Lactose, Sucrose & Corn Syrup Tolerance

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:

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.

Study Overview

• Status: Completed
• Conditions: Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose
• Intervention / Treatment: Dietary supplement: corn syrup solids; Dietary supplement: sucrose

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4H4
      • Child & Family Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: corn syrup
Experimental: sucrose; sucrose oral ingestion	Dietary supplement: sucrose; oral ingestion 50 grams, 2 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial changes in plasma insulin, glucagon, triglycerides and amino acids.	Area under the curve changes in the outcome measures following oral ingestion.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial changes in plasma fatty acids.	Area under the curve analyses of changes in plasma fatty acids following oral ingestion	6 hours

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Sheila M Innis, PhD, University of British Columbia, Child & Family Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Estimate): July 4, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: H12-01647