The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients

Huazhong University of Science and Technology

Status: Unknown

Conditions: Pre-diabetic

Treatments: Other: Placebo; Dietary Supplement: Yeast Beta-glucan

Study type: Interventional

Funder types: Other

Identifiers

NCT03495362

CHW20180201

Details and patient eligibility

About

There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. This is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. Firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18-65 years
• Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999

Exclusion criteria

• Allergic to test substances
• Known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases
• Known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently
• Usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks
• Unable to cooperate with researchers or maintain ordinary dietary habit

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Ingredients: yeast beta-glucan, and capsule shell Capsule, per capsule with 500mg insoluble beta-glucan, twice a day, 1 capsule each time. The intervention period is about 3 months.

Treatment:

Dietary Supplement: Yeast Beta-glucan

Placebo group

Placebo Comparator group

Description:

Ingredients: starch, and capsule shell Capsule, per capsule with 500mg starch, twice a day, 1 capsule each time. The intervention period is about 3 months.

Treatment:

Other: Placebo