Search / Trial NCT06611215

Effect of a Nutritional Supplement on Gut Microbiota in Adults

Launched by PHARMAVITE LLC · Sep 20, 2024

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Trial Information

Current as of December 21, 2024

Not yet recruiting

Keywords

Microbiome Dietary Supplement Prebiotic

ClinConnect Summary

This is a 4 arm randomized, placebo-controlled, double-blind, parallel study, which will be conducted remotely and will include 4 visits over 10 week period - a screening visit (Visit 1; week -2), a 2-week run-in period followed by baseline determination or baseline visit (Visit 2; day 0), and two test visits (Visits 3 and 4 at days 28, and 56 respectively).

SCREENING Visit 1 - Week -2

At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:

* Participants will receive oral and written information about the study and be allowe...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • To be eligible for inclusion, the Participant must fulfil all the following criteria:
  • • 1. Be able to give written informed consent.
  • • 2. Be between 18-60 years inclusive.
  • • 3. BMI between 18.5 - 29.9kg/m2
  • • 4. Is in general good health, as determined by the investigator.
  • • 5. Consume less than 18g fiber per day.
  • • 6. Maintain current dietary habits and physical activity levels.
  • • 7. Willing to consume the Study Product for the duration of the study.
  • Exclusion Criteria:
  • Participants will be excluded from the study if they meet any of the following criteria:
  • • 1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
  • • 2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: a. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
  • • b. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
  • • c. Sexual partner(s) is/are exclusively female. d. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
  • • e. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
  • • 3. Participants who are on anxiolytics, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication at the time of screening.
  • • 4. Participants with a current or history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
  • • 5. Change in medications or supplements, or major dietary changes within 90 days of visit 1, or planning to do so during the study. This includes planning to start any new medications, herbals, or supplements.
  • 6. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history including but not limited to:
  • • 1. Immunocompromised individuals (HIV/AIDS, chemo/radiation)
  • • 2. Significant psychiatric disease (bipolar, schizophrenia, severe depression. Mild to Moderate depression stable on low dose medications \>3 months may be considered eligible in the opinion of the investigator).
  • 7. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications including but not limited to:
  • • 1. Anti-infectives (including antibiotics/antifungals. HIV prophylaxis is acceptable) within the 90 days prior visit 1 and for the duration of study.
  • • 2. Steroids (inhaled, oral, or injected. Topical PRN use is acceptable) within the 28 days prior to visit 1 and for duration of study.
  • • 3. Antipsychotic, Anxiolytics, hypnotics.
  • • 4. Anticonvulsants.
  • • 5. Prescribed sleeping medications
  • • 6. Anti-rejection Medications
  • • 7. Opioid pain relievers
  • 8. Current or recent use of prohibited foods and nutritional or non-nutritional supplements, including:
  • • a. Probiotics, Prebiotics, Post biotics and other fermented foods within the 28 days prior to visit 1. (Yogurt, kefir, kombucha) and for the duration of the study.
  • • 9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
  • • 10. Participants may not be receiving treatment involving experimental drugs/supplements. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

About Pharmavite Llc

Pharmavite LLC is a leading nutritional supplement company dedicated to enhancing health and well-being through innovative and scientifically-backed products. As a subsidiary of the esteemed Nature's Way, Pharmavite specializes in the development and manufacturing of high-quality vitamins, minerals, and herbal supplements. The company is committed to rigorous quality standards and regulatory compliance, ensuring that all products meet the highest levels of safety and efficacy. With a focus on research and development, Pharmavite actively engages in clinical trials and partnerships to advance nutritional science and provide consumers with reliable, effective health solutions.

Locations

Chicago, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0