Pre-diabetesL-ArabinoseNCT01107431
Effects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin
A study testing L-Arabinose and Chromium and Sucrose without dietary Supplement in people with Pre-diabetes, run by Integrative Health Technologies, Inc. at 1 site in United States.
Trial summary
This study was designed to examine changes in capillary blood glucose and venous insulin levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- L-Arabinose and Chromium and Sucrose without dietary Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All study subjects were required to contact their family physician to ensure they had no medical conditions that would preclude their participation.
Who cannot join
- Diabetics, and
- Those not approved by their physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Health Technologies
San Antonio, Texas, 78209
About this study
Official title: A Combination of L-Arabinose and Chromium Lowers Circulating Glucose and Insulin Levels After Acute Oral Sucrose Challenge
This study was designed to examine changes in capillary blood glucose and venous insulin levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr).
Read the detailed description
This study concluded that consumption of the LA-Cr supplement in conjunction with a 70-gram sucrose challenge led to a significant reduction of capillary blood glucose and venous insulin as compared to the sucrose challenge without the LA-Cr supplement. This finding may provide an important tool to reduce the adverse effects associated with elevated glucose and insulin levels.
- Conditions
- Pre-diabetes
- Being tested
- L-Arabinose and Chromium, Sucrose without dietary Supplement
- Keywords
- glucose, insulin, L-arabinose, Chromium
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Arabinose and ChromiumDietary supplement
Also called 70 grams of cane sugar along with supplement
Consumed 70 grams of sucrose simultaneously taking a dietary supplement
Sucrose without dietary SupplementDietary supplement
Also called 70 grams of cane sugar with supplement
Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
| Study group | Role | What they receive |
|---|---|---|
| Sucrose with Dietary Supplement | Active comparator | Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium Receives: Dietary Supplement: L-Arabinose and Chromium |
| Sucrose without Dietary Supplement | Active comparator | Consumed 70 grams of sucrose without simultaneously taking the dietary supplement Receives: Dietary Supplement: Sucrose without dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Finger-stick glucose measurements taken every 15 or 30 minutes after taking a 70 gram sucrose challenge with and without the dietary supplement
Measured: Every 15 to 30 minutes
Secondary outcomes (1)
Fasting Blood Insulin Levels
A venipuncture blood test taken 30, 60, 90 and 120 minutes after taking a 70 gram sucrose challenge with and without taking the dietary supplement
Measured: Every 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Health Technologies, Inc.
- Sponsor type
- Research network
- Investigators
- Gilbert R Kaats, PhD, Principal investigator, Integrative Health TechnologiesHarry G Preuss, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107431
- Sponsor's protocol ID
- Pharmachem 40-47
- Acronym
- L-Arabinose
- Status last verified
- May 2011
- First submitted
- 19 Apr 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaats GR, Keith SC, Keith PL, Leckie RB, Perricone NV, Preuss HG. A combination of l-arabinose and chromium lowers circulating glucose and insulin levels after an acute oral sucrose challenge. Nutr J. 2011 May 6;10:42. doi: 10.1186/1475-2891-10-42.
PubMed 21548959
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of L-Arabinose and Chromium Lowers Circulating Glucose and Insulin Levels After Acute Oral Sucrose Challenge
- ClinicalTrials.gov ID
- NCT01107431
- Acronym / sponsor ID
- L-Arabinose / Pharmachem 40-47
- Conditions
- Pre-diabetes
- Keywords
- glucose, insulin, L-arabinose, Chromium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Integrative Health Technologies, Inc.Research network
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Apr 2010 (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.
This study was designed to examine changes in capillary blood glucose and venous insulin levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr).
Detailed description
This study concluded that consumption of the LA-Cr supplement in conjunction with a 70-gram sucrose challenge led to a significant reduction of capillary blood glucose and venous insulin as compared to the sucrose challenge without the LA-Cr supplement. This finding may provide an important tool to reduce the adverse effects associated with elevated glucose and insulin levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose with Dietary Supplement | Active comparator | Dietary Supplement: L-Arabinose and ChromiumRepeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium |
| Sucrose without Dietary Supplement | Active comparator | Dietary Supplement: Sucrose without dietary SupplementConsumed 70 grams of sucrose without simultaneously taking the dietary supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All study subjects were required to contact their family physician to ensure they had no medical conditions that would preclude their participation.
Key exclusion criteria (2 listed)
- Diabetics, and
- Those not approved by their physicians.
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 |
|---|---|---|
| L-Arabinose and ChromiumAlso: 70 grams of cane sugar along with supplementConsumed 70 grams of sucrose simultaneously taking a dietary supplement | Dietary supplement | Sucrose with Dietary Supplement |
| Sucrose without dietary SupplementAlso: 70 grams of cane sugar with supplementRepeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium | Dietary supplement | Sucrose without Dietary Supplement |
Primary outcome
Fasting Blood Glucose
Time frame: Every 15 to 30 minutes
Finger-stick glucose measurements taken every 15 or 30 minutes after taking a 70 gram sucrose challenge with and without the dietary supplement
1 secondary outcome
Fasting Blood Insulin Levels
Time frame: Every 30 minutes
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 13 May 2011.
- Derived from this study: PubMed 21548959Kaats GR, Keith SC, Keith PL, Leckie RB, Perricone NV, Preuss HG. A combination of l-arabinose and chromium lowers circulating glucose and insulin levels after an acute oral sucrose challenge. Nutr J. 2011 May 6;10:42. doi: 10.1186/1475-2891-10-42.
Related trials for Pre-diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Gilbert R Kaats, PhD principal investigator
Integrative Health Technologies
Harry G Preuss, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Arabinose and Chromium and Sucrose without dietary Supplement in people with Pre-diabetes, run by Integrative Health Technologies, Inc. at 1 site 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 1 inclusion and 2 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 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Fasting Blood Glucose (time frame: Every 15 to 30 minutes). 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 NCT01107431, which also lists 1 linked publication.
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 13 May 2011.