Effect of a Nutritional Supplement on Gut Microbiota in Adults

NCT06611215 | Not Yet Recruiting DMC

• 1 other identifier: AFCRO-184
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers/ Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.

Conditions

Changes in Gut Microbiota with Prebiotic Supplementation; Quality of Life

Keywords

microbiome; dietary supplement; prebiotic

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of eight weeks consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at the end of 8 week intervention

  Change in gut microbiota composition defined by percentage abundances of microbes (determined by shotgun sequencing of fecal samples) from baseline to end of intervention (Day 56) in the two prebiotic supplements compared to the corresponding Placebo

  From baseline to Week 8

Secondary Outcomes (3)

• To evaluate the effect of consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at Week 4

  From baseline to week 4

• To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 4

  From baseline to week 4

• To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 8

  From baseline to Week 8

Study Arms (4)

Prebiotic 1

EXPERIMENTAL

Dietary Supplement: Treatment

Placebo 1

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Prebiotic 2

EXPERIMENTAL

Dietary Supplement: Treatment

Placebo 2

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Treatment DIETARY_SUPPLEMENT

Prebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning

Prebiotic 1

Placebo DIETARY_SUPPLEMENT

Placebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning

Placebo 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be between 18-60 years inclusive.
• BMI between 18.5 - 29.9kg/m2
• Is in general good health, as determined by the investigator.
• Consume less than 18g fiber per day.
• Maintain current dietary habits and physical activity levels.
• Willing to consume the Study Product for the duration of the study.

You may not qualify if:

• Participants will be excluded from the study if they meet any of the following criteria:
• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• 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.
• Participants who are on anxiolytics, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication at the time of screening.
• Participants with a current or history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
• 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.
• 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:
• Immunocompromised individuals (HIV/AIDS, chemo/radiation)
• 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).
• 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:
• Anti-infectives (including antibiotics/antifungals. HIV prophylaxis is acceptable) within the 90 days prior visit 1 and for the duration of study.
• Steroids (inhaled, oral, or injected. Topical PRN use is acceptable) within the 28 days prior to visit 1 and for duration of study.

Sponsors & Collaborators

• Pharmavite LLC: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials, 142 E Ontario St

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.

  PMID: 28611480 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Kevin O'Regan, Operations Manager

CONTACT

312-535-9440; koregan@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding of both study team and participants will be ensured by only providing access to the randomization list to the science and quality team. The relationship between the randomization number and the group assignment will be unknown to the participants, clinical study team, and the Sponsor, i.e. the study will be double-blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 4 arm double blind randomized placebo controlled trial for 2 prebiotic supplements with respective placebos as parallel groups - 2 treatments and 2 placebos.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 24, 2024
• Study Start: September 23, 2024
• Primary Completion: April 7, 2025
• Study Completion: June 2, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)