The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control

Study Overview
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Brief Summary
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The purpose of this randomized, double-blind, placebo-controlled study was to determine whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.

Detailed Description
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The objective of this clinical study was to evaluate the effect of jerusalem artichoke and fermented soybean powder mixture supplementation on blood glucose. A randomized, double-blinded, placebo-controlled study was conducted on 60 subjects with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes. The subjects were randomly assigned to either a group ingesting 40 g jerusalem artichoke and fermented soybean powder mixture supplementation daily or a placebo group for 12-week. We assessed fasting and postprandial levels of glucose.

Official Title
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The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control

Conditions
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Prediabetes, Newly Diagnosed Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: jerusalem artichoke and fermented soybeans powder mixture
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All subjects were with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL. Exclusion Criteria: glucose lowering medications or insulin injections; abnormal liver or renal function; chronic stomach and intestines disease; chronic alcoholism; pregnancy or intending to become pregnant during time of study. complications; an occupation that could be dangerous if hypoglycemia should occur.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>jerusalem artichoke and fermented soybeans powder mixture supplementation | Dietary Supplement: jerusalem artichoke and fermented soybeans powder mixture<br>* 40 g jerusalem artichoke and fermented soybean powder mixture<br>|
| Placebo Comparator: Placebo group<br>placebo supplementation | Dietary Supplement: placebo<br>* 40 g powdered rice flour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose level by 2-h oral glucose tolerance tests (OGTTs) |  | 12 week |