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

Yonsei University

Status: Completed

Conditions: Prediabetes; Newly Diagnosed Type 2 Diabetes

Treatments: Dietary Supplement: jerusalem artichoke and fermented soybeans powder mixture; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02506582

AS_DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

jerusalem artichoke and fermented soybeans powder mixture supplementation

Treatment:

Dietary Supplement: jerusalem artichoke and fermented soybeans powder mixture

Placebo group

Placebo Comparator group

Description:

placebo supplementation

Treatment:

Dietary Supplement: placebo