NCT02285231

Brief Summary

In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.

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 Nov 2013

Shorter than P25 for not_applicable

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

November 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

November 4, 2014

Last Update Submit

November 5, 2014

Conditions

Pre-diabetes

Keywords

Anti-hyperglycemic effect

Outcome Measures

Primary Outcomes (1)

  • 2-h oral glucose tolerance tests (OGTTs

    6 week

Study Arms (2)

TEST

EXPERIMENTAL

Arginyl-fructose Supplementation

Dietary Supplement: Arginyl-fructose

Placebo

EXPERIMENTAL

Placebo Supplementation

Dietary Supplement: Placebo

Interventions

Arginyl-fructoseDIETARY_SUPPLEMENT
TEST
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

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

You may qualify if:

  • \- All subjects are 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Park SE, Kim OH, Kwak JH, Lee KH, Kwon YI, Chung KH, Lee JH. Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial. Trials. 2015 Nov 14;16:521. doi: 10.1186/s13063-015-1036-z.

    PMID: 26578409DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

fructosyl arginine

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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
PRINCIPAL INVESTIGATOR
PI Title
National Research Laboratory for Clinical Nutrigenetics/Nutrigenomics

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 6, 2014

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

November 6, 2014

Record last verified: 2014-11