Investigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Dose Response Study
Mots clés
Abstrait
Rendez-vous
Dernière vérification: | 06/30/2018 |
Première soumission: | 09/21/2009 |
Inscription estimée soumise: | 09/30/2009 |
Première publication: | 10/01/2009 |
Dernière mise à jour soumise: | 07/19/2018 |
Dernière mise à jour publiée: | 07/22/2018 |
Date de début réelle de l'étude: | 05/31/2009 |
Date d'achèvement primaire estimée: | 08/30/2011 |
Date estimée d'achèvement de l'étude: | 07/19/2018 |
Condition ou maladie
Intervention / traitement
Dietary Supplement: Fructan - 7.5
Dietary Supplement: Fructan - 10 grams
Dietary Supplement: Fructan - 12.5 grams
Dietary Supplement: 5 grams Fructan
Phase
Groupes d'armes
Bras | Intervention / traitement |
---|---|
Experimental: Fructan - 7.5 Subjects will consume 7.5 grams of fructan | Dietary Supplement: Fructan - 7.5 Subjects will consume 7.5 grams of fructan |
Experimental: Fructan - 10 grams Subjects will consume 10 grams of fructan | Dietary Supplement: Fructan - 10 grams Subjects will consume 10 grams of fructan |
Experimental: Fructan - 12.5 grams Subjects will consume 12.5 grams of fructan | Dietary Supplement: Fructan - 12.5 grams Subjects will consume 12.5 grams of fructan |
Experimental: 5 grams Fructan Experimental - 5 grams Fructan
Subjects will consume 5 grams of Fructan. | Dietary Supplement: 5 grams Fructan Subjects will consume 5 grams fructan. |
Critère d'éligibilité
Âges éligibles aux études | 18 Years À 18 Years |
Sexes éligibles à l'étude | All |
Accepte les bénévoles en santé | Oui |
Critères | Inclusion Criteria: - Healthy volunteers between the ages of 18-70 years, with no previous history of gastrointestinal problems or any other ailments, no history of gastrointestinal surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy and currently not using any medication except contraceptive pill, multivitamin, or aspirin. - They will be asked to fill out a Review of Systems health history (Appendix 2) and the Mayo Clinic Bowel Disease Questionnaire (Appendix 3) and will undergo a routine physical examination. Only patients who are asymptomatic and deemed healthy from the aforementioned screening procedure will be eligible. Exclusion Criteria: - Currently taking medication for any ailment including OTC medication (excluding aspirin, multivitamins, and oral contraceptives) - History of gastrointestinal problems including bloating, gas, food intolerances or reflux symptoms - Any major abdominal surgery (except appendectomy, cholecystectomy, caesarean section, hysterectomy) or coexisting medical problem - Known food allergies - Prisoners - Cognitive Impairment or any other inability to provide informed consent |
Résultat
Mesures des résultats primaires
1. Hydrogen and Methane Concentration levels [3 visits over a 1 month period]
Mesures des résultats secondaires
1. Production of GI Symptoms [3 visits over a 1 month period]