Healthy MalesNCT00782392
Bioavailability and Dosing of a Monosaccharide Supplement in Adults
An observational study of Healthy Males, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
We are developing an oral supplement of carbohydrates to be added to infant formulas in order to improve brain development, immune function, and overall health of infants and children. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2007
- Phase
- Observational
- 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 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy Caucasian Males
Who may be able to join
- Caucasian (non-hispanic)
- Male
- Age 18-28
- Regularly eat breakfast
- Healthy
- BMI within normal limits (18.5 - 24.9)
- English speaking
Who cannot join
- History of smoking, more than occasional alcohol use, or drug use.
- Chronic medical diagnosis
- Medications that may interfere with the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Bioavailability and Dosing of an Oral Monosaccharide Supplement in Adults and Effects on Resting Brain Activity
We are developing an oral supplement of carbohydrates to be added to infant formulas in order to improve brain development, immune function, and overall health of infants and children. After a careful review of what is known about these sugars, there is very little information regarding their use in infants and children, although there is some information in adults and animals.
Many of these sugars have been used in a glyco-nutritional supplement in adults and children, with minimal or no reported side effects.
We are developing a custom blend of important individual sugars, and need information regarding their dosing and blood concentrations following oral intake of the carbohydrate supplement. Timed blood samples following the carbohydrate supplement will provide us with a better understanding of the most effective dose and the metabolism of these sugars in adults. This will give us the preliminary information we need for developing an oral supplement of special sugars that can be added to infant formulas to help improve brain development and immune function in infants and children.
- Conditions
- Healthy Males
- Keywords
- Nutrition, Infant Formula
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MalesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782392
- Sponsor's protocol ID
- 45092
- Status last verified
- May 2011
- First submitted
- 29 Oct 2008
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Dosing of an Oral Monosaccharide Supplement in Adults and Effects on Resting Brain Activity
- ClinicalTrials.gov ID
- NCT00782392
- Acronym / sponsor ID
- 45092
- Conditions
- Healthy Males
- Keywords
- Nutrition, Infant Formula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Arkansas, United States Department of Agriculture (USDA)
- Study start
- Jan 2007
- Primary completion
- Jun 2007 (actual)
- First posted
- 31 Oct 2008 (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.
We are developing an oral supplement of carbohydrates to be added to infant formulas in order to improve brain development, immune function, and overall health of infants and children. After a careful review of what is known about these sugars, there is very little information regarding their use in infants and children, although there is some information in adults and animals.
Many of these sugars have been used in a glyco-nutritional supplement in adults and children, with minimal or no reported side effects.
We are developing a custom blend of important individual sugars, and need information regarding their dosing and blood concentrations following oral intake of the carbohydrate supplement. Timed blood samples following the carbohydrate supplement will provide us with a better understanding of the most effective dose and the metabolism of these sugars in adults. This will give us the preliminary information we need for developing an oral supplement of special sugars that can be added to infant formulas to help improve brain development and immune function in infants and children.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Caucasian Males
Key inclusion criteria (7 listed)
- Caucasian (non-hispanic)
- Male
- Age 18-28
- Regularly eat breakfast
- Healthy
Key exclusion criteria (3 listed)
- History of smoking, more than occasional alcohol use, or drug use.
- Chronic medical diagnosis
- Medications that may interfere with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Males, run by Arkansas Children's Hospital Research Institute 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 7 inclusion and 3 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 18 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.
Where can I read the original study information?
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 18 May 2011.