Eligibility |
Inclusion Criteria:
1. Voluntary, written, informed consent to participate in the study
2. Agreement to comply with the protocol and study restrictions
3. Healthy females and males of age 18 to 50 years (inclusive)
4. Participants recognize themselves as white or American Indian or Alaska Native or
Asian or Black / African American or Native Hawaiian or Other Pacific Islander or
Hispanic and Latinos or Multiracial. Participant numbers are limited to a maximum of
10 (males and females) from each group.
5. Participants consume > 4 portions of fruits and vegetables per day and who agree to
maintain their usual dietary habits, their usual exercise habits, hygienic habits and
their lifestyle in general throughout the trial period
6. Females of child-bearing potential who agree to use medically approved methods of
birth control
7. Ability of the participant (in the investigator's opinion) to comprehend the full
nature and purpose of the study
8. BMI between 18.5-25.
Exclusion Criteria:
1. Participation in a clinical trial with an investigational product or drug within 60
days prior to screening.
2. Likeliness to be noncompliant with the protocol, or to be unsuitable to the study as
judged by the study staff for any reason.
3. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling).
4. History of diagnosed eating disorder (anorexia, bulimia).
5. Consumption of fast food > 3 times/week. Where fast food is referred to high
carbohydrate and fat rich diet.
6. History of drug (> 2 times per week) during last 2 years or alcohol abuse (> 08
portions per week for females and 15 portions/week for males, or >3 portions/day)
during the last 3 months.
7. Pregnant or breastfeeding women; women planning to become pregnant during the study.
8. Clinically significant underlying systemic illness that may preclude the participant's
ability to complete the trial or that may affect the study outcomes (e.g. bowel
cancer, prostate cancer, terminal illness, coronary heart disease/cardiovascular
disease or artificial heart valve, HIV, STD, AIDS, hepatitis and autoimmune diseases
e.g. MS-disease, thyroid diseases)
9. Use of prescription anti-obesity drugs, temporary or irregular medication for
diabetes, dyslipidemia or hypertension, non-steroidal anti-inflammatory drugs,
corticosteroids, or equivalent immunomodulatory drugs, immunosuppression or ongoing
therapy causing immunosuppression and ongoing or recent (last 3 months) antibiotic
treatment.
10. Diagnosed or suspected organic gastrointestinal disease (e.g. colitis, Crohn's
disease, celiac disease, recurrent diverticulitis) or non-organic disease (e.g. IBS),
or functional constipation, during the last year.
11. Colonoscopy within 3 months before screening
12. Colon cleansing within 3 months before screening.
13. Gastrointestinal infection within 6 months before screening
14. Active or recent (last 3 months) participation in a weight loss program including
weight change (increase or loss) of 3 kg during the past three months. History of
bariatric surgery.
15. History of gingivitis, periodontitis, or any oral disease during last 6 months.
16. History of smoking or tobacco use in any form and/or electronic cigarette during the
last 6 months.
17. History of skin diseases (e.g. atopic dermatitis (Eczema), hives, dermatitis,
psoriasis, or rashes) during the last 6 months.
18. History of SARS CoV-2 infection.
19. Participants under administrative or legal supervision.
20. Other reasons that, in the opinion of the Investigator, make the participant
unsuitable for enrollment
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