Standard Process Heart and Gut Health Study

NCT05795946 | Terminated

• 1 other identifier: SP0012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Standard Process Heart and Gut Health Study

Conditions

Nutrition, Healthy

Keywords

Heart health; B Vitamins; D Vitamins; TMAO; Quality of Life; Healthy Heart

Outcome Measures

Primary Outcomes (1)

• Primary

  One outcome is to determine if a combination of whole food-based B-vitamins can modulate gut diversity and TMAO response

  8 weeks

Secondary Outcomes (1)

• Secondary

  8 weeks

Study Arms (3)

Diet Only Group

NO INTERVENTION

Diet only: guided diet

Combination Group

EXPERIMENTAL

Combination of whole food-based B and D vitamins

Dietary Supplement: Whole food-based B and D vitamins

B Only Group

EXPERIMENTAL

Whole food-based B vitamins

Dietary Supplement: Whole food-based B and D vitamins

Interventions

Whole food-based B and D vitamins DIETARY_SUPPLEMENT

Looking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity

B Only Group; Combination Group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Standard Process Inc.: lead

Study Sites (1)

Standard Process Nutrition Innovation Center

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (41)

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Study Officials

• Chinmayee Panda, PhD

  Standard Process Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The labels for the vitamins will only have the participant ID on them
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: April 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)