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

Completed · Not applicable

Conditions studied: Gastrointestinal Microbiome

In brief

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.

Key facts

Study ID

NCT02867605

Run by

The Cleveland Clinic

People needed

20

Starts

2016-07-01

Expected to finish

2019-06-20

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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