Efficacy study of two dietary supplements, one based on resistant dextrin from wheat starch, fibers from Citrus spp. (pectin), and fibers from oat (Avena sativa L.), one based on resistant dextrin from wheat starch, fibers from carob (Ceratonia siliqua L.), and fibers from oat (Avena sativa L.), on intestinal function in subjects with primary functional constipation: single-center, placebo-controlled, randomized clinical study, parallel arms, double-blind.
Chronic primary functional constipation
The subjects recruited in the present clinical study have been randomized into the following experimental groups: GROUP 1 - subjects who received the dietary supplement (TREATMENT A) containing resistant dextrin from wheat starch, fibers from Citrus spp. (pectins), and fibers from oats (Avena sativa L.) GROUP 2 - subjects who received the dietary supplement (TREATMENT B) containing resistant dextrin from wheat starch, fibers from carob (Ceratonia siliqua L.), and fibers from oats (Avena sativa L.) GROUP 3 - subjects who received the placebo. The treatment period duration was 1 month. To maintain the double-blind design, the three treatments will be unrecognizable, as the packaging is identical, and the dosage forms are the same color, shape, weight, and taste. The randomization sequence has been generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list has been kept hidden. The participants were assigned to each of the three treatments randomly and unpredictably, through simple randomization. The randomization code will consist of a three-digit number as indicated in the respective Case Report Form (CRF). In the clinical study, 81 participants will be enrolled and divided into three groups (27 for each group): GROUP 1 (27 subjects) - subjects who received the dietary supplement (TREATMENT A) containing resistant dextrin from wheat starch, fibers from Citrus spp. (pectins), and fibers from oats (Avena sativa L.), GROUP 2 (27 subjects) - subjects who received the dietary supplement (TREATMENT B) containing resistant dextrin from wheat starch, fibers from carob (Ceratonia siliqua L.), and fibers from oats (Avena sativa L.), GROUP 3 (27 subjects) - subjects who received the placebo. Participants underwent three visits (at the start of the run-in period of 28 days = tr, and at the end of the run-in period and the start of the treatment period (baseline) = t0
1. Age ranging from 18 to 70 years 2. Able to understand and sign the informed consent 3. Negative HIV test 4. Negative pregnancy test 5. Able to understand and adhere to the protocol requirements 6. Experiencing symptoms of chronic constipation for at least 3 months (with onset at least 6 months prior) 7. Absent or non-dominant, occurring less than once a week, and thus not affected by IBS-C 8. Subjects had to have fewer than three SCBM per week and meet at least one of the following conditions: 8.1. Straining during more than 25% of bowel movements 8.2. Passage of lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements 8.3. Sensation of incomplete evacuation in more than 25% of bowel movements 8.4. Sensation of anorectal obstruction/blockage in more than 25% of bowel movements 8.5. Use of manual maneuvers to facilitate bowel movements in more than 25% of bowel movements 9. Subjects who were not taking and would not take any type of medication throughout the study period
1. Age less than 18 or greater than 70 years 2. In a state of pregnancy or breastfeeding 3. Abdominal pain occurring at least once a week (subjects with IBS) 4. Subjects with organic intestinal diseases 5. Subjects with a history of gastrointestinal surgery 6. Subjects with gastroesophageal reflux 7. Subjects with Parkinson's disease or Alzheimer's disease 8. Subjects using opioid medications or other drugs with a significant impact on intestinal function (e.g., antidepressants, aluminum-containing antacids), subjects who are currently taking or have taken antibiotics within the past four weeks, or within the past six months depending on the intensity and duration of the antibiotic treatment, and subjects taking medications for other conditions 9. Subjects who abuse alcohol, drugs, caffeine, or theine 10. Subjects with cognitive impairments that may hinder their ability to respond to questionnaires 11. Subjects with a known allergy to the ingredients of the experimental products (active or placebo) 12. Subjects with acquired immunodeficiency syndrome (AIDS) due to HIV