Inflammation Clinical Trial
Official title:
Effect of Full-Fat and Fat-Free Dairy, With and Without Fermentation, on Fecal Microbiome, Fecal and Serum Metabolome, and Host Cardiometabolic Risk Status
The purpose of the study is to compare the effect of consuming full-fat (regular) and fat-free (skim) milk, as well as full-fat and fat-free yogurt (a fermented dairy product), on microorganisms in your gut as well as the products produced by the gut microbes. We will also determine whether consuming these dairy products affects risk factors for heart disease.The findings of the study will help us determine if heart disease risk factors are modified by the fat content and fermentation of milk. The results may facilitate refinement of public health dietary guidance for cardiovascular disease risk reduction.
A randomized-controlled cross-over trial will be conducted to compare the effect of two servings per day of full-fat and fat-free milk, and full-fat and fat-free yogurt (hence forth referred to as dairy food items) on the gut microbiome, fecal and serum metabolome, and determine their relation to cardiometabolic risk factors (CMRF) and functional pathways associated with the differences identified. Participants will be provided with 2 servings per day of the test dairy products and requested not to consume additional bovine (cow) milk or yogurt during each 3-week diet phase.They will be allowed to use dairy substitutes such as plant-based milk alternatives and consume other types of dairy products (e.g. cheese). The study consists of four diet phases: fat-free milk phase, full-fat milk phase, fat-free yogurt phase and full-fat yogurt phase. Each diet phase is 3 weeks in duration, separated by a 2 week break. Participants will be provided with 2 servings of a dairy based food item per day specific to their assigned phase and asked to consume them at two separate times during the day - morning and evening. Weight, waist circumference and blood pressure will be measured, blood and stool samples will be collected, and participants will complete two 24-hr food recall questionnaires during each phase. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
| Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
| Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
| Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
| Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
| Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
| Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
| Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
| Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
| Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
| Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
| Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
| Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
| Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A |