Standard Process Heart and Gut Health Study

February 6, 2025 updated by: Standard Process Inc.

Effects of a Whole Food Based Nutritional Formulation on Trimethylamine N-oxide and Cardiometabolic Endpoints in Healthy Adults.

Standard Process Heart and Gut Health Study

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This prospective pilot clinical study will screen 45 healthy participants regularly consuming omnivorous diet (full fat dairy, red meat, eggs, fish) and have elevated serum Trimethyl amine N-oxide (TMAO) levels. Trimethylamine N-oxide (TMAO) is a gut microbiota derived dietary metabolite which is emerging as a significant and independent predictor of cardiovascular disease (CVD) risk mainly through inflammation and oxidative stress pathways. Long term consumption of animal products elevates TMAO levels due to its abundance of TMAO precursors: choline and L-carnitine. As diet plays a key role in altering the microbial composition and subsequent TMAO levels, it is important to investigate if whole food based nutritional formulations can provide the necessary support required to manage TMAO levels and hence, positively impact cardiometabolic endpoints. Towards this end both B and D vitamins have been shown to influence the levels of circulating TMAO while maintaining a healthy gut microenvironment.

This pilot study aims to explore the modulation of TMAO response in healthy adults after supplementation with a whole food matrix-based B vitamins formulation alone, and in combination with vitamin D. The assessments will be compared to the diet only control group.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • Standard Process Nutrition Innovation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy participants (both male and female) aged 25-80 years with omnivorous diet (regular consumption of eggs, red meat, dairy)
  • No pre or probiotic consumption during study, no antibiotics during study
  • Moderate to high serum levels of TMAO (more than or equal to 4 uM) determined by a standard blood test
  • If the participant is on antibiotics, they should finish their medication and wait one month before testing for TMAO as a screening criterion
  • Normal blood pressure, non-smokers
  • Normal cholesterol
  • Participants can communicate and follow instructions
  • Participants voluntarily signed and dated an informed consent (ICF), reviewed by an Institutional Review Board (IRB), and provided authorization prior to any participation in the study
  • Participants who are willing to take nutritional supplements and have no known food allergies

Exclusion Criteria:

  • Vegan and vegetarian participants
  • Participants on medically prescribed diet
  • Participants not willing to stop consumption of fermented products (plain yogurt, kefir, kombucha, water kefir, miso, pickled vegetables, and sauerkraut) 2 weeks prior to the study start date and during the study timeline as this will interfere with gut microbiome related outcome assessment
  • Participants not willing to stop consuming polyphenols- green tea, cocoa, flaxseed, berries, and energy drinks
  • Participants who are currently or have participated in other interventional clinical trials in the last 4 weeks
  • Participants on certain supplements like GI health related (Probiotics, prebiotics, and/or antimicrobial botanicals), vitamin C, Choline, lecithin or L-carnitine, fish oil/krill oil containing supplements who don't wish to stop supplementation prior to 2 weeks of study start date
  • Participants who have any confirmed or suspected infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection), malignancy, or any other clinically significant medical condition, which in the investigators' opinion, makes him or her not suitable for inclusion in the study*
  • Participants who have pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device
  • Participants who have confirmed or suspected pregnancy (self-reported)
  • Participant waiting for a heart transplant
  • Participants currently hospitalized for acute myocardial infarction
  • Participants with a planned revascularization within 30 days of screening
  • Participants must not have any allergies to supplement ingredients (see list)
  • Participants who have initiated the use of prescription medications (defined as a medication that can be prescribed only by a properly authorized/licensed clinician), and not authorized non-prescription medications (over-the-counter medications), and other nutritional supplements
  • Participants who do not comply with all study requirements (including clinical visits)
  • Participants with high cholesterol or on lipid lowering medications like statins
  • Participants on following medication: NSAIDS, Steroids, Prednisone, Acid Reflux/GERD medicines: Tagamet, Zantac, Pepcid, Prilosec, Prevacid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Diet Only Group
Diet only: guided diet
Experimental: Combination Group
Combination of whole food-based B and D vitamins
Dietary supplement: Whole food-based B and D vitamins
Looking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity
Experimental: B Only Group
Whole food-based B vitamins
Dietary supplement: Whole food-based B and D vitamins
Looking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary
Time Frame: 8 weeks
One outcome is to determine if a combination of whole food-based B-vitamins can modulate gut diversity and TMAO response
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary
Time Frame: 8 weeks
Another outcome is to explore the beneficial interplay between B and D vitamin supplementation in reducing TMAO levels through modulation of gut microbiome.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Standard Process Inc.

Investigators

  • Principal Investigator: Chinmayee Panda, PhD, Standard Process Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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