Oregon State University
Corvallis, Oregon, 97331, United States
NCT Number: NCT05790564
Almonds are a good source of beneficial compounds. This study will investigate if eating almonds everyday for 12 weeks can affect gut health and inflammation in persons with metabolic syndrome. Investigators will measure changes in metabolism, heart health, and the levels of vitamins and other compounds from almonds.
This study is active but is not currently recruiting participants.
Notify Me35 year–60 year
All sexes
Interventional
Not applicable
Corvallis, Oregon, 97331, United States
Metabolic Syndrome (MetS) affects over a billion people world-wide. MetS progression and further health complications are driven by chronic inflammation. Major causes of inflammation in MetS are gut barrier breakdown and the absorption of harmful bacteria. What causes the gut barrier breakdown is not clear, but a poor diet, especially low micronutrient intakes like vitamin E, is implicated by propagating a vicious cycle that promotes oxidative stress, inflammation and further gut barrier damage. This study will assess the impact of daily consumption of 2 ounces of almonds for 12 weeks on gut health, markers of inflammation and cardiometabolic health, and micronutrient status in persons with MetS.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
Time frame: 0 and 4 weeks
Change from baseline at week 4: Marker of gut barrier function and health, serum endotoxin
Time frame: 0 and 4 weeks
Change from baseline at week 4: Markers of gut barrier function and health fecal short chain fatty acids profiles
Time frame: 0 and 4 weeks
Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase
Time frame: 0 and 4 weeks
Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6)
Time frame: 0 and 4 weeks
Change from baseline at week 4: Plasma malondialdehyde
Time frame: 0 and 4 weeks
Change from baseline at week 4: Urinary isoprostanes
Time frame: 0 and 12 weeks
Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides
Time frame: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Plasma α-tocopherols
Time frame: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (α-CEHC)
Time frame: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Systolic, and diastolic blood pressure
Time frame: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Weight
Time frame: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: BMI (weight and height will be combined to report BMI in kg/m^2)
Time frame: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Waist circumference
Time frame: 0 and 12 weeks
Change from baseline at week 12: Fasting blood glucose
Time frame: 0 and 12 weeks
Change from baseline at week 12: Insulin
Time frame: 0 and 12 weeks
Change from baseline at week 12: HOMA-IR
Time frame: 0 and 12 weeks
Change from baseline at week 12: Urinary metabolites of flavonoids like (+)-catechin, (-)-epicatechin and naringenin
Time frame: 0 and 12 weeks
Change from baseline at week 12: Plasma magnesium, calcium, iron, zinc, and copper (microgram/mL)
Oregon State University
Other
Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome
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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.
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