Healthy Adults Clinical Trial
Official title:
Impact of Galacto-oligosaccharides on the Intestinal Microbial Composition and -Activity: a Proof of Concept Study
Dietary intake of galacto-oligosaccharides (GOS) may have beneficial effects on host health by affecting the microbiota composition and -activity. So far studies focused on analyses in fecal samples, while the primary site of carbohydrate fermentation is the proximal colon. To date, no studies have been performed in humans on the more proximal microbiota and the impact of fermentable carbohydrates. Further insights on the more proximal colonic microbiota would aid to targeted approaches to improve intestinal health. Therefore, we aim to study the effect of GOS on the intestinal microbiota composition and -activity in healthy adults, by sampling the more proximal human colon in a physiological condition. The primary objective of this study is to investigate the impact of four weeks GOS supplementation on intestinal microbiota composition and -activity, by sampling the proximal part of the human colon in a physiological condition. Furthermore, this study has four secondary objectives: First, to compare the intestinal microbiota composition and -activity of the proximal colon vs. distal colon at baseline and after four weeks GOS supplementation. Second, compare the luminal microbiota composition vs. mucosa adherent microbiota composition of the proximal vs. distal colon at baseline and after four weeks GOS supplementation. Third, monitor the effects of four weeks GOS supplementation on gastrointestinal symptoms. The study conforms to a randomized, double-blind, placebo-controlled, parallel design. Study population includes healthy human volunteers (male and female), 18-50 years of age. One intervention arm will include 7.2 grams of Vivinal® GOS Powder three times daily for four weeks. The other intervention arm subjects will receive placebo product (7.2 grams maltodextrin) three times daily for four weeks. At the start and end of the intervention period, several measurements will take place. The main study parameter is the change in microbial composition and -activity induced by GOS intervention.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04677920 -
The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology
|
N/A | |
| Active, not recruiting |
NCT03312920 -
Investigating Memory Retrieval Improvement in Healthy Subjects
|
N/A | |
| Completed |
NCT03309072 -
Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task
|
N/A | |
| Completed |
NCT03289832 -
Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin
|
N/A | |
| Enrolling by invitation |
NCT06133530 -
Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica
|
N/A | |
| Completed |
NCT05141903 -
Dietary Supplement With and Without a Probiotic and/or Antibiotic
|
||
| Completed |
NCT01689259 -
Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01187875 -
Resistant Starch and Satiety
|
Phase 0 | |
| Completed |
NCT03312699 -
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
|
Phase 1 | |
| Completed |
NCT03319134 -
Investigating the Neural Correlates in Memory Retrieval After HD-tDCS
|
N/A | |
| Completed |
NCT03228693 -
Gene Expression and Biomarker Profiling of Keloid Skin
|
N/A | |
| Completed |
NCT04146532 -
Aspirin Effects on Emotional Reactions
|
Early Phase 1 | |
| Completed |
NCT04206293 -
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
|
N/A | |
| Recruiting |
NCT06011018 -
Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
|
N/A | |
| Completed |
NCT05093205 -
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
|
Phase 1 | |
| Completed |
NCT04596709 -
Investigation of Blood Glucose and Insulin Response After Intake of Vitalose
|
N/A | |
| Completed |
NCT04272450 -
Respiratory Muscle Strength in Different Age Groups
|
||
| Completed |
NCT02044679 -
Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions
|
N/A | |
| Completed |
NCT01402973 -
Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products
|
N/A | |
| Completed |
NCT01322503 -
Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus
|
Phase 1 |