Clinical trial NCT05790564: Almonds to Improve Gut Health and Decrease Inflammation
Official title: Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Dysbiosis
Inflammation
Lead sponsor: Oregon State University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gut permeability and health: Serum endotoxin
timeFrame: 0 and 4 weeks
measure: Gut permeability and health: Short chain fatty acids
timeFrame: 0 and 4 weeks
measure: Gut permeability and health: Inflammatory biomarkers
timeFrame: 0 and 4 weeks
measure: Biomarkers of inflammation
timeFrame: 0 and 4 weeks
measure: Oxidative stress status: malondialdehyde
timeFrame: 0 and 4 weeks
measure: Oxidative stress status: isoprostanes
timeFrame: 0 and 4 weeks
measure: Cardiometabolic health
timeFrame: 0 and 12 weeks
measure: Vitamin E status
timeFrame: 0, 4 and 12 weeks
measure: Vitamin E status: Urinary catabolite
timeFrame: 0, 4 and 12 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 0, 4 and 12 weeks
measure: Weight
timeFrame: 0, 4 and 12 weeks
measure: BMI
timeFrame: 0, 4 and 12 weeks
measure: Waist circumference
timeFrame: 0, 4 and 12 weeks
measure: Glycemic control: glucose
timeFrame: 0 and 12 weeks
measure: Glycemic control: Insulin
timeFrame: 0 and 12 weeks
measure: Glycemic control: HOMA-IR
timeFrame: 0 and 12 weeks
measure: Other almond-based bioactives (polyphenol levels)
timeFrame: 0 and 12 weeks
measure: Mineral status
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Laura Beaver, PhD
role: PRINCIPAL_INVESTIGATOR
References: