Effect of a Nutritional Supplement on Gut Microbiota in Adults

Launched by PHARMAVITE LLC · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a nutritional supplement, specifically a combination of two prebiotics, on gut health and overall quality of life in adults. Prebiotics are dietary substances that help beneficial bacteria in our gut grow and thrive. By taking these supplements, researchers hope to understand how they can positively affect gut microbiota, which is the community of microorganisms living in our intestines that play a crucial role in our health.

To participate in this study, you need to be between 18 and 60 years old, generally healthy, and consume less than 18 grams of fiber each day. You'll also need to be willing to maintain your usual diet and activity level during the study and take the supplement as directed. There are some exclusions, such as being pregnant or breastfeeding, using certain medications, or having specific health conditions. If you qualify and decide to join, you can expect to take the study product for a certain duration and help researchers learn more about improving gut health and quality of life for people like you.

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.