Focus of Study: Oral Tolerance Test With Glucose, Lactose, SucroseNCT01789307
Lactose, Sucrose & Corn Syrup Tolerance
A study testing corn syrup solids and sucrose in people with Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose, run by University of British Columbia at 1 site in Canada.
Trial summary
Lactose, one of the key nutrients in human milk may be critically important to infants for more reasons than being a source of energy. We are interested in understanding how lactose when compared to other sugars influences how nutrients, specifically macronutrients are handled after digestion and absorption. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose
- What is being tested?
- corn syrup solids and sucrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jun 2013
- 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 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- at least 19 years of age
- body mass index (BMI) between 18.5 and 25
- fasting blood glucose level < 6.1 mmol/L (110 mg/dL) measured by glucometer on the day of the study and
- comfortable speaking, reading and understanding English
- comfortable drinking at least one cup (250 ml) of milk
- non-smoking
Who cannot join
- not willing to provide blood samples, have
- impaired lactose or glucose tolerance,
- pre-diabetes, diabetes mellitus and any other endocrine disorder,
- coronary heart disease, liver function test abnormalities or any chronic disease
- routinely take medications, including aspirin, cyclooxygenase-2 inhibitors, statins and fish oil
- consuming more than 1 alcoholic drink per day
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child & Family Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Lactose: A Unique Carbohydrate Enabling Homeostatic Regulation of Blood Glucose & Insulin
Lactose, one of the key nutrients in human milk may be critically important to infants for more reasons than being a source of energy. We are interested in understanding how lactose when compared to other sugars influences how nutrients, specifically macronutrients are handled after digestion and absorption. To date, there have been no studies looking at how fat and protein varies when lactose compared to other sugars is ingested. There may be metabolic advantages to considering lactose for nutrition support of premature infants rather than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in lactose-free formulas. We hope the information from this study will provide new information on the unique aspects of lactose.
Hypothesis: The hypothesis is that providing carbohydrate as lactose:
- minimizes the amount of carbohydrate that is converted into fat
- enables a relatively constant metabolic state throughout feeding interval that avoids swings of high to low insulin, glucose, and fats.
- Being tested
- corn syrup solids, sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corn syrup solidsDietary supplement
Also called corn syrup
oral ingestion 50 grams, 2 doses
sucroseDietary supplement
oral ingestion 50 grams, 2 doses
| Study group | Role | What they receive |
|---|---|---|
| corn syrup solids | Active comparator | corn syrup solids oral ingestion Receives: Dietary Supplement: corn syrup solids |
| sucrose | Experimental | sucrose oral ingestion Receives: Dietary Supplement: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial changes in plasma insulin, glucagon, triglycerides and amino acids.
Area under the curve changes in the outcome measures following oral ingestion.
Measured: 6 hours
Secondary outcomes (1)
Postprandial changes in plasma fatty acids.
Area under the curve analyses of changes in plasma fatty acids following oral ingestion
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Oral Tolerance Test With Glucose, Lactose, SucroseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheila M Innis, PhD, Principal investigator, University of British Columbia, Child & Family Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789307
- Sponsor's protocol ID
- H12-01647
- Status last verified
- Jul 2014
- First submitted
- 20 Dec 2012
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactose: A Unique Carbohydrate Enabling Homeostatic Regulation of Blood Glucose & Insulin
- ClinicalTrials.gov ID
- NCT01789307
- Acronym / sponsor ID
- H12-01647
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Feb 2013 (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.
Lactose, one of the key nutrients in human milk may be critically important to infants for more reasons than being a source of energy. We are interested in understanding how lactose when compared to other sugars influences how nutrients, specifically macronutrients are handled after digestion and absorption. To date, there have been no studies looking at how fat and protein varies when lactose compared to other sugars is ingested. There may be metabolic advantages to considering lactose for nutrition support of premature infants rather than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in lactose-free formulas. We hope the information from this study will provide new information on the unique aspects of lactose.
Hypothesis: The hypothesis is that providing carbohydrate as lactose:
- minimizes the amount of carbohydrate that is converted into fat
- enables a relatively constant metabolic state throughout feeding interval that avoids swings of high to low insulin, glucose, and fats.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corn syrup solids | Active comparator | Dietary Supplement: corn syrup solidscorn syrup solids oral ingestion |
| sucrose | Experimental | Dietary Supplement: sucrosesucrose oral ingestion |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male
- at least 19 years of age
- body mass index (BMI) between 18.5 and 25
- fasting blood glucose level < 6.1 mmol/L (110 mg/dL) measured by glucometer on the day of the study and
- comfortable speaking, reading and understanding English
Key exclusion criteria (6 listed)
- not willing to provide blood samples, have
- impaired lactose or glucose tolerance,
- pre-diabetes, diabetes mellitus and any other endocrine disorder,
- coronary heart disease, liver function test abnormalities or any chronic disease
- routinely take medications, including aspirin, cyclooxygenase-2 inhibitors, statins and fish oil
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 |
|---|---|---|
| corn syrup solidsAlso: corn syruporal ingestion 50 grams, 2 doses | Dietary supplement | corn syrup solids |
| sucroseoral ingestion 50 grams, 2 doses | Dietary supplement | sucrose |
Primary outcome
Postprandial changes in plasma insulin, glucagon, triglycerides and amino acids.
Time frame: 6 hours
Area under the curve changes in the outcome measures following oral ingestion.
1 secondary outcome
Postprandial changes in plasma fatty acids.
Time frame: 6 hours
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 Apr 2026.
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.
Sheila M Innis, PhD principal investigator
University of British Columbia, Child & Family Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corn syrup solids and sucrose in people with Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose, run by University of British Columbia at 1 site in Canada.
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 6 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 Apr 2026. 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 Canada. 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?
Postprandial changes in plasma insulin, glucagon, triglycerides and amino acids. (time frame: 6 hours). It is what the study was designed to measure, not a finding.
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 13 Apr 2026.