Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 07/31/2013 |
Pirmasis pateikimas: | 08/22/2013 |
Numatytas registravimas pateiktas: | 08/28/2013 |
Pirmas paskelbtas: | 08/29/2013 |
Paskutinis atnaujinimas pateiktas: | 08/28/2013 |
Paskutinis atnaujinimas paskelbtas: | 08/29/2013 |
Faktinė studijų pradžios data: | 06/30/2012 |
Numatoma pirminio užbaigimo data: | 10/31/2012 |
Numatoma studijų užbaigimo data: | 10/31/2012 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: Perilla extract
Dietary Supplement: Maltodextrin
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Perilla extract Experimental arm: Perilla extract | Dietary Supplement: Perilla extract |
Placebo Comparator: Maltodextrin Placebo arm: Maltodextrin | Dietary Supplement: Maltodextrin |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 30 Years Į 30 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility. - BMI: 19-30 kg/m2 - Reduced bowel movements defined as an average of >1 and ≤ 3.5 stools per week for at least the previous 6 months - Gastrointestinal symptoms of at least 5 points - Male or female - Age ≥ 30 and ≤ 70 years - Nonsmoker - Written consent to participate in the study - Able and willing to follow the study protocol procedures Exclusion Criteria: - Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries - Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening - Subjects with stool frequency of ≤ 1 stool every 7 days or > 3,5 stools per week - Subjects not willing to avoid pre- and probiotics for the duration of the study - Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks - Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers) - Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject. - Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study. - Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results. - Known food intolerance or allergy. - Subject involved in any clinical or food study within the preceding month |
Rezultatas
Pirminės rezultatų priemonės
1. daily gastrointestinal symptoms [was assessed daily during 4 week intervention]
Antrinės rezultatų priemonės
1. validated questionnaires [assessed at visit 1 (before) and at visit 2 (after 4 week intervention)]
2. stool consistency [reported at days with stool during 4 week intervention]
3. Adverse events [assessed at visit 1 (before) and at visit 2 (after 4 week intervention)]
4. Stool frequency [reported at days with stool during 4 week intervention]