Efficacy of a Whole Cell Algae Fermentate on Gut Health and Overall Immune Function in Healthy Adults With Mild Gastrointestinal Issues
Condition: Healthy; Gastrointestinal Dysfunction; Cold Symptom; Flu Symptom
Study type: Interventional

Summary: 
      The objective of the current study is to evaluate the effect of whole cell fermentate on gut
      health, including GI system function, such as supporting consistency and regularity of bowel
      habits, as well as changes in microbiota. The role of the GI system can also be extended to
      immune regulation because approximately 70% of the entire immune system in the body is
      located around the gut. Thus, the health and wellbeing of the gut can have a great impact on
      whole-body health. Therefore, this study will assess the effect on overall immune function.
    

Detailed description: 
      This study is a randomized, placebo-controlled, crossover trial with a screening visit and
      two test periods separated by a three-week washout period.

      At Visit 1, after subjects have provided informed consent, medical history will be reviewed
      and clinic visit procedures will be performed, including assessments of prior/current
      medication/supplement use, and evaluations of inclusion/exclusion criteria.Subjects will be
      dispensed a diet record, gastrointestinal questionnaire, bowel habits diary, upper
      respiratory symptom questionnaire, and a stool collection kit to complete prior to Visit 2
      (week 0).

      At Visit 2 (week 0), eligible subjects will return to the clinic. The stool samples will be
      collected, and the diet record, gastrointestinal questionnaire, and bowel habits diary will
      be collected. Subjects will also be administered a stress questionnaire and quality of life
      questionnaire. Eligible subjects will then be randomized to one of two test groups (placebo
      or active). Subjects will track study product intake using a daily study product log and
      track daily cold symptoms. Subjects will also be given a gastrointestinal questionnaire,
      bowel habits diary, upper respiratory symptom questionnaire, and a stool collection kit to
      complete prior to Visit 3 (week 4).

      At Visit 3 (week 4), the stool samples will be collected, and the diet record,
      gastrointestinal questionnaire, and bowel habits diary will be collected. Subjects will also
      be administered a stress and quality of life questionnaire. Unused study product will be
      collected and compliance assessed via unused study product.Subjects will also be given a
      gastrointestinal questionnaire, bowel habits diary, and a stool collection kit to complete
      prior to Visit 4 (week 7)

      Subjects will then enter the 3-week washout period, during which time no
      surveys/questionnaires will be kept and will then crossover to the other study product in
      their test sequence and repeat the Test Period I procedures (at Visit 2 and 3) during Test
      Period II (Visits 4 [week 7] and 5 [week 11]).
    

Intervention name(s): Whole Cell Algae Fermentate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Contains at minimum 50% Beta Glucan; microcrystalline cellulose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Double-blind, Placebo-Controlled, Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research