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

Not Applicable

Completed

• Conditions: Newly Diagnosed Type 2 Diabetes; Prediabetes
• Interventions: Dietary Supplement: placebo; Dietary Supplement: jerusalem artichoke and fermented soybeans powder mixture

• Registration Number: NCT02506582
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Study First Submitted: 2015-05-06
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-22
• Last Update Submitted: 2015-07-22
• Study First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

1. glucose lowering medications or insulin injections;
2. abnormal liver or renal function;
3. chronic stomach and intestines disease;
4. chronic alcoholism;
5. pregnancy or intending to become pregnant during time of study.
6. complications;
7. an occupation that could be dangerous if hypoglycemia should occur.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo	placebo supplementation
Test group	jerusalem artichoke and fermented soybeans powder mixture	jerusalem artichoke and fermented soybeans powder mixture supplementation

Primary Outcome Measures

Name	Time	Method
Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)	12 week