The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT00525629|
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : February 23, 2017
Last Update Posted : December 15, 2017
Walnuts include many potentially beneficial micronutrients and phytochemicals, in this study we propose to examine the effects of walnuts independent of macronutrient content. The purpose of this proposal is to study in depth the short-term effects of walnut consumption in men and women with the metabolic syndrome.
Study Aim 1: To investigate the effects of walnuts (48gms per day over 3 days) on insulin resistance in subjects with the metabolic syndrome.
Study Aim 2: To investigate the effects of 48gms per day of walnuts over 3 days on lipids and inflammatory markers.
Study Aim 3: To assess the possible mechanisms of the biological effects of short-term walnut consumption through assessment of adipokines, resting metabolic rate, gene expression in white blood cells and the effect of walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the excretion of gut peptides and free fatty acids.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Type 2 Diabetes Cardiovascular Disease||Dietary Supplement: Walnuts Dietary Supplement: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: Walnut Diet
48 Grams of Walnuts Daily
Dietary Supplement: Walnuts
48 Grams of Walnuts Daily
Placebo Comparator: Control Diet
Isocaloric Diet with No Walnuts
Dietary Supplement: Control
Control Diet with No Walnuts
- Insulin Resistance [ Time Frame: 4 days ]HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.
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): NCT00525629
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Christos S Mantzoros, MD||Beth Israel Deaconess Medical Center|