Cardiovascular Disease Clinical Trial
Official title:
Dose-Response Study of Probiotic Bacteria Bifidobacterium Animalis Subsp. Lactis BB-12 and Lactobacillus Paracasei Subsp. Paracasei CRL-341 in Healthy Young Adults
The purpose of the study was to investigate the dose-response effect of increasing doses of Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and overall tolerance in healthy young adults.
The study included seventy-one healthy young vounteers, and was designed as a double-blind
placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention
and 2 wk wash-out period. The subjects were randomly assigned into 5 groups of 15 subjects
each, who were supplemented with 0, 10E8, 10E9, 10E10 or 10E10 CFU/d, respectively, og a
mixture of BB-12 and CRL-431. Blood samples were collected 4 times and fecal samples 3
times. Diary reporting bowel habits and weel being was kept for all 7 weeks.
There are very few articles concerning the issue dose-response effect of probiotics.The aim
of the study was to investigate the dose-response effect of increasing concentrations of
probiotics on the immune response, blood lipids, composition of the gut microflora, recovery
from feces and the overall tolerance.
The hypothesis was that the increasing dose would influence the immunresponse (eg incresae
phagocytosis), improve blood lipid profile (eg.lower HDL-cholesterol), would be recovered in
increasing concentrations in feces, would change the intestinal microfloraprofile and would
be well tolerated even in high doses.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02122198 -
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
|
N/A | |
| Completed |
NCT02502812 -
Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04216342 -
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
| Completed |
NCT03646656 -
Heart Health Buddies: Peer Support to Decrease CVD Risk
|
N/A | |
| Completed |
NCT02081066 -
Identification of CETP as a Marker of Atherosclerosis
|
N/A | |
| Completed |
NCT02147626 -
Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia
|
N/A | |
| Not yet recruiting |
NCT06405880 -
Pharmacist Case Finding and Intervention for Vascular Prevention Trial
|
N/A | |
| Recruiting |
NCT03095261 -
Incentives in Cardiac Rehabilitation
|
N/A | |
| Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
| Completed |
NCT02868710 -
Individual Variability to Aerobic Exercise Training
|
N/A | |
| Completed |
NCT02589769 -
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
|
N/A | |
| Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
| Completed |
NCT02711878 -
Healing Hearts and Mending Minds in Older Adults Living With HIV
|
N/A | |
| Recruiting |
NCT02885792 -
Coronary Artery Disease in Patients Suffering From Schizophrenia
|
N/A | |
| Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
| Completed |
NCT02657382 -
Mental Stress Ischemia: Biofeedback Study
|
N/A | |
| Completed |
NCT02272946 -
Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
|
Phase 2 | |
| Completed |
NCT02640859 -
Investigation of Metabolic Risk in Korean Adults
|
||
| Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|