Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT07145658
Eligibility Criteria:
Inclusion Criteria:
1. Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
2. Participant has no significant medical diagnosis (health individuals)
3. Participant takes no regular prescription medication
4. Participant is not undertaking any restrictive diet (e.g. Carnivore, Low FODMAP)
5. Participant agrees to adhere to guidance on fortified food intake for the duration of the study
6. Participant is a male or non-pregnant female and is 18-70 years of age
7. If WOCBP participant is willing to adhere to one of the following methods of contraception i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) iv) Hysterectomy v) Vasectomised partner vi) Sexual abstinence (if it is in line with your preferred and usual lifestyle).
8. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
9. Participant has capacity to understand written English.
10. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
11. Participant agrees to follow all pre-test preparation before L/M-HMBT testing.
Exclusion Criteria:
1. Participant has consumed nutritional supplement in the past 3 months
2. Diagnosis of any current medical condition, except visual impairment and other conditions at the discretion of the investigator
3. Participated in a trial of an investigational medical product or medical device in the last 28 days.
4. Females who report to be pregnant or lactating
5. Prior abdominal surgery
6. Unwilling to maintain a stable diet for the duration of the trial.
7. Unable to comply with limiting fortified food intake to \<5 portions per week for the duration of the study
8. Being in the opinion of the investigator unsuitable
9. Insufficient knowledge of English to complete the daily bowel diary and food diary.
10. Hypersensitivity to any component of the supplement
11. Hypersensitivity or known allergy to lactulose or mannitol.
12. Consumption of oral antibiotics in the last 4 weeks.
13. NSAIDs for 2 weeks prior to and during the entire 90 day study period. Participant should not be a chronic NSAID user (\>1 day/week).
14. Gastrointestinal infection in the past 4 weeks.
15. IV vitamin/mineral therapy in the past 12 weeks
16. Use of medical devices for the purpose of cognitive enhancement, such as neural stimulation, in the 2 weeks prior or during the study period
17. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07145658
Study Brief:
Protocol Section:
NCT07145658