Efficacy of Pea Hull Fibre Supplementation

A 10-week randomized, cross-over study will be carried out to assess the efficacy of pea hull
fiber. Participants will complete a 2-week baseline period during which appetite,
gastrointestinal symptoms, stool frequency, and stool consistency (transit time) will be
collected by paper questionnaire, and participants will collect a single stool. Dietary data
(24-hour dietary recalls) will be obtained via phone interviews 3 times during the baseline
period. On or about day 15, participants will attend a study visit and complete the
Simplified Nutritional Appetite Questionnaire (SNAQ) and Gastrointestinal Symptom Response
Scale (GSRS). Participants will be randomized on or about day 15 and consume snacks without
pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week
treatment period separated by a 2-week washout period. In both intervention periods,
participants will complete daily questionnaires to assess appetite, gastrointestinal
symptoms, and stool frequency and consistency (transit time). Furthermore, they will complete
SNAQ and GSRS after the end of each intervention period. The 24-hour dietary recalls will
also be collected 3 times during each of the intervention periods. Participants will undergo
an additional 2-week washout period after the second intervention period. During washout
periods, the same data will be collected as was done during the baseline and intervention
periods.Participants will be asked to collect one stool during pre-baseline and weeks 4, 6, 8
and 10 for a total of 5 stools. Stool samples will be analyzed for changes in the microbiota.

Inclusion Criteria:

- Willing to have height and weight measured and provide demographic information (e.g.
age, race, sex).

- Willing to consume pea hull fiber and control snacks daily each for a 2-week period

- Willing to complete a daily questionnaire regarding general and gastrointestinal
wellness throughout the entire 10-weeks study.

- Willing to complete the GSRS (Gastrointestinal Symptom Rating Scale) and SNAQ
questionnaires bi-weekly at study appointments.

- Willing to be interviewed for a 24-hr food recall, 3 times per 2-weeks period
throughout the study.

- Willing to provide 5 stool samples, one in each 2-weeks period throughout the study.

- Willing and be able to provide a valid social security for study payment purposes.

Exclusion Criteria:

- Have any known food allergies.

- Are currently taking medications for diarrhea.

- Have taken antibiotics within the past four weeks prior to randomization.

- Are currently taking probiotics supplements and do not want to discontinue a minimum
of two weeks prior to the study.

- Have previously or are currently being treated for any diseases or illnesses such as
gastrointestinal disease (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).