ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Walnuts on Antioxidant Capacity and Nutritional Status in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00626691
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : February 19, 2009
Sponsor:
Collaborators:
California Walnut Commission
Tufts Medical Center
Information provided by:
Tufts University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goal of this study is to find out if the daily consumption of English walnuts (Juglans regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have a positive effect on antioxidant capacity and nutrient status in a population of healthy adults, aged 50-70 y.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Walnut consumption Not Applicable

Detailed Description:
Epidemiological studies conducted in large populations have consistently shown that increased consumption of plant-based, antioxidant-rich foods, i.e., fruits, vegetables, grains, and nuts, reduces the risk for several chronic diseases. Among the various plants consumed worldwide, English walnuts (Juglans regia L.) have been reported to have the highest antioxidant activity, second only to rosehips (Rosa canina L.). There are a number of different compounds present in walnuts that are known to exhibit antioxidant activity, including vitamin E (as γ-tocopherol), melatonin, and several non-flavonoid polyphenols (e.g., ellagic acid monomers and polymeric ellagitannins). In vitro and ex vivo, studies have demonstrated the ability of walnuts and walnut extracts to increase the resistance of low density lipoprotein (LDL) to oxidation. Walnuts and/or their constituents have also been shown to decrease levels of oxidative stress in diabetic mice and increase serum antioxidant capacity in rats2. In humans, in vivo antioxidant capacity changes after consuming walnuts have only been measured in subjects with Type 2 diabetes. The antioxidant capacity of the lipophilic compartments, as well as the cooperative/synergistic interactions between the water- and fat-soluble antioxidants present in plasma after walnut consumption have not been measured. Indeed, there have been no studies conducted to date of the effect of walnut consumption on the total antioxidant capacity of healthy men and women. The goal of our proposed study is to determine if consuming walnuts in amounts readily incorporated into the diet can affect the antioxidant capacity of older adults.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Walnuts on Antioxidant Capacity and Nutritional Status in Humans
Study Start Date : February 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Behavioral: Walnut consumption
    Subjects will be randomized to receive either 0.75 oz (22.5 g) or 1.5 oz (45 g) of walnuts daily for the first 6 wk period, followed by a 6 wk washout period, and an additional 6 wk period during which they will receive the reverse dose of walnuts daily. Each serving of walnuts will be pre-weighed and pre-packaged.

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Nutritional status and antioxidant capacity [ Time Frame: 5 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Generally healthy men and postmenopausal women age 50 or over
  • BMI 18.5-35 kg/m2

Exclusion Criteria:

  • Cigarette smoking and/or nicotine replacement use
  • History or known allergy to nuts of any kind
  • Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
  • Individuals taking estrogen
  • Use of cholesterol-lowering medications
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, untreated thyroid disease
  • Rheumatoid arthritis
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg
  • Regular use of oral steroids
  • Regular daily intake of ≥ 2 alcoholic drinks
  • Illicit drug use
  • No fish oil supplements (including cod liver oil) for 6 weeks prior to study admission
  • No high dose (≥ 3X RDA) supplements of vitamins C, E, selenium, or beta-carotene for one month prior to study admission
  • No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission
  • No regular consumption of pomegranate juice (≥ 180 mL or 6 oz/d, ≥ 3 times/wk) for one month prior to study admission
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00626691


Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
California Walnut Commission
Tufts Medical Center
Investigators
Principal Investigator: Diane L McKay, PhD Tufts Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Diane McKay, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
ClinicalTrials.gov Identifier: NCT00626691     History of Changes
Other Study ID Numbers: PV2707
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

Keywords provided by Tufts University:
antioxidant
walnut
nutritional status
Antioxidant capacity

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs