NCT02506582

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

May 6, 2015

Last Update Submit

July 22, 2015

Conditions

PrediabetesNewly Diagnosed Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)

    12 week

Study Arms (2)

Test group

EXPERIMENTAL

jerusalem artichoke and fermented soybeans powder mixture supplementation

Dietary Supplement: jerusalem artichoke and fermented soybeans powder mixture

Placebo group

PLACEBO COMPARATOR

placebo supplementation

Dietary Supplement: placebo

Interventions

jerusalem artichoke and fermented soybeans powder mixtureDIETARY_SUPPLEMENT

40 g jerusalem artichoke and fermented soybean powder mixture

Test group
placeboDIETARY_SUPPLEMENT

40 g powdered rice flour

Placebo group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jong Ho Lee, PhD

    Yonsei University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

July 23, 2015

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07