Almonds to Improve Gut Health and Decrease Inflammation

• Sponsor: Oregon State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05790564
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome; Dysbiosis; Inflammation	Other: Almond; Other: Crackers	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome
• Actual Study Start Date: Nov 17, 2022
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Almonds Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks	Other: Almond; Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Placebo Comparator: Crackers Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)	Other: Crackers; Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)

Outcome Measures

Primary Outcome Measures

1. Gut permeability and health: Serum endotoxin [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 [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 [0 and 4 weeks]

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

4. Biomarkers of inflammation [0 and 4 weeks]

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

5. Oxidative stress status: malondialdehyde [0 and 4 weeks]

   Change from baseline at week 4: Plasma malondialdehyde

6. Oxidative stress status: isoprostanes [0 and 4 weeks]

   Change from baseline at week 4: Urinary isoprostanes

7. Cardiometabolic health [0 and 12 weeks]

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

8. Vitamin E status [0, 4 and 12 weeks]

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

9. Vitamin E status: Urinary catabolite [0, 4 and 12 weeks]

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

Secondary Outcome Measures

1. Blood pressure [0, 4 and 12 weeks]

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

2. Weight [0, 4 and 12 weeks]

   Change from baseline at week 4 and week 12: Weight

3. BMI [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 [0, 4 and 12 weeks]

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

5. Glycemic control: glucose [0 and 12 weeks]

   Change from baseline at week 12: Fasting blood glucose

6. Glycemic control: Insulin [0 and 12 weeks]

   Change from baseline at week 12: Insulin

7. Glycemic control: HOMA-IR [0 and 12 weeks]

   Change from baseline at week 12: HOMA-IR

8. Other almond-based bioactives (polyphenol levels) [0 and 12 weeks]

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

9. Mineral status [0 and 12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon State University	Corvallis	Oregon	United States	97331

Sponsors and Collaborators

• Oregon State University

Investigators

• Principal Investigator: Laura Beaver, PhD, Oregon State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Beaver, Research Associate, Oregon State University
• ClinicalTrials.gov Identifier: NCT05790564
• Other Study ID Numbers: LPI-2022-1435
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Inflammation; Dysbiosis

Study Results

No Results Posted as of Mar 30, 2023