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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almonds | Active Comparator | Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks |
|
| Crackers | Placebo Comparator | Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond | Other | Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gut permeability and health: Serum endotoxin | Change from baseline at week 4: Marker of gut barrier function and health, serum endotoxin | 0 and 4 weeks |
| Gut permeability and health: Short chain fatty acids | Change from baseline at week 4: Markers of gut barrier function and health fecal short chain fatty acids profiles | 0 and 4 weeks |
| Gut permeability and health: Inflammatory biomarkers | Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase | 0 and 4 weeks |
| Biomarkers of inflammation | Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6) | 0 and 4 weeks |
| Oxidative stress status: malondialdehyde | Change from baseline at week 4: Plasma malondialdehyde | 0 and 4 weeks |
| Oxidative stress status: isoprostanes | Change from baseline at week 4: Urinary isoprostanes | 0 and 4 weeks |
| Cardiometabolic health | Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides | 0 and 12 weeks |
| Vitamin E status |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Change from baseline at week 4 and week 12: Systolic, and diastolic blood pressure | 0, 4 and 12 weeks |
| Weight | Change from baseline at week 4 and week 12: Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Beaver, PhD | Oregon State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon State University | Corvallis | Oregon | 97331 | United States |
Individual participant data will not be shared with other researchers without IRB approval.
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D064806 | Dysbiosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Crackers |
| Other |
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds) |
|
Change from baseline at week 4 and week 12: Plasma α-tocopherols
| 0, 4 and 12 weeks |
| Vitamin E status: Urinary catabolite | Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (α-CEHC) | 0, 4 and 12 weeks |
| 0, 4 and 12 weeks |
| BMI | Change from baseline at week 4 and week 12: BMI (weight and height will be combined to report BMI in kg/m^2) | 0, 4 and 12 weeks |
| Waist circumference | Change from baseline at week 4 and week 12: Waist circumference | 0, 4 and 12 weeks |
| Glycemic control: glucose | Change from baseline at week 12: Fasting blood glucose | 0 and 12 weeks |
| Glycemic control: Insulin | Change from baseline at week 12: Insulin | 0 and 12 weeks |
| Glycemic control: HOMA-IR | Change from baseline at week 12: HOMA-IR | 0 and 12 weeks |
| Other almond-based bioactives (polyphenol levels) | Change from baseline at week 12: Urinary metabolites of flavonoids like (+)-catechin, (-)-epicatechin and naringenin | 0 and 12 weeks |
| Mineral status | Change from baseline at week 12: Plasma magnesium, calcium, iron, zinc, and copper (microgram/mL) | 0 and 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |