CONSORT flow chart for the study.
autoimmune disorders, cancer, gall bladder, anxiety
AUTOIMMUNE DISORDERS, CANCER, MINOR, HEMOLYTIC ANEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS, ACUTE INFECTIONS, FOOD ALLERGIES
The screening involved an interview to document age, body mass index (BMI), medical/surgical history, diet and lifestyle, current health status, medication, and use of nutritional supplements. The following inclusion criteria were applied: Healthy adult people of either gender, age 18–75 years (inclusive), body mass index (BMI) between 18.0 and 34.9 kg/mThe following exclusion criteria were used: Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder); taking anti-inflammatory medications on a daily basis; currently in intensive athletic training (such as marathon runners); cancer during past 12 months; chemotherapy during past 12 months; currently treated with immune suppressant medication; diagnosed with autoimmune disorders e.g. systemic lupus erythematosus, hemolytic anemia; donation of blood during the study or within the 4 weeks prior to study start; received a cortisone shot within past 12 weeks; immunization during last month; currently taking antipsychotic hypnotic, or anti-depressant prescription medication; ongoing acute infections (including teeth, sinus, ear, etc.); participation in another clinical trial study during this trial, involving an investigational product or lifestyle change; an unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); unwilling to maintain a constant intake of supplements over the duration of the study; anxiety about having blood drawn; pregnant, nursing, or trying to become pregnant; known food allergies related to ingredients in active test product or placebo. If subjects met the inclusion and exclusion criteria, they were informed that they qualified, and scheduled for clinic visits where they were enrolled into the study upon providing written informed consent. Randomization was performed by assigning the first female study participant to consume product code A on the first clinic visit and consume product code C for her second clinic visit. The sequence alternated for each subsequent female person enrolled. The process was the same for male participants with the first male participant consuming product C on the first clinic visit. The principal investigator generated the random allocation sequence without knowing which participant would be assigned to which sequence. Clinic staff enrolled participants and the scheduling determined the allocation to sequence. All clinic staff were blinded, and blinding was performed by the study sponsor.Study participants were scheduled for two clinic visits 1 week apart. For each participant, the visits were scheduled at the same time of the day during the morning hours of 7–11 am to minimize the effect of circadian fluctuations [Below is a simplified diagram illustrating the involvement of each participant, where all study participants were tested on two different clinic days separated by a 1-week wash-out period.