Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-06-20

Brief Summary

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The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of HA35.

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Detailed Description

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Conditions

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Gastrointestinal Microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Controls ages 18-45 with BMI of 19-25 or 30-35

Single Arm study

Group Type OTHER

Hyaluronan

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Hyaluronan

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI 19-25 (lean), and BMI 30-35 (obese)
* Age 18-45 years old
* Willingness to take oral supplement and adhere to study requirements

Exclusion Criteria

* Diabetes
* Oral antibiotics within 4 weeks of study initiation
* History of cardiac disease, and medications for cardiac disease
* Use statins and antihypertensive drugs
* Inflammatory bowel disease including irritable bowel syndrome
* History of intestinal surgery, excluding hernia repair and appendectomy
* Active cancer diagnosis (except skin cancer)
* Chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
* Immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
* Vegetarian or vegan diet7
* Abnormal liver or kidney function as measured by routine serum chemistry testing
* Severe anemia or significant white blood cell or platelet abnormalities
* No additional blood or blood product donations during the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes