils of any kind
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal healthy women and healthy men
- Age \>50 yrs
- Written informed consent prior to study participation
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Department 2, University Munich
Munich, 81377, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus G Parhofer, MD
Ludwig-Maximilians - University of Munich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of Endocrinology and Metabolism
Study Record Dates
First Submitted
December 29, 2014
First Posted
December 31, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2017
Last Updated
August 29, 2017
Record last verified: 2017-08