Completed

Macronutrient Absorption From Walnuts: The Measured Energy Value of Walnuts in the Human Diet

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What is being tested

Walnut Diet

+ Control Diet

+ Walnut Diet

Other
Who is being recruted

From 25 to 65 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUSDA Beltsville Human Nutrition Research Center
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Previous studies have demonstrated that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. The aim of this study is to determine the energy value of walnuts in the human diet and to probe mechanisms by which walnuts impart health benefits. The metabolizable energy value of walnuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of walnuts than simply calculating energy value based on Atwater factors. In addition to determining the energy value of walnuts, we will evaluate the effects of walnut-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by walnut consumption.

NCT01832909
Principal SponsorUSDA Beltsville Human Nutrition Research Center
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Age 25 to 65 years at beginning of study
Blood pressure < 160/100 (controlled with certain medications)
Body mass index between 20 and 38 kg/m2
Fasting glucose < 126 mg/dl
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14 exclusion criteria prevent from participating
Antibiotic use during the intervention or for 3 weeks prior to any intervention period
History of bariatric or certain other surgeries related to weight control
History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
Known (self-reported) allergy or adverse reaction to walnuts or other nuts
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Controlled diet with 1.5 oz/d of walnuts, followed by controlled diet without walnuts.

Group II

Experimental
Controlled diet without almonds first (control), then controlled diet with 1.5 oz/d of almonds.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

USDA Beltsville Human Nutrition Research Center

Beltsville, United StatesOpen USDA Beltsville Human Nutrition Research Center in Google Maps
CompletedOne Study Center