Clinical Trials Logo

Clinical Trial Summary

The purpose of this dietary intervention is to study the effects of several dietary fibers on the gut microbiota at the personal level. Hypothesis 1: Intake of specific dietary fibers improves the blood lipid profile depending on the personal microbiota of the participants. Hypothesis 2: detailed food intake analysis and continuous monitoring of gut microbiota enables to draw causative interrelationships between food components, bacteria of gut microbiome and health characteristics.


Clinical Trial Description

The study design is a cross-over, pre-post intervention trial. All participants are enrolled into all study periods. Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs. The main goal of this study was to elucidate the patterns between individual dietary fibers and gut microbiota at the personal level. Each person has a unique (individual) intestinal microbiological profile that changes according to lifestyle (diet, environment, physical activity), age and health status. With next generation sequencing methods to map microbial communities and detailed nutritional analysis including blood tests, it is possible to identify the specific effects of specific fiber on a selected (individual) microbiota. TFTAK researchers have long-term experience in microbiota analysis as well as diet design and nutrition analysis, which can be successfully applied in this project. PRELIMINARY STUDY EVALUATION AND TESTING 1. Complete preliminary study questionnaire 2. Complete orientation to the study and provide voluntary consent to join the study 3. Collection of coded intervention products, sampling supplies, and instructional materials 1-WEEK QUESTIONNAIRE AND LABORATORY VISIT 1. Record food intake and gastrointestinal function for 7 days 2. Collect health data and provide a 7-day food diary using web-based program Nutridata (tap.nutridata.ee) 3. Provide a stool and blood sample at the laboratory 3-WEEK QUESTIONNAIRE AND LABORATORY VISITS 1. Record food intake and gastrointestinal symptoms for 7 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES 1. Provide the blood sample at the laboratory in the morning in an overnight fasted state. DIETARY INTERVENTION Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs: 1. Baseline mapping (health questionnaire, 1 week food diary before sampling of blood and gut microbiota) 2. Dietary fiber 1, 3 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota 3. Wash-out period, 2 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota 4. Repeating 3 times periods of 2 and 3. In each dietary fiber period 15 g/day of oat fiber, rye fiber, mix I and mix II of dietary fibers are used as test compounds. Dietary fiber mix I and mix II are inulin, beta-glucan, polydextrose, citrus pectin and psyllium, and beta-glucan, citrus pectin and psyllium, respectively. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05424640
Study type Interventional
Source Center of Food and Fermentation Technologies
Contact
Status Active, not recruiting
Phase N/A
Start date February 1, 2022
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Recruiting NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Completed NCT04052711 - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design Phase 1
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT04451811 - A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers Phase 1
Completed NCT04319926 - Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects Phase 1
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Completed NCT05005065 - Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians Phase 1
Completed NCT05392816 - Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein N/A