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Active, Not Recruiting

NCT Number: NCT05790564

Almonds to Improve Gut Health and Decrease Inflammation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Almond

Other

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

Crackers

Other

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

Primary outcomes

  1. Gut permeability and health: Serum endotoxin

    Time frame: 0 and 4 weeks

    Change from baseline at week 4: Marker of gut barrier function and health, serum endotoxin

  2. Gut permeability and health: Short chain fatty acids

    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

  3. Gut permeability and health: Inflammatory biomarkers

    Time frame: 0 and 4 weeks

    Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase

  4. Biomarkers of inflammation

    Time frame: 0 and 4 weeks

    Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6)

  5. Oxidative stress status: malondialdehyde

    Time frame: 0 and 4 weeks

    Change from baseline at week 4: Plasma malondialdehyde

  6. Oxidative stress status: isoprostanes

    Time frame: 0 and 4 weeks

    Change from baseline at week 4: Urinary isoprostanes

  7. Cardiometabolic health

    Time frame: 0 and 12 weeks

    Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides

  8. Vitamin E status

    Time frame: 0, 4 and 12 weeks

    Change from baseline at week 4 and week 12: Plasma α-tocopherols

  9. Vitamin E status: Urinary catabolite

    Time frame: 0, 4 and 12 weeks

    Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (α-CEHC)

Secondary outcomes

  1. Blood pressure

    Time frame: 0, 4 and 12 weeks

    Change from baseline at week 4 and week 12: Systolic, and diastolic blood pressure

  2. Weight

    Time frame: 0, 4 and 12 weeks

    Change from baseline at week 4 and week 12: Weight

  3. BMI

    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)

  4. Waist circumference

    Time frame: 0, 4 and 12 weeks

    Change from baseline at week 4 and week 12: Waist circumference

  5. Glycemic control: glucose

    Time frame: 0 and 12 weeks

    Change from baseline at week 12: Fasting blood glucose

  6. Glycemic control: Insulin

    Time frame: 0 and 12 weeks

    Change from baseline at week 12: Insulin

  7. Glycemic control: HOMA-IR

    Time frame: 0 and 12 weeks

    Change from baseline at week 12: HOMA-IR

  8. Other almond-based bioactives (polyphenol levels)

    Time frame: 0 and 12 weeks

    Change from baseline at week 12: Urinary metabolites of flavonoids like (+)-catechin, (-)-epicatechin and naringenin

  9. Mineral status

    Time frame: 0 and 12 weeks

    Change from baseline at week 12: Plasma magnesium, calcium, iron, zinc, and copper (microgram/mL)

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Registry information

Official study title

Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Mar 30, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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