Gut Microbiome Clinical Trial
Official title:
Evaluating the Effects of Corn Flour Consumption on Cardio-metabolic Outcomes and the Gut Microbiome in Adults With High Cholesterol
The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.
Dietary fibers are extremely complex and foster health in a variety of ways that are not fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013). While cereal fibers have been shown to be most effective at reducing cardiovascular disease risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary fiber (natural and synthetic) have been shown to increase beneficial microbial species in the gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic disease markers. Very little is known about how isolated or intact fiber in whole grains solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes in cardiometabolic outcomes and the gut microbiome after consuming different types of corn-based meals. Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design. Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05793112 -
INF108F in Infants With Food Protein Induced Proctocolitis
|
Phase 4 | |
Active, not recruiting |
NCT04327141 -
Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women
|
N/A | |
Recruiting |
NCT04117321 -
Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
|
||
Recruiting |
NCT05655910 -
Enhanced Nutritional Optimization in LVAD Trial
|
N/A | |
Recruiting |
NCT03325855 -
Fecal Microbiota Transplant National Registry
|
||
Active, not recruiting |
NCT05931471 -
Yogurt and GI Health
|
N/A | |
Recruiting |
NCT03797417 -
Gut Microbiome and Metabolic Pathways Changes in Vitiligo
|
||
Withdrawn |
NCT06006416 -
Effect of Fenugreek Fibre on Gut Microbiome
|
Phase 3 | |
Recruiting |
NCT06206486 -
The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation
|
||
Completed |
NCT02655250 -
Neonatal Microbiome Validity Study
|
||
Recruiting |
NCT05670288 -
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
|
||
Not yet recruiting |
NCT03975764 -
Fecal Microbiota in Preterm Birth
|
||
Completed |
NCT03219931 -
NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants
|
Phase 4 | |
Recruiting |
NCT04447365 -
The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.
|
||
Recruiting |
NCT04466072 -
Gut Microbiome and Ventricular Arrhythmias
|
||
Not yet recruiting |
NCT06130137 -
Gut Microbiome in People Living With HIV and HBV
|
||
Recruiting |
NCT06260579 -
Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
|
N/A | |
Completed |
NCT04511052 -
Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06424691 -
Infant Restore: Efficacy of Microbiome Analysis and Education
|
N/A | |
Recruiting |
NCT06404749 -
Fungal Fiber for Gut Health
|
N/A |