| Eligibility |
Inclusion Criteria:
1. Male or female, 18-55 years of age, inclusive at Visit 1 (Day -11).
2. BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -11).
3. Have normal bowel movement habit (<3 bowel movements/d to >2 bowel movements/week)
based on the BHD-BSS collected at Visit 2 (Day -4).
4. Consumes fiber at an amount no more than the average American diet [based on
consumption of high-fiber containing plant-based foods (e.g., fruits, vegetables,
legumes, pulses, nuts, and products labeled as good or excellent sources of fiber)].
5. Smokes 10 cigarettes or less in a day and has no plan to change nicotine habits during
the study period.
6. Non-user or former users (cessation =12 mo) of any marijuana or hemp products and has
no plans to use marijuana or hemp products during the study period.
7. Willing to maintain habitual dietary, lifestyle, and physical activity (with
exceptions per study instructions) throughout the trial and willing to adhere to
dietary, lifestyle, and physical activity requirements of the study.
8. Willing to limit alcohol consumption to =3 standard drinks/d and =7 standard
drinks/week throughout the trial.
9. Willing to refrain from exclusionary medications, supplements, and products throughout
the study.
10. No health conditions that would prevent him/her from fulfilling the study requirements
as judged by the Clinical Investigator on the basis of medical history and routine
laboratory test results.
11. Understands the study procedures and signs forms providing informed consent to
participate in the study and authorizes the release of relevant protected health
information to the Clinical Investigator.
Exclusion Criteria:
1. Moderate or severe GI symptoms or 3-d total score of >2 for any individual GI symptom
based on the baseline GITQ collected at Visit 2 (Day -4). Mild burping and/or
flatulence totaling a 3-d score of >2 is acceptable.
2. Has a clinically significant GI-related reaction towards GI symptom-causing foods
(e.g., beans and legumes, vegetables high in inulin, sodas or fruit drinks, sugar
alcohols, inulin, fructooligosaccharides, gluten, and dairy products [see Appendix 3])
as judged by the Clinical Investigator.
3. Female subjects who typically experience change in GI symptoms or bowel habits (e.g.,
increased or decreased laxation, bloating, abdominal cramping) at the time of
menstruation. Subjects with these issues may be included if they are able to reliably
predict the onset and duration of their menstruation-related symptoms (e.g., always
occur only during the first two days of menses), in the judgment of the Clinical
Investigator. Test visits will be scheduled around menses.
4. Female subjects who is unwilling to wear a tampon during the collection of the 24-h
urine samples when these collections occur during the time of menstruation.
5. Abnormal laboratory test results of clinical significance at Visit 1 (Day -11), at the
discretion of the Clinical Investigator. One re-test will be allowed on a separate day
prior to Visit 2 (Day -4), for subjects with abnormal laboratory test results.
6. Clinically important GI condition that would potentially interfere with the evaluation
of the study products (e.g., inflammatory bowel disease, irritable bowel syndrome,
gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of
surgery for weight loss, gastroparesis, and clinically significant lactose or gluten
intolerance or other food or ingredient allergies).
7. Recent (within 2 weeks of Visit 1; Day -11) history of an episode of acute GI illness
such as nausea/vomiting or diarrhea (defined as =3 loose or liquid stools/d).
8. Self-reported history (within 6 weeks of Visit 1; Day -11) of constipation or diarrhea
at the discretion of the Clinical Investigator.
9. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma),
cardiac (including, but not limited to, atherosclerotic disease, history of myocardial
infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including
Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as
Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety
disorders) or biliary disorders. Conditions which are well-controlled or resolved will
be assessed by the Clinical Investigator on a case-by-case basis.
10. Uncontrolled hypertension (systolic blood pressure =140 mm Hg or diastolic blood
pressure =90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -11).
One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects
whose blood pressure exceeds either of these cut points at Visit 1 (Day -11), in the
judgment of the Clinical Investigator. If taken, the repeat blood pressure measurement
will be used to determine eligibility. Stable use of hypertension medication is
allowed [defined as no change in medication regimen within the 3 mo prior to Visit 1
(Day -11)].
11. Any known food allergy as well as intolerance or sensitivity to study product
ingredients (Appendix 13).
12. Extreme dietary habits or physical activity patterns at the discretion of the Clinical
Investigator.
13. History or presence of cancer in the prior 2 y, except for non-melanoma skin cancer.
14. Major trauma or any other surgical event within 3 mo of Visit 1 (Day -11).
15. Signs or symptoms of an active infection of clinical relevance within 5 d of Visit 1
(Day -11). The visit may be rescheduled such that all signs and symptoms have resolved
(at the discretion of the Clinical Investigator) at least 5 d prior to Visit 1 (Day
-11)*
16. Weight loss or gain > 4.5 kg in the 3 mo prior to Visit 1 (Day -11).
17. Currently or planning to be on a weight loss regimen during the study.
18. Antibiotic, antifungal, or antiparasitic use within 3 mo of Visit 1 (Day -11) and
throughout the study period.
19. Use of steroids within 1 mo of Visit 1 (Day -11) and throughout the study period. Use
of nasal and non-prescription topical treatments is allowed.
20. Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g.,
NSAIDS) within 1 mo of Visit 1 (Day -11).
21. Use of medications (over-the-counter or prescription) and/or dietary supplements,
known to influence GI function, including but not limited to prebiotics or probiotics,
laxatives, enemas, fiber supplements and/or suppositories, antacids, anti-diarrheal
agents, and/or anti-spasmodic within 3 weeks of Visit 1 (Day -11). Standard
multivitamin and mineral supplements are allowed.
22. Participated in endoscopy or endoscopy preparation within 3 mo prior to Visit 1 (Day
-11).
23. Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -11).
24. Female who is pregnant, planning to be pregnant during the study period, lactating, or
is of childbearing potential and is unwilling to commit to the use of a medically
approved form of contraception throughout the study period. Subjects who are pregnant
during the study will be discontinued.
25. Recent history (within 12 mo of screening; Visit 1; Day -11) of alcohol or substance
abuse. Alcohol abuse is defined as >14 drinks/week (1 drink = 12 oz beer, 5 oz wine,
or 1½ oz distilled spirits).
26. Has a condition the Clinical Investigator believes would interfere with his ability to
provide informed consent, comply with the study protocol, which might confound the
interpretation of the study results, or put the subject at undue risk.
|
