- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307628
Response of Gut Microbiota and Cardiometabolic Biomarkers to Consumption of Walnuts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Ragle Human Nutrition Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Generally healthy men and women between 20-65 years of age and BMI range of 20.0-34.9 kg/m2 will be recruited from the Davis - Sacramento metropolitan area. Enrolled subjects must be willing to consume 2 ounces (approximately 1/2 cup) of walnuts daily and modify their diet to avoid eating walnuts and other nuts, and foods or beverages high in polyphenols (a list will be provided) during study enrollment . Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant or lactating women, women planning to become pregnant in the next four months and prisoners will be specifically excluded. Screening will take place by phone interview and through in-person screening and consent, including anthropometric and biochemical assessments and health history questionnaires.
Exclusion Criteria:
- Allergy to walnuts or other nuts
- Eating more than 25 grams of fiber per day, assessed by the Block Dietary-Fruit-Vegetable-Fiber Screener©
- Taking medications or supplements known to affect metabolism or gut microbiota composition (i.e. Metformin, statins, antibiotics within the past 3 months, fiber supplements, probiotics, and others)
- Documented chronic diseases including diabetes, renal or liver disease, metabolic syndrome, active cancer, MI or stroke, history of gastric bypass or GI disease (e.g. Crohn's Disease, Irritable Bowel Disease, diverticulosis/diverticulitis,etc)
- Smoker or living with a smoker, including vaporizer and/or electronic cigarettes.
- Illicit drug use, cannabis usage, or consuming >1 alcoholic drink/day
- Extreme dietary or exercise patterns; vegan diet.
- Recent weight fluctuations (>10% in the last 6 months)
- Taking prescription lipid medications or supplements that may affect lipoprotein metabolism (i.e. >1 g of fish oil/day, antioxidant supplements)
- Taking exogenous hormones (e.g. hormonal birth control)
- Poor venous access
- Unwillingness to comply with study protocols
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Walnut
Eat 2 ounces of walnuts provided by the study.
Eating any other nuts is to be avoided.
Background diet will be low in polyphenols.
|
Study participants will eat 2 ounces of walnuts each day.
|
Placebo Comparator: Nut-Free
Eating any other nuts is to be avoided.
Background diet will be low in polyphenols.
|
Study participants will not eat nuts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the influence of walnuts on the fecal metagenome
Time Frame: Through study completion, an average of 12 weeks
|
Changes in fecal metagenomics will be assessed via Illumina sequencing
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on fecal secondary bile acids
Time Frame: Through study completion, an average of 12 weeks
|
Fecal secondary bile acids will be measured by LC-QTOF/MS
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on fecal short-chain fatty acids
Time Frame: Through study completion, an average of 12 weeks
|
Short-chain fatty acids in fecal matter will be measured by LC-MS/MS
|
Through study completion, an average of 12 weeks
|
Urolithins measured in plasma by UPLC/MS
Time Frame: Through study completion, an average of 12 weeks
|
Measure for changes in the levels of urolithins in separated plasma; measured in units of ug/uL.
Blood will be assessed at each of the 4 study visits.
|
Through study completion, an average of 12 weeks
|
Fecal calprotectin will be measured by ELISA
Time Frame: Through study completion, an average of 12 weeks
|
Measure for changes in the levels of calprotectin in collected fecal matter; measured in units of ug/g.
Feces will be assessed at each of the 4 study visits.
|
Through study completion, an average of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the influence of walnuts on blood lipid measurements
Time Frame: Through study completion, an average of 12 weeks
|
Measure for changes in the levels of HDL and LDL in separated plasma; measured in units of mg/dL.
Blood will be assessed at each of the 4 study visits
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on paraoxonase-1 (PON-1) activity
Time Frame: Through study completion, an average of 12 weeks
|
Measure for changes in PON-1 activity in separated plasma at each study of the 4 study visits.
Activity will be calculated based on linear rates of hydrolysis of phenyl acetate to phenol
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on cholesterol ester transfer protein activity (CETP)
Time Frame: Through study completion, an average of 12 weeks
|
Changes in CETP activity will be measured at each of the 4 study visits.
The isolated plasma will be co-incubated with donor and acceptor molecules using a commercially available assay kit.
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on hsCRP will be measured in blood
Time Frame: Through study completion, an average of 12 weeks
|
hsCRP will be measured in blood at each study visit
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on SAA will be measured in blood
Time Frame: Through study completion, an average of 12 weeks
|
SAA will be measured in blood at each study visit
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on circulating cytokines
Time Frame: Through study completion, an average of 12 weeks
|
ICAM and VCAM will be measured in blood at each study visit using a commercially available ELISA kit.
|
Through study completion, an average of 12 weeks
|
Assessing the influence of walnuts on peripheral blood mononuclear cells (PBMC) using ex vivo stimulation assays
Time Frame: Through study completion, an average of 12 weeks
|
In-vitro: media from LPS stimulated monocytes will be used to measure gene expression and cytokines Measurement of changes in PBMC derived cytokines as a marker of inflammation at each of the 4 study visits.
Assessment will be based on an increase or decrease in concentration in pg/ml.
|
Through study completion, an average of 12 weeks
|
Dietary record analysis
Time Frame: Through study completion, an average of 12 weeks
|
Use a computer program to check for study dietary requirements.
Subjects are to avoid olives and olive containing products during study protocol periods.
This will be done using a subject self-recorded 3-day food record submitted to study personnel.
|
Through study completion, an average of 12 weeks
|
Anthropometric measurements
Time Frame: Through study completion, an average of 12 weeks
|
Measure waist (cm) and hip circumference (cm) before the start of drawing blood on study day protocols.
|
Through study completion, an average of 12 weeks
|
Measure for changes in weight
Time Frame: Through study completion, an average of 12 weeks
|
Measure weight (kg) before the start of drawing blood on study day protocols
|
Through study completion, an average of 12 weeks
|
Measure for changes in blood pressure
Time Frame: Through study completion, an average of 12 weeks
|
Measure blood pressure (mmHg) before the start of drawing blood on study day protocols
|
Through study completion, an average of 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francene M Steinberg, PhD, RD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1562149
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Walnut
-
Penn State UniversityCalifornia Walnut CommissionCompletedCardiovascular DiseaseUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedMetabolic SyndromeUnited States
-
Griffin HospitalCompleted
-
Isfahan University of Medical SciencesCompletedCardiovascular Risk Factor and Kidney Related Biomarkers
-
Jonathan SpergelUniversity of ArkansasWithdrawn
-
Penn State UniversityCalifornia Walnut CommissionCompletedCardiovascular DiseaseUnited States
-
University of North Carolina, Chapel HillWithdrawnNut Hypersensitivities
-
Ludwig-Maximilians - University of MunichCompleted
-
University of ArizonaCalifornia Walnut CommissionCompletedBreast FeedingUnited States