Effect of Prebiotics on Blood Pressure Management

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05364736
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 98.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood pressure, gut microbiota and cardiovascular risk fators in subjects with hypertention.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Gastrointestinal Microbiome	Dietary Supplement: Highland barley β-glucan dietary supplement; Other: Placebo controls	N/A

Detailed Description

Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. However, its protective role in subjects with hypertension are remain unclear. This study aims to examine the effect of 12-week prebiotics supplementation on blood pressure management in subjects with hypertension. By understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: placebo-controlled, randomized clinical trialplacebo-controlled, randomized clinical trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
• Primary Purpose: Prevention
• Official Title: An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
• Anticipated Study Start Date: Oct 17, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Highland barley β-glucan group Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations.	Dietary Supplement: Highland barley β-glucan dietary supplement; 100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
Placebo Comparator: Placebo group Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations.	Other: Placebo controls; Placebo with a similar appearance and taste to highland barley β-glucan supplement

Outcome Measures

Primary Outcome Measures

1. changes of systolic blood pressure [baseline and 12 weeks]

   changes of systolic blood pressure

2. changes of diastolic blood pressure [baseline and 12 weeks]

   changes of diastolic blood pressure

3. changes of gut microbiota [baseline and 12 weeks]

   changes of gut microbiota by metagenomics

Secondary Outcome Measures

1. gut microbiota [baseline and 12 weeks]

   changes of gut microbiota by metagenomics

2. pulse wave velocity [baseline and 12 weeks]

   changes of pulse wave velocity by VP-1000plus from Omron

3. ankle Brachial Index [baseline and 12 weeks]

   changes of ankle Brachial Index by VP-1000plus from Omron

4. microbial metabolite [baseline and 12 weeks]

   changes of microbial metabolite by untargeted metabolomics

5. central aortic pressure [baseline and 12 weeks]

   changes of central aortic pressure by VICORDER Complete Vascular Laboratory

6. flow-mediated dilation [baseline and 12 weeks]

   changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory

7. carotid-femoral pulse wave velocity [baseline and 12 weeks]

   changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age:30-65 years old

2. Newly diagnosed hypertension did not use antihypertensive drugs OR Systolic blood pressure ≥140mmHg on the physical examination OR Diastolic blood pressure ≥90mmHg on the physical examination.

3. BMI≥18 kg/m2

Exclusion Criteria:

1. Receiving or have been treated with antihypertensive drugs.

2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.

3. Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR<30ml/min/1.73m2).

4. Autoimmune diseases or thyroid diseases.

5. Women who are pregnant, nursing, or prepare to give birth during the trail.

6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease.

7. Mental or intellectual abnormalities, unable to sign informed consent.

8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.

9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.

10. Major operations were performed within six months of screening visit, or will be made during the trial.

11. Alcohol abuse (alcohol intake>60g/d for male and alcohol intake>40g/d for female)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Min Xia, PhD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Min Xia, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05364736
• Other Study ID Numbers: 2020HBβG-H
• First Posted: May 6, 2022
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Min Xia, Professor, Sun Yat-sen University: Hypertension; Gastrointestinal Microbiome; Prebiotics
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of May 6, 2022