Almonds to Improve Gut Health and Decrease Inflammation (NCT05790564) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Almonds to Improve Gut Health and Decrease Inflammation
United States80 participantsStarted 2022-11-17
Plain-language 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.
Who can participate
Age range35 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. ga…
What they're measuring
1
Gut permeability and health: Serum endotoxin
Timeframe: 0 and 4 weeks
2
Gut permeability and health: Short chain fatty acids
Timeframe: 0 and 4 weeks
3
Gut permeability and health: Inflammatory biomarkers