Type I DiabetesCarposT1DNCT02634216
Effects of Capros in Patients With Type-1 Diabetes
A study testing Capros in people with Type I Diabetes, run by Ohio State University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Capros
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to 25 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
- Current use of any of the following medications will result in exclusion:
Show all 9Show fewer
- Steroids (Prednisone, etc.)
- Immunosuppressants
- Accutane (last 6 months)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carepoint East 543 Taylor Ave.
Columbus, Ohio, 43203
Martha Morehouse Medical Plaza 2050 Kenny Road
Columbus, Ohio, 43210
Davis Heart and Lung Research Institute
Columbus, Ohio, 43212
About this study
Official title: Effects of Capros Supplementation on Hyperglycemia in Patients With Type-1 Diabetes
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).
Read the detailed description
There are a total of 4 study visits,over the course of 12 weeks. These visits will occur on weeks 1, 4, 8, and 12. At each study visit the the following will be recorded: Age, Sex, Pulse, height, weight, CGM real time measurement and the following non-medical information will be recorded: Address, Phone number and Email address ( will be recorded at the first visit and will be asked if anything has changed at the reoccurring visits). The following will happen at each visit:
Visit 1 (Week 0): The subject will be presented with informed consent. Data will be collected on a data collection sheet, a finger stick for A1C will be obtained (if not completed as SoC), Continuous Glucose Monitoring will be downloaded, UPT for WCBP will be performed, the subject will be given a 4-week supply of the Capros supplement and a subject diary. The subject will be given a subject diary to document their morning/evening sugar and the time of when participants take the supplements. The subject will be asked to bring in the diary to each follow-up visit to check for compliance verification.
Visit 2 and 3 (Week 4 and 8): The following activities will take place during these visits: AE review, concomitant medications review, weight, vital signs, CGM download, pill count and distribution, collect previous diary and provide new.
Visit 4 (Week 12): The following activities will take place during these visits: AE review, concomitant medications review, weight, vital signs, CGM download, pill count, collect previous diary. Also, at this visit, a finger stick for A1C (if not completed as SoC), no further distribution of supplements.
Taking the supplement: After receiving the supplement, the subject is instructed to take 2 capsules per day by mouth, once with food around lunchtime and once with food around dinner time for a total of 12 weeks. The subjects will be asked to keep all empty bottles/ any remaining Capros supplements and bring them to each follow-up visit for a compliance check. Participants will receive a new 4-week supply of supplements at study visits 2 and 3.
Risks for participating in this study are extremely low. Capros is a dietary supplement derived from the Indian Gooseberry, and contains no artificial ingredients, is non-toxic and is safely tolerated among humans. Capros is currently sold over the counter in the U.S. and has no known side effects; however an allergic reaction to the supplement is possible.
There is a potential risk for hypoglycemia while taking this supplement. In the even that this occurs, subjects are instructed to follow their primary care physician instructions for this and record it on their data log.
This is not a treatment study so subjects may have no direct benefit while taking the supplement. The investigators are looking to monitor and observe if any changes take place with participants blood sugar level over the course of the study.
- Conditions
- Type I Diabetes
- Being tested
- Capros
- Keywords
- Hyperglycemia, Capros, Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaprosDietary supplement
250 mg BID
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Capros |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2015
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Natreon, Inc.
- Responsible party
- Sponsor
- Investigators
- Gayle M. Gordillo, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634216
- Sponsor's protocol ID
- 2014H0206
- Acronym
- CarposT1D
- Status last verified
- Nov 2019
- First submitted
- 26 Jun 2015
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22701284Sabu 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.
PubMed 12065146
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Capros Supplementation on Hyperglycemia in Patients With Type-1 Diabetes
- ClinicalTrials.gov ID
- NCT02634216
- Acronym / sponsor ID
- CarposT1D / 2014H0206
- Conditions
- Type I Diabetes
- Keywords
- Hyperglycemia, Capros, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Natreon, Inc.
- Study start
- Jan 2015
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
There are a total of 4 study visits,over the course of 12 weeks. These visits will occur on weeks 1, 4, 8, and 12. At each study visit the the following will be recorded: Age, Sex, Pulse, height, weight, CGM real time measurement and the following non-medical information will be recorded: Address, Phone number and Email address ( will be recorded at the first visit and will be asked if anything has changed at the reoccurring visits). The following will happen at each visit:
Visit 1 (Week 0): The subject will be presented with informed consent. Data will be collected on a data collection sheet, a finger stick for A1C will be obtained (if not completed as SoC), Continuous Glucose Monitoring will be downloaded, UPT for WCBP will be performed, the subject will be given a 4-week supply of the Capros supplement and a subject diary. The subject will be given a subject diary to document their morning/evening sugar and the time of when participants take the supplements. The subject will be asked to bring in the diary to each follow-up visit to check for compliance verification.
Visit 2 and 3 (Week 4 and 8): The following activities will take place during these visits: AE review, concomitant medications review, weight, vital signs, CGM download, pill count and distribution, collect previous diary and provide new.
Visit 4 (Week 12): The following activities will take place during these visits: AE review, concomitant medications review, weight, vital signs, CGM download, pill count, collect previous diary. Also, at this visit, a finger stick for A1C (if not completed as SoC), no further distribution of supplements.
Taking the supplement: After receiving the supplement, the subject is instructed to take 2 capsules per day by mouth, once with food around lunchtime and once with food around dinner time for a total of 12 weeks. The subjects will be asked to keep all empty bottles/ any remaining Capros supplements and bring them to each follow-up visit for a compliance check. Participants will receive a new 4-week supply of supplements at study visits 2 and 3.
Risks for participating in this study are extremely low. Capros is a dietary supplement derived from the Indian Gooseberry, and contains no artificial ingredients, is non-toxic and is safely tolerated among humans. Capros is currently sold over the counter in the U.S. and has no known side effects; however an allergic reaction to the supplement is possible.
There is a potential risk for hypoglycemia while taking this supplement. In the even that this occurs, subjects are instructed to follow their primary care physician instructions for this and record it on their data log.
This is not a treatment study so subjects may have no direct benefit while taking the supplement. The investigators are looking to monitor and observe if any changes take place with participants blood sugar level over the course of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetics using CGM | Experimental | Dietary Supplement: CaprosType 1 diabetics using Continuous Glucose MonitoringCGM to take 500 mg daily of Capros supplement (250 mg twice a day) at lunch and dinner. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capros250 mg BID | Dietary supplement | Type 1 Diabetics using CGM |
Primary outcome
Effect of Capros on Blood Glycemic Index
Time frame: 12 weeks
To determine the effect on blood glycemic index in Type 1 Diabetics with taking the nutritional supplement Capros
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Results publication: PubMed 22701284Hiraganahalli 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.
- Results publication: PubMed 12065146Sabu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle M. Gordillo, M.D. principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capros in people with Type I Diabetes, run by Ohio State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Capros on Blood Glycemic Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634216, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.