Dietary Fibers Effect on the Gut Microbiota Composition
Anahtar kelimeler
Öz
Açıklama
A randomized double-blinded study will include 270 volunteers without clinical manifestations of chronic diseases. Participants will be randomized into one of five arms daily consuming one of the following: placebo (maltodextrin, 8 g), inulin (8 g), pectin (8 g), beta-glucan (8 g) or oligosaccharides (8 g).
The study will include a 5-day screening period and a 5-weeks intervention period.
During screening stage, a volunteer will complete a questionnaire, and the following measurements will be performed: blood levels of glycated hemoglobin, creatinine, lipids, C-reactive protein, anthropometric measurements, as well as cardiovascular risk will be assessed.
Before and after the intervention blood and stool samples will be collected to conduct the following analyses: an extended lipid spectrum analysis, high-sensitivity C-reactive protein, 16S rRNA gut microbiome sequencing, laboratory stool testing, stool fecal short-chain fatty acids analysis. Anthropometric measures, physical examination will be performed for each volunteer. The following questionnaires will be completed: dietary recall questionnaire, SF-36, the Rome Criteria for the Functional gastrointestinal disorders (functional constipation). The assessed scales will include Bristol stool scale, Hospital Anxiety and Depression Scale (HADS), Hamilton Rating Scale for Depression (HRSD).
Tarih
| Son Doğrulandı: | 08/31/2019 |
| İlk Gönderilen: | 09/26/2019 |
| Tahmini Kayıt Gönderildi: | 10/01/2019 |
| İlk Gönderilen: | 10/02/2019 |
| Son Güncelleme Gönderildi: | 11/27/2019 |
| Son Güncelleme Gönderildi: | 12/01/2019 |
| Fiili Çalışma Başlangıç Tarihi: | 11/24/2019 |
| Tahmini Birincil Tamamlanma Tarihi: | 05/31/2021 |
| Tahmini Çalışma Tamamlanma Tarihi: | 12/30/2021 |
Durum veya hastalık
Müdahale / tedavi
Dietary Supplement: Maltodextrin
Dietary Supplement: Inulin
Dietary Supplement: Pectin
Dietary Supplement: Beta-glucan
Dietary Supplement: Galactooligosaccharides
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Placebo Comparator: Maltodextrin Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. | Dietary Supplement: Maltodextrin NOVAPRODUKT, white powder 5 weeks intervention |
| Experimental: Inulin Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. | Dietary Supplement: Inulin BENEO-Orafti, white powder 5 weeks intervention |
| Experimental: Pectin Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. | Dietary Supplement: Pectin BANG & BONSOMER GROUP OY, white powder 5 weeks intervention |
| Experimental: Beta-glucan Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. | Dietary Supplement: Beta-glucan Tate & Lyle, white powder 5 weeks intervention |
| Experimental: Galactooligosaccharides Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. | Dietary Supplement: Galactooligosaccharides FrieslandCampina, white powder 5 weeks intervention |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | Inclusion Criteria: - Subject doesn't have any active complaints - Subject doesn't have any active or acute diseases at the time of enrollment - Subject signed informed consent Exclusion Criteria: - High or very high cardiovascular risk - Levels of total cholesterol and/or low-density lipoproteins requiring immediate assignment of drug treatment (according to ESC Guidelines for the management of dyslipidaemias, 2019) - Diabetes mellitus of any type - HbA1с of 5,7% or higher - Obesity requiring medical therapy or surgery (according to European Guidelines for Adult Obesity Management, 2019) - Gastrointestinal diseases in history including ulcerative colitis, Crohn's disease, celiac disease, gallbladder disease (calculous cholecystitis, cholangitis, etc.) not related to functional disorders; liver or pancreas diseases - Irritable bowel syndrome, abdominal pain of any location and etiology - Pain syndrome of any localization - Flatulence - Oncology diseases - Mental disorders - Rheumatoid arthritis or other autoimmune diseases - Acute infectious diseases or exacerbation of any diseases - Recent (<3 months) administration of proton pump inhibitors, antimicrobial therapy or surgical intervention - Recent (<3 weeks) use of probiotics, antacids, nonsteroidal anti-inflammatory drugs, laxatives - Pregnancy, planning to be pregnant or breast feeding at any point during the study or study enrollment - Current alcohol/drug abuse (more than 3 points for women and 4 for men according to AUDIT-C questionnaire and/or more than 7 points on the AUDIT questionnaire) or addiction therapy within 12 months prior to screening - Allergies to any prebiotic or placebo ingredients - Planned relocation from the home region during the study |
Sonuç
Birincil Sonuç Ölçütleri
1. Blood lipids levels [Change from Baseline Blood lipids levels at 5th week]
2. Change in Gut microbiota composition [Change from Baseline at 5th week]
İkincil Sonuç Ölçütleri
1. Change in Fecal short-chain fatty acids [Change from Baseline at 5th week]
2. Change in High sensitive C-reactive protein [Change from Baseline at 5th week]
3. Change in Stool consistency [Change from Baseline at 5th week]
4. Change in Stool frequency [Change from Baseline at 5th week]
5. Change in Body Composition [Baseline and 5th week]
6. Change in Quality of Life: SF-36 questionnaire [Change from Baseline at 5th week]
7. Change in Psychological distress [Change from Baseline at 5th week]
