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ACTIVE NOT RECRUITING

NCT05790564

Almonds to Improve Gut Health and Decrease Inflammation

Sponsor: Oregon State University

View on ClinicalTrials.gov

Summary

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.

Official title: Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome

Key Details

Gender

All

Age Range

35 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-11-17

Completion Date

2025-07

Last Updated

2024-10-03

Healthy Volunteers

Yes

Conditions

Metabolic Syndrome Dysbiosis Inflammation

Interventions

OTHER

Almond

Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks

OTHER

Crackers

Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)

Inclusion Criteria: * Age 35-60 years * 3 or more of the following: hypertension (systolic BP 130-179 mmHg or diastolic BP 85-119 mmHg); hyperglycemia (fasting glucose 100-599 mg/dL); central obesity \[waist circumference greater than 40.1 inches (M) or 34.6 inches (F); hypertriglyceridemia (150-499 mg/dL); low HDL \[lower than 40 mg/dL (M) or 50 mg/dL (F)\] * Willing to restrict consumption of nuts other than study nuts for 1 week prior to and throughout the study (13 weeks) * Willing to stop probiotic supplements one week prior to and during the study (13 weeks) * Willing to stop multivitamins and supplements containing vitamin E, magnesium, calcium, iron, zinc and copper one week prior to and during the study (13 weeks) * Willing to complete intake diaries during the study * Willing to maintain current eating patterns (no significant diet change during study) Exclusion Criteria: * Weekly consumption of almonds, hazelnuts, peanuts and sunflower seeds combined greater than 2 servings (about 2 oz) in the past 3 months * Nut, wheat, or gluten allergy/intolerance * Regular use of vitamin E supplements * Consume more than 2 alcoholic drinks daily * Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past 3 months * Pregnancy, breastfeeding, or planning to become pregnant before completing the study * Vigorous exercise greater than 7 hours/week * History of cardiovascular disease, liver disease or cancer * Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedures (e.g. cholecystectomy), disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis) or chronic diarrhea * Diagnosis of hemochromatosis * Chronic use (daily intake in past 30 days) of anti-inflammatory medication (steroid or NSAID) * Use of ezetimibe or orlistat * Use of oral antibiotic medication within the past month * Body Mass Index (BMI) \<25.0 or \>35.0 kg/m2 * Regular use of multivitamin supplements in the past 3 months * Physician prescribed use of probiotic, vitamin E, magnesium, calcium, iron, zinc or copper supplements

Locations (1)

Oregon State University

Corvallis, Oregon, United States