N/A
N=40
The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome
Metabolic Syndrome · Type 2 Diabetes · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00525629 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Insulin Resistance — 6.06; 5.72 HOMA-IR index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Walnuts (Dietary_supplement); Control (Dietary_supplement)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Christos Mantzoros
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Resistance |
6.06; 5.72 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Metabolic Syndrome is defined as follows:
Central Obesity- for Europid men this is a waist circumference of > 94cm for women >80cm or BMI >30.
Plus 2 of the following 4 factors
- Elevated triglycerides: > 150 mg/dL
- Reduced HDL cholesterol 130mmHg or diastolic BP > 85mmHg or treatment with antihypertensives.
- Raised fasting plasma glucose > 100mg/dL or previously diagnosed type II diabetes.
Exclusion Criteria
- Subjects with diabetes requiring medication or insulin are excluded.
- Subjects with any medical condition or on any treatment, which would interfere with the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, anemia, heart disease, stroke, malabsorption syndromes according to a detailed medical history.
- Present alcoholism or drug abuse or use of medications that could interfere with the study such as corticosteroids, growth hormone, antiretroviral therapy. These conditions will be screened for by a detailed history and systems review.
- Individuals with nut allergy are excluded.
Data sourced from ClinicalTrials.gov (NCT00525629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.