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Vitamin
Combination Group for Healthy Nutrition
N/A
Recruiting
Led By Chinmayee Panda, PhD
Research Sponsored by Standard Process Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial tested the effects of nutrition on heart & digestive health. Results showed promise in improving both.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary
Secondary outcome measures
Secondary
Side effects data
From 2015 Phase 3 trial • 486 Patients • NCT020144677%
Arthralgia
5%
Blood cholesterol increased
1%
Any event
1%
Femoral neck fracture
1%
Bone density decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab 60mg
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Combination GroupExperimental Treatment1 Intervention
Combination of whole food-based B and D vitamins
Group II: B Only GroupExperimental Treatment1 Intervention
Whole food-based B vitamins
Group III: Diet Only GroupActive Control1 Intervention
Diet only: guided diet
Find a Location
Who is running the clinical trial?
Standard Process Inc.Lead Sponsor
12 Previous Clinical Trials
561 Total Patients Enrolled
Chinmayee Panda, PhDPrincipal InvestigatorStandard Process Inc.
2 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Participants signed and dated an ICF that was reviewed by an IRB, granting permission to participate in the study.For participants on antibiotics, completion of their medication and a 1-month waiting period is required prior to testing for TMAO as a screening measure.You are a male or female aged between 25-80 years and have an omnivorous diet, including regular consumption of eggs, red meat, and dairy products.You cannot eat fermented foods (like yogurt, pickles, and sauerkraut) for two weeks before and during the study because it will affect the study's measurement of your gut bacteria.You are not willing to stop consuming certain foods and drinks like green tea, cocoa, flaxseed, berries, and energy drinks.You cannot have any allergies to the ingredients listed in the supplement.You abstained from pre and probiotic consumption, as well as antibiotics during the study.You are willing to ingest nutritional supplements and have no known dietary sensitivities.Your cholesterol levels are within normal range.You have a normal blood pressure without any history of smoking.Your TMAO levels are at least 4 uM, as established by a standard blood analysis.You are verbally adept and can comply with instructions.People who follow a vegan or vegetarian diet.You are waiting for a heart transplant.You are taking certain supplements like probiotics, vitamins, or fish oil/krill oil, and you do not want to stop taking them for at least two weeks before the study starts.You have a confirmed or suspected infectious disease (like tuberculosis, Hepatitis B or C, HIV), cancer or other serious medical condition that could prevent you from participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Group
- Group 2: Diet Only Group
- Group 3: B Only Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Nutrition Patient Testimony for trial: Trial Name: NCT05795946 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial open to individuals younger than 30 years of age?
"As specified by the enrollment criteria, individuals between 25 and 80 years of age are eligible to be part of this clinical trial."
Answered by AI
How many persons are participating in the experimental protocol?
"Affirmative. Clinicaltrials.gov's information indicates that this medical trial is presently hunting for participants, which was first posted on April 15th 2023 and recently refreshed on March 21st 2023. 45 enrollees are sought after from one facility."
Answered by AI
Does this research endeavor require additional participants at present?
"As per clinicaltrials.gov, this trial is actively seeking out patients and was first posted on April 15th 2023 with the latest edit made on March 21st of the same year."
Answered by AI
What demographic of participants is most advantageous to include in this clinical trial?
"This research is accepting around 45 candidates that are between 25 and 80 years of age, provided they have a balanced diet."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Docs Outside the Box
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
It came up as a healthy trial when I googled.
PatientReceived 1 prior treatment
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