Healthy adult
Conditions
Interventions
Intake of gluten-free foods for 4 consecutive weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females from 18 to 64 years of age (2) Subjects with BMI level of 18.5 or more and less than 25.0 kg/m2 (3) Subjects who intake wheat processed food as staple food 14 or more per week and correspond to (A) or (B) (A) Subjects who do not feel any particular change in their physical condition (B) Subjects who are aware of abdominal symptom Conditions corresponding to (B), either or both of following (i) abdominal symptom, 1 or more of the following: postprandial fullness, early satiation, epigastric pain, and epigastric burning, which are unexplained after a routine clinical evaluation; and includes 2 subcategories: postprandial distress syndrome that is characterized by meal-induced dyspeptic symptoms and epigastric pain syndrome that does not occur exclusively postprandially; the 2 subgroups can overlap (ii) abdominal symptom, Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool: a criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis (4) Subjects who can limit their intake of processed wheat foods during the intervention period (5) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: (1) Subjects who has been diagnosed digestive system disease (2) Subjects who have allergies related to a food (3) Subjects who may develop allergies in relation to the study (4) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study (5) Subjects who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication, and those who are scheduled for surgery (6) Subjects whose physical measurements before the start of intake were significantly out of the reference range (7) Subjects who work in shifts, work late at night, and have an irregular daily rhythm (8) Subjects who have participated in other clinical trials within one month prior to obtaining consent to participate in this study (9) Subjects who cannot intake gluten-free foods during the intervention due to the vacation, business trip or the event (10) Subjects who plan to change daily habits during the study (11) Subjects who eat a large amount of food at a time compared to the average amount of meals (12) Subjects who have difficulty in keeping a diary. (13) Subjects who plan to become pregnant or breastfeed during the study (14) Subjects who are judged to be inappropriate as study subjects based on their answers to the lifestyle questionnaire (15) Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abdominal symptom | — |
Secondary
| Measure | Time frame |
|---|---|
| blood examination, feces examination, QOL questionnaire | — |
Countries
Japan
Contacts
Public ContactKaori Yoshimoto
EP Mediate Co., Ltd. Development Department
Outcome results
None listed