NCT02634216

Brief Summary

The purpose of this 12 week longitudinal study is to test the effect of the dietary supplement, Capros, on blood glycemic index of Type 1 diabetics that have a sensor that provides continuous glucose monitoring (CGM). 20 Type 1 Diabetics will take the Capros supplement for 12 weeks to determine the effect of blood glycemic index. Capros, is a generally safe dietary supplement currently sold over the counter in the United States. Type 1 diabetes also known as juvenile diabetes is commonly diagnosed in children and young adults. Insulin is converted into energy needed for daily living, and with diabetes, insulin is not produced in the body as it should causing many problems. In traditional Indian medicine, the gooseberry Phyllanthus emblica has been used for thousands of years as an effective source of polyphenols and antioxidants. A 12 week longitudinal study to determine the effect of the dietary supplement, Capros, on the blood glycemic index in patients with Type 1 diabetes (T1D).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2016

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

June 26, 2015

Last Update Submit

November 18, 2019

Conditions

Type I Diabetes

Keywords

HyperglycemiaCaprosType 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Effect of Capros on Blood Glycemic Index

    To determine the effect on blood glycemic index in Type 1 Diabetics with taking the nutritional supplement Capros

    12 weeks

Study Arms (1)

Type 1 Diabetics using CGM

EXPERIMENTAL

Type 1 diabetics using Continuous Glucose MonitoringCGM to take 500 mg daily of Capros supplement (250 mg twice a day) at lunch and dinner.

Dietary Supplement: Capros

Interventions

CaprosDIETARY_SUPPLEMENT

250 mg BID

Type 1 Diabetics using CGM

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects must be 10 - 60 yrs. of age
  • Type 1 Diabetes using Continuous Glucose Monitoring (CGM) for at least the last 3 months
  • Less than 10% variation in prescribed long acting dosages in the previous 3 months

You may not qualify if:

  • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. informed consent will be excluded from the study
  • Females who are pregnant
  • Individuals who are therapeutically immuno-compromised
  • Prisoners
  • Anyone with a known allergy to amla fruit
  • Steroids (Prednisone, etc.)
  • Immunosuppressants
  • Accutane (last 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Carepoint East 543 Taylor Ave.

Columbus, Ohio, 43203, United States

Location

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, 43210, United States

Location

Davis Heart and Lung Research Institute

Columbus, Ohio, 43212, United States

Location

Related Publications (2)

  • Hiraganahalli BD, Chinampudur VC, Dethe S, Mundkinajeddu D, Pandre MK, Balachandran J, Agarwal A. Hepatoprotective and antioxidant activity of standardized herbal extracts. Pharmacogn Mag. 2012 Apr;8(30):116-23. doi: 10.4103/0973-1296.96553.

    PMID: 22701284RESULT

  • Sabu MC, Kuttan R. Anti-diabetic activity of medicinal plants and its relationship with their antioxidant property. J Ethnopharmacol. 2002 Jul;81(2):155-60. doi: 10.1016/s0378-8741(02)00034-x.

    PMID: 12065146RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Gayle M. Gordillo, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

December 17, 2015

Study Start

January 1, 2015

Primary Completion

May 25, 2016

Study Completion

May 25, 2016

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations

US(3)