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Metabolic SyndromeNCT05790564

Almonds to Improve Gut Health and Decrease Inflammation

A study testing Almond and Crackers in people with Metabolic Syndrome and Dysbiosis, run by Oregon State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome, Dysbiosis, Inflammation
What is being tested?
Almond and Crackers
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
17 Nov 2022to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon State University

    Corvallis, Oregon, 97331

Other trials in United States

About this study

Official title: Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome

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.

Read the 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.

Being tested
Almond, Crackers
Medical subject headings
Metabolic Syndrome, Dysbiosis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlmondOther

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

  • CrackersOther

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

Study groups in NCT05790564
Study groupRoleWhat they receive
AlmondsActive comparatorDaily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Receives: Other: Almond
CrackersPlacebo comparatorDaily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
Receives: Other: Crackers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut permeability and health: Serum endotoxin

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

    Measured: 0 and 4 weeks

  2. 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

    Measured: 0 and 4 weeks

  3. Gut permeability and health: Inflammatory biomarkers

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

    Measured: 0 and 4 weeks

  4. Biomarkers of inflammation

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

    Measured: 0 and 4 weeks

  5. Oxidative stress status: malondialdehyde

    Change from baseline at week 4: Plasma malondialdehyde

    Measured: 0 and 4 weeks

  6. Oxidative stress status: isoprostanes

    Change from baseline at week 4: Urinary isoprostanes

    Measured: 0 and 4 weeks

  7. Cardiometabolic health

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

    Measured: 0 and 12 weeks

  8. Vitamin E status

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

    Measured: 0, 4 and 12 weeks

  9. Vitamin E status: Urinary catabolite

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

    Measured: 0, 4 and 12 weeks

Secondary outcomes (9)

  1. Blood pressure

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

    Measured: 0, 4 and 12 weeks

  2. Weight

    Change from baseline at week 4 and week 12: Weight

    Measured: 0, 4 and 12 weeks

  3. BMI

    Change from baseline at week 4 and week 12: BMI (weight and height will be combined to report BMI in kg/m^2)

    Measured: 0, 4 and 12 weeks

  4. Waist circumference

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

    Measured: 0, 4 and 12 weeks

  5. Glycemic control: glucose

    Change from baseline at week 12: Fasting blood glucose

    Measured: 0 and 12 weeks

  6. Glycemic control: Insulin

    Change from baseline at week 12: Insulin

    Measured: 0 and 12 weeks

  7. Glycemic control: HOMA-IR

    Change from baseline at week 12: HOMA-IR

    Measured: 0 and 12 weeks

  8. Other almond-based bioactives (polyphenol levels)

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

    Measured: 0 and 12 weeks

  9. Mineral status

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

    Measured: 0 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start17 Nov 2022
  3. Primary completion1 Oct 2024
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05790564
Sponsor's protocol ID
LPI-2022-1435
Status last verified
Apr 2026
First submitted
3 Mar 2023
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers without IRB approval.

Questions about this trial

What is this clinical trial studying?

A study testing Almond and Crackers in people with Metabolic Syndrome and Dysbiosis, run by Oregon State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut permeability and health: Serum endotoxin (time frame: 0 and 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05790564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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