Ragle Human Nutrition Center
Davis, California, 95616, United States
NCT Number: NCT05321277
The purpose of this research is to test if eating walnuts will cause any changes in blood lipids (like good and bad cholesterol, for example) and levels of inflammation in the blood, as well as changes in the bacteria living in the gut.
This study is active but is not currently recruiting participants.
Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
The purpose of this research is to test if eating walnuts will cause any changes in blood lipids (like good and bad cholesterol, for example) and levels of inflammation in the blood, as well as changes in the bacteria living in the gut. Overweight/obese adults between the ages of 45 and 70 yo with elevated LDL-C levels are eligible to participate. The study involves 5 visits (1 initial screening and 4 study visits) and will last about 10 weeks. There is a 1-week run-in period before starting the study, followed by two diet intervention periods each lasting 3 weeks, separated by a 3-week washout period.
Participation in this study will involve an initial 1-week run in period to become accustomed to the study diet. After this 1 week period, participants will be randomly selected to start either a walnut or a no-nut diet. During each phase of the study, participants will be asked to come to the University of California, Davis campus after a 10-12 hour overnight fast. At each visit, body measurements will be taken; blood, urine and fecal samples will be collected.
During the 10 weeks of the study, all nuts and nut-derived products will need to be avoided. The study will provide walnuts to be eaten at home for each intervention phase. Additionally, the investigators will ask that ellagitannin-rich foods, high-fiber and fermented foods be avoided in the diet. Detailed food diaries will be filled out and brought to study visits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional exclusion criteria are listed below:
Participants will consume 56 g of walnuts daily for 3 weeks. Participants will also follow a diet devoid of ellagitannin-rich, high fiber, and fermented foods.
Participants will exclude all nuts and nut-derived products; high-fiber, fermented and ellagitannin-rich foods will also be excluded.
Time frame: Through study completion, an average of 10 weeks
Measure for changes in the levels of HDL and LDL in separated plasma; measured in units of mg/dL. Blood will be assessed for the fasting (baseline) sample at each of the 4 study visits.
Time frame: Through study completion, an average of 10 weeks
Measure circulating inflammatory markers in separated plasma at each of the 4 study visits. Commercially available ELISA kits will be used: PAI-1, VCAM-1, ICAM-1.
Time frame: Through study completion, an average of 10 weeks
Measure blood pressure (mmHg) before the start of drawing blood on study day protocols.
Time frame: Through study completion, an average of 10 weeks
Measure fecal pH via pH meter at each of the 4 study visits.
Time frame: Through study completion, an average of 10 weeks
Assess fecal consistency using Bristol Stool Scale at each of the 4 study visits. The scale runs from Type 1 (the lowest) to Type 7 (the highest). The desirable Type is either 3 or 4. Types 1 and 2 may be indicative of constipation, while Types 5, 6, and 7 may indicative diarrhea.
Time frame: Through study completion, an average of 10 weeks
Measure fecal moisture by weighing wt and vacuum dried feces in grams at each of the 4 study visits.
Time frame: Through study completion, an average of 10 weeks
Measure fecal levels of Lipocalin-2 and calprotectin at each of the 4 study visits. Commercially available ELISA kits will be used: lipocalin-2, calprotectin.
Time frame: Through study completion, an average of 10 weeks
Measure urolithin levels in separated plasma and urine via metabolomics analysis at each of the 4 study visits.
Time frame: Through study completion, an average of 10 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.
Time frame: Through study completion, an average of 10 weeks
Measure waist (cm) and hip circumference (cm) before the start of drawing blood on study day protocols.
Time frame: Through study completion, an average of 10 weeks
Measure weight (kg) before the start of drawing blood on study day protocols.
University of California, Davis
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04617834
Acute Coronary Syndrome, Cardiovascular Diseases
Wilkesboro, North Carolina, United States
View Trial DetailsNCT05198674
Cardiovascular Diseases, Chronic Disease
Birmingham, Alabama, United States
View Trial DetailsNCT04053088
Cardiovascular Diseases
Innsbruck, Austria
View Trial DetailsNCT03433274
Cardiovascular Diseases, Degenerative Mitral Valve Disease
Birmingham, Alabama, United States
View Trial Details