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Trial record 85 of 1009 for:    Area Under Curve AND insulin

Lactose, Sucrose & Corn Syrup Tolerance

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ClinicalTrials.gov Identifier: NCT01789307
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief 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. 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:

  1. minimizes the amount of carbohydrate that is converted into fat
  2. enables a relatively constant metabolic state throughout feeding interval that avoids swings of high to low insulin, glucose, and fats.

Condition or disease Intervention/treatment Phase
Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose Dietary Supplement: corn syrup solids Dietary Supplement: sucrose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Lactose: A Unique Carbohydrate Enabling Homeostatic Regulation of Blood Glucose & Insulin
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Active Comparator: corn syrup solids
corn syrup solids oral ingestion
Dietary Supplement: corn syrup solids
oral ingestion 50 grams, 2 doses
Other Name: corn syrup

Experimental: sucrose
sucrose oral ingestion
Dietary Supplement: sucrose
oral ingestion 50 grams, 2 doses




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Postprandial changes in plasma fatty acids. [ Time Frame: 6 hours ]
    Area under the curve analyses of changes in plasma fatty acids following oral ingestion



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789307


Locations
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Canada, British Columbia
Child & Family Research Institute
Vancouver, British Columbia, Canada, V5Z4H4
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Sheila M Innis, PhD University of British Columbia, Child & Family Research Institute

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01789307     History of Changes
Other Study ID Numbers: H12-01647
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: July 2014