Almonds to Improve Gut Health and Decrease Inflammation

Metabolic Syndrome Clinical Trial

Official title:

Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790564
• Other study ID #: LPI-2022-1435
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: Oregon State University
• Contact: Laura Beaver, PhD
• Phone: 541-737-5049
• Email: laura.beaver[@]oregonstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Inflammation
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Almond
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)

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Gut permeability and health: Inflammatory biomarkers	Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase	0 and 4 weeks
Primary	Biomarkers of inflammation	Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6)	0 and 4 weeks
Primary	Oxidative stress status: malondialdehyde	Change from baseline at week 4: Plasma malondialdehyde	0 and 4 weeks
Primary	Oxidative stress status: isoprostanes	Change from baseline at week 4: Urinary isoprostanes	0 and 4 weeks
Primary	Cardiometabolic health	Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides	0 and 12 weeks
Primary	Vitamin E status	Change from baseline at week 4 and week 12: Plasma a-tocopherols	0, 4 and 12 weeks
Primary	Vitamin E status: Urinary catabolite	Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (a-CEHC)	0, 4 and 12 weeks
Secondary	Blood pressure	Change from baseline at week 4 and week 12: Systolic, and diastolic blood pressure	0, 4 and 12 weeks
Secondary	Weight	Change from baseline at week 4 and week 12: Weight	0, 4 and 12 weeks
Secondary	BMI	Change from baseline at week 4 and week 12: BMI (weight and height will be combined to report BMI in kg/m^2)	0, 4 and 12 weeks
Secondary	Waist circumference	Change from baseline at week 4 and week 12: Waist circumference	0, 4 and 12 weeks
Secondary	Glycemic control: glucose	Change from baseline at week 12: Fasting blood glucose	0 and 12 weeks
Secondary	Glycemic control: Insulin	Change from baseline at week 12: Insulin	0 and 12 weeks
Secondary	Glycemic control: HOMA-IR	Change from baseline at week 12: HOMA-IR	0 and 12 weeks
Secondary	Other almond-based bioactives (polyphenol levels)	Change from baseline at week 12: Urinary metabolites of flavonoids like (+)-catechin, (-)-epicatechin and naringenin	0 and 12 weeks
Secondary	Mineral status	Change from baseline at week 12: Plasma magnesium, calcium, iron, zinc, and copper (microgram/mL)	0 and 12 weeks