Almonds to Improve Gut Health and Decrease Inflammation

NCT05790564 | Active Not Recruiting

• 1 other identifier: LPI-2022-1435
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Dysbiosis; Inflammation

Outcome Measures

Primary Outcomes (9)

• 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

  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

Secondary Outcomes (9)

• Blood pressure

  0, 4 and 12 weeks

• Weight

  0, 4 and 12 weeks

• BMI

  0, 4 and 12 weeks

• Waist circumference

  0, 4 and 12 weeks

• Glycemic control: glucose

  0 and 12 weeks

Study Arms (2)

Almonds

ACTIVE COMPARATOR

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

Other: Almond

Crackers

PLACEBO COMPARATOR

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

Other: Crackers

Interventions

Almond OTHER

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

Almonds

Crackers OTHER

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

Crackers

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-60 years
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon State University: lead

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Dysbiosis; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Beaver, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 30, 2023
• Study Start: November 17, 2022
• Primary Completion: October 1, 2024
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)