Acute Probiotic Supplementation and Endothelial Function

NCT04364074 | Completed

• 1 other identifier: 37096
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

One in every two deaths in the United States is caused by cardiovascular disease. Despite strong mechanistic links established between a diet rich in lipids and the pathogenesis of cardiovascular disease, therapeutic advances have focused on reduction in either ingestion or synthesis of cholesterol, and reduction in dietary trans and saturated fatty acids and triglycerides. Even in the setting of aggressive high potency statin therapy and global cardiovascular risk reduction efforts, most clinical trials reveal a significant residual cardiovascular risk with, at best, only 30% reduction in major adverse cardiovascular events. There exists a significant unmet clinical need for identifying novel therapies for the prevention and treatment of cardiovascular disease. This requires identification of additional contributory processes to cardiovascular disease pathogenesis, so that mechanism-based interventions may be developed. Endothelial dysfunction is a pathological state in which there is systemic inflammation of vascular endothelium with consequent expression of pro-vasoconstrictive mediators, thrombotic and atherogenic tendencies. Endothelial dysfunction precedes the development of atherosclerosis and portends an increased risk of future adverse cardiovascular events. Endothelial dysfunction, therefore, can serve as a "barometer" of future cardiovascular risk. Measurement of Flow-mediated dilation ( FMD) is widely accepted as a method to assess vascular endothelial function.

Conditions

Coronary Artery Disease; Hypertension; Hyperlipidemias; Peripheral Vascular Diseases; Cerebral Arterial Diseases

Outcome Measures

Primary Outcomes (1)

• change in baseline flow mediated dilation (FMD) after probiotic consumption

  This is a measurement of endothelial function in the brachial artery

  from baseline to 24 hours after consumption and approximately 7 days after consumption

Secondary Outcomes (3)

• Interleukin-6

  from baseline to 24 hours after consumption and approximately 7 days after consumption

• Interleukin-8

  from baseline to 24 hours after consumption and approximately 7 days after consumption

• Interleukin-12

  from baseline to 24 hours after consumption and approximately 7 days after consumption

Study Arms (2)

GoodBelly Probiotic

EXPERIMENTAL

Subjects randomized to this arm consume one serving of the Goodbelly lactobacillus plantarum 299v probiotic

Dietary Supplement: Goodbelly

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm consume one serving of the Goodbelly that does not contain lactobacillus plantarum 299v

Dietary Supplement: Placebo

Interventions

Goodbelly DIETARY_SUPPLEMENT

Consumption of 1 serving of Goodbelly probiotic daily for 6 weeks. This will be followed by an observation period for 6 weeks during which the subjects will not consume Goodbelly.

Also known as: Goodbelly probiotic

GoodBelly Probiotic

Placebo DIETARY_SUPPLEMENT

To prepare the placebo, the dietitian will first heat a water bath to 80 degrees Celsius. This removes the lactobacillus plantarum 299v from the probiotic drink

Also known as: Goodbelly Probitoic

Placebo

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least one of the following conditions:
• Hypertension
• Hyperlipidemia
• Diabetes mellitus (Type 1 or Type 2)
• Peripheral vascular disease
• Cerebrovascular disease
• Cardiovascular disease.

You may not qualify if:

• Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
• LV dysfunction as defined by an LV ejection fraction documented as \< 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
• Uncontrolled hypertension with blood pressure greater than 170/100 mmHg at the screening visit.
• Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
• Known history of cognitive impairment or inability to follow study procedures
• Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
• Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
• Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment.
• Pregnancy
• Patients who are currently taking Vitamin K antagonists such as coumadin, warfarin.
• Those who are daily drinkers.
• Patients with gastrointestinal diseases that might alter the impact of a probiotic (e.g. status post colectomy, short gut syndrome, or inflammatory bowel disease)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53222, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hypertension; Hyperlipidemias; Peripheral Vascular Diseases; Cerebral Arterial Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 27, 2020
• Study Start: August 17, 2020
• Primary Completion: September 22, 2022
• Study Completion: August 3, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

US (1)