Oral Probiotics on the Shift in Gut Microbiome and Skin Carotenoid Levels

Sponsor
Integrative Skin Science and Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04841694
Collaborator
Microbiome labs (Other)
25
1
1
9
2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to determine how probiotics affects circulating carotenoid levels.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
N/A

Detailed Description

Certain probiotic strains are rich in the production of carotenoids. This study will evaluate if probiotic supplementation with a carotenoid rich strain will augment circulating carotenoids.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Prospective Randomized Double-Blind Placebo Controlled Study of Oral Probiotics on the Shift of Gut Microbiome and Skin Carotenoid Levels
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic

Participants will be taking a probiotic supplement that they will be taking by mouth once per day

Dietary Supplement: Probiotic
Bacillus indicus

Outcome Measures

Primary Outcome Measures

  1. Carotenoid Levels [5 weeks]

    Change in skin carotenoid level and blood carotenoid level with supplementation

Secondary Outcome Measures

  1. Gut Microbiome Changes [Week 5]

    Shift in gut microbiome diversity

  2. Assessment of GI related gas and constipation [Week 5]

    self assessment using digestive health questionnaire

  3. Assessment of GI related gas and constipation [Week 6]

    self assessment using digestive health questionnaire

  4. Shift in facial redness- image based [Week 5]

    BTBP Clarity Mini 3D camera

  5. Shift in facial redness- image based [Week 6]

    BTBP Clarity Mini 3D camera

  6. Shift in facial pigmentation - image based [Week 5]

    BTBP Clarity Mini 3D camera

  7. Shift in facial pigmentation - image based [Week 6]

    BTBP Clarity Mini 3D camera

  8. Protection against blue light exposure induced change in skin color [Weeks 5]

    Change in skin color measured by a skin colorimeter

  9. Protection against blue light exposure induced change in skin color [Weeks 6]

    Change in skin color measured by a skin colorimeter

  10. Carotenoid Levels [5 weeks]

    Change in skin carotenoid level and blood carotenoid level with supplementation

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Subjects aged 40+

  • Must be willing to comply with all protocol requirements

  • Must be willing to have flash photo facial images taken with the imaging systems

  • Fitzpatrick skin type II, III, or IV

Exclusion Criteria:
  • Any systemic or antibiotics (injected or oral) within 6 months of starting study

  • Any topical antibiotic or Vitamin A within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or vitamin A ingredient.

  • Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator.

  • Limit total fruit and vegetable intake to 2.5 servings (1 serving=1 cup) per day of high carotenoid foods. High carotenoid foods include spinach, summer squash, carrots, citrus fruits, celery, kale, tomatoes, and cantaloupe

  • Subjects must have no history of malignancy or cancer (excluding skin cancer unless there is a history of metastasis) or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)

  • Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results

  • Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.

  • Is participating in a concurrent intervention based clinical research study

  • Those with BMI higher than 35 kg/m²

  • Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.

  • Is participating in or has participated in a intervention based facial study at this or any other facility in the past 2 weeks. Participation in survey-based studies are approved at the discretion of the investigator.

  • Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator

  • Refusal to shave or remove facial hair that may interfere with image collection and assessment.

  • Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.

  • Known allergy or irritation to the supplement utilized in the study

  • Persons unwilling to avoid sun exposure to the inner forearm

  • Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco

  • Cutaneous photosensitivity at wavelengths of 400-450 nm

  • Porphyria or known allergies to porphyrins

  • Prisoners

  • Adults unable to consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrative Skin Science and Research Sacramento California United States 95815

Sponsors and Collaborators

  • Integrative Skin Science and Research
  • Microbiome labs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raja Sivamani, Principal Investigator, Integrative Skin Science and Research
ClinicalTrials.gov Identifier:
NCT04841694
Other Study ID Numbers:
  • PROB-CAROT
First Posted:
Apr 12, 2021
Last Update Posted:
May 3, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raja Sivamani, Principal Investigator, Integrative Skin Science and Research

Study Results

No Results Posted as of May 3, 2021