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The Metabolic Effect of Walnuts in Healthy Subjects (WALDI)

Primary Purpose

Lipid Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
walnuts
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lipid Metabolism Disorders

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Medical Department 2, University Munich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

walnut-CH

Walnut-SFA

Walnut-LIB

Control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Non-HDL-cholesterol

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2014
Last Updated
August 28, 2017
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02329067
Brief Title
The Metabolic Effect of Walnuts in Healthy Subjects
Acronym
WALDI
Official Title
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
walnut-CH
Arm Type
Experimental
Arm Description
Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates
Arm Title
Walnut-SFA
Arm Type
Experimental
Arm Description
Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids
Arm Title
Walnut-LIB
Arm Type
Experimental
Arm Description
Western type diet including walnuts (43g/day); no specific recommendation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind
Intervention Type
Other
Intervention Name(s)
walnuts
Intervention Description
consumption of 43 g walnuts per day
Primary Outcome Measure Information:
Title
Non-HDL-cholesterol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
LDL-cholesterol
Time Frame
8 weeks
Title
total-cholesterol
Time Frame
8 weeks
Title
apoB
Time Frame
8 weeks
Title
triglycerides
Time Frame
8 weeks
Title
fasting glucose
Time Frame
8 weeks
Title
HOMA index
Time Frame
8 weeks
Title
caloric intake
Time Frame
8 weeks
Title
ratio CH:fat:protein
Time Frame
8 weeks
Title
ratio SFA:MUFA:PUFA
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus G Parhofer, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department 2, University Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

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The Metabolic Effect of Walnuts in Healthy Subjects

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