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The Metabolic Effect of Walnuts in Healthy Subjects (WALDI)

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ClinicalTrials.gov Identifier: NCT02329067
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Klaus Parhofer, 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.

Condition or disease Intervention/treatment Phase
Lipid Metabolism Disorders Other: walnuts Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components
Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: walnut-CH
Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates
Other: walnuts
consumption of 43 g walnuts per day

Experimental: Walnut-SFA
Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids
Other: walnuts
consumption of 43 g walnuts per day

Experimental: Walnut-LIB
Western type diet including walnuts (43g/day); no specific recommendation
Other: walnuts
consumption of 43 g walnuts per day

No Intervention: Control
Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind



Primary Outcome Measures :
  1. Non-HDL-cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: 8 weeks ]
  2. total-cholesterol [ Time Frame: 8 weeks ]
  3. apoB [ Time Frame: 8 weeks ]
  4. triglycerides [ Time Frame: 8 weeks ]
  5. fasting glucose [ Time Frame: 8 weeks ]
  6. HOMA index [ Time Frame: 8 weeks ]
  7. caloric intake [ Time Frame: 8 weeks ]
  8. ratio CH:fat:protein [ Time Frame: 8 weeks ]
  9. ratio SFA:MUFA:PUFA [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329067


Locations
Germany
Medical Department 2, University Munich
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Klaus G Parhofer, MD Ludwig-Maximilians - University of Munich

Responsible Party: Klaus Parhofer, professor of Endocrinology and Metabolism, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02329067     History of Changes
Other Study ID Numbers: WALNUT-2
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Metabolic Diseases
Lipid Metabolism Disorders