Clinical trial NCT05795946: Standard Process Heart and Gut Health Study
Official title: Effects of a Whole Food Based Nutritional Formulation on Trimethylamine N-oxide and Cardiometabolic Endpoints in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nutrition, Healthy
Keywords: Heart health
B Vitamins
D Vitamins
TMAO
Quality of Life
Healthy Heart
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups: 1 for B vitamins only, 1 with B vitamins in addition of D vitamins, and one is diet only.

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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Standard Process Heart and Gut Health Study

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary
timeFrame: 8 weeks
Secondary outcomes:
measure: Secondary
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Standard Process Nutrition Innovation Center
state: North Carolina
Study officials:
affiliation: Standard Process Inc.
name: Chinmayee Panda, PhD
role: PRINCIPAL_INVESTIGATOR
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