Almonds to Improve Gut Health and Decrease Inflammation

NCT ID: NCT05790564

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2025-07-31

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.

Conditions

Metabolic Syndrome; Dysbiosis; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Almonds

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

Group Type: ACTIVE_COMPARATOR

Almond

Intervention Type: OTHER

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

Crackers

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

Group Type: PLACEBO_COMPARATOR

Crackers

Intervention Type: OTHER

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

Interventions

Almond

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

Intervention Type: OTHER

Crackers

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon State University

OTHER

Sponsor Role: lead

Responsible Party

Laura Beaver

Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Beaver, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Oregon State University

Corvallis, Oregon, United States

Countries

United States

Other Identifiers

LPI-2022-1435

Identifier Type: -

Identifier Source: org_study_id