Gastrointestinal Tolerance Clinical Trial
Official title:
A Randomized, Placebo-controlled, Crossover Study to Investigate the Effect of Arabinoxylan on Gastrointestinal Tolerance and Microbial Changes in Generally Healthy Adults.
The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults. The study is a randomized, placebo-controlled, crossover, single-center trial with 3 study periods separated by minimum 2-week washout periods. 45 healthy adults will be recruited for the trial. Participants will be required to drink a beverage twice a day for 3 weeks during each study period. The beverage will contain either approximately 7.25 grams of Arabinoxylan leaf fiber extract per day, or approximately 14.5 grams of Arabinoxylan leaf fiber extract per day, or will not contain any Arabinoxylan (control). Subjects will record their bowel movements daily, fill out daily questionnaires about their gastrointestinal systems, and record their food intake at specified times during the study. Stool samples will also be collected prior to and at the end of each study period for analysis of bacteria composition.
The study is a randomized, placebo-controlled, crossover, single-center trial with one
screening visit (Visit 1; Week -1) and 3 test periods [Test Period 1 (Visits 2 and 3; Weeks 0
to 3), Test Period 2 (Visits 4 and 5; Weeks 5 to 8), and Test Period 3 (Visits 6 and 7; Weeks
10 to 13)] separated by minimum 2-week washout periods.
At Visit 1 (Week -1), subjects will provide informed consent and undergo assessments of
medical history and prior, current medication/supplement use, and inclusion and exclusion
criteria and a last menses query, where applicable. Additionally, height, body weight, and
vital signs will be measured and BMI will be calculated. Fasting (12 ± 2 h) blood samples
will be collected for chemistry and hematology, and female subjects will undergo an in-clinic
urine pregnancy test. Subjects will be instructed to maintain physical activity and habitual
diet as much as possible with the exception of excluding fermented foods or beverages that do
or might contain live probiotics (e.g., yogurt, kombucha). Subjects will be dispensed a
Baseline Diet Diary with instructions to record intake 7 days prior to Visit 2 (Week 0).
Subjects will also be dispensed a Bowel Habits Diary and Daily GI Tolerance Questionnaire
with instructions to complete these during the 7 days prior to Visit 2 (Week 0). Finally,
subjects will be dispensed a stool collection kit and will be instructed to collect one fecal
sample from one bowel movement during the 3 days prior to Visit 2 (Week 0). Subjects will be
reminded that they are not required to fast prior to Visit 2 (Week 0) and will be encouraged
to eat breakfast prior to their visit.
At Visit 2 (Week 0), subjects will arrive at the clinic to undergo clinic visit procedures
(concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight and
vital signs measurements, last menses query, where applicable). Subjects will be queried
about compliance with study instructions. The fecal sample will be collected and the Bowel
Habits Diary, Baseline Diet Diary, and Daily GI Tolerance Questionnaire will be collected and
reviewed. Subjects will be assigned to a randomization sequence. The first study product
consumption will occur in the clinic and subject will be dispensed the remaining study
products according to their assigned randomization sequence for home consumption (twice a
day, once in the morning and once in the evening, with or without food). Subjects who
consumed breakfast at home prior to arriving at the clinic will be administered the study
product alone while those who did not consume breakfast prior to arriving at the clinic will
be administered the study product with a snack. Subjects will also be dispensed a Study
Product Diary to record study product intake. Subjects will be dispensed a copy of the last 5
days of their completed Baseline Diet Diary (reviewed at Visit 2, Week 0) and will be
instructed to replicate the same food and beverage intake as closely as possible during the
days prior to the collection of their fecal sample, which will occur during the 3 days
immediately prior to Visit 3 (Week 3). Additionally, subjects will be dispensed 3-day
Analysis Diet Records with instructions to record all food and beverages consumed during 3
days (2 weekdays and one weekend) following Visit 2 (Week 0) and before Visit 3 (Week 3) that
do not coincide with the 5 replication days immediately prior to Visit 3 (Week 3). Subjects
will be dispensed a Bowel Habits Diary and stool collection kit, and will be instructed to
complete the Bowel Habits Diary during the 7 days immediately prior to Visit 3 (Week 3) and
to collect a fecal sample from one bowel movement during the 3 days immediately prior to
Visit 3 (Week 3). Subjects will also be dispensed a Daily GI Tolerance Questionnaire with
instructions to complete the questionnaire daily starting from Visit 2 (Week 0) up to Visit 3
(Week 3). Finally, study instructions will also be provided [(i.e., overnight fasting (12 ± 2
h, water only), maintenance of physical activity with the exception of avoiding vigorous
physical activity for 24 h prior; maintenance of habitual diet as much as possible with the
exception of avoiding alcohol for 24 h prior and excluding fermented foods or beverages that
do or might contain live probiotics (e.g., yogurt, kombucha) and consumption of study
products].
At Visit 3 (Week 3), subjects will arrive at the clinic to undergo clinic visit procedures
(concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight, and
vital signs measurements, last menses query, where applicable) and adverse event (AE)
assessments. Subjects will be queried about compliance with study instructions and diet
replication. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology.
Fecal samples will be collected and the Bowel Habits Diary, Daily GI Tolerance Questionnaire,
and the 3-day Analysis Diet Record will be collected and reviewed. The Study Product Diary
will be collected/reviewed, any unused study products will be collected, and compliance with
study product consumption will be assessed. The Product Likeability Questionnaire will be
administered in clinic. Subjects will be dispensed a stool collection kit and will be
instructed to collect a fecal sample from one bowel movement during the 3 days immediately
prior to Visit 4 (Week 5). Subjects will also be dispensed a copy of the last 5 days of their
completed Baseline Diet Diary (reviewed at Visit 2, Week 0) and will be instructed to
replicate the same food and beverage intake as closely as possible during the days prior to
the collection of their fecal sample, which will occur during the 3 days immediately prior to
Visit 4 (Week 5). Subjects will also be instructed to begin the 2-week washout period and
return to the clinic to begin Test Period 2 at Visit 4 (Week 5). Finally, study instructions
will also be provided [(i.e., maintenance of physical activity; maintenance of habitual diet
as much as possible with the exception of excluding fermented foods or beverages that do or
might contain live probiotics (e.g., yogurt, kombucha)]. Subjects will also be reminded that
they are not required to fast prior to Visit 4 (Week 5) and will be encouraged to eat
breakfast prior to their visit.
At Visit 4 (Week 5), subjects will return to the clinic, crossover to the other study product
in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exception
of the randomization procedure. At Visit 5 (Week 8), subjects will repeat the procedures from
Visit 3 (Week 3), followed by a 2-week washout period before starting Test Period 3 at Visit
6 (Week 10). At Visit 6 (Week 10), subjects will return to the clinic, crossover to the other
study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with
the exception of the randomization procedure. Finally, at Visit 7 (Week 13), subjects will
repeat the procedures from Visit 3 (Week 3).
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