Lactose, Sucrose & Corn Syrup Tolerance

Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose Clinical Trial

Official title:

Lactose: A Unique Carbohydrate Enabling Homeostatic Regulation of Blood Glucose & Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789307
• Other study ID #: H12-01647
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: July 3, 2014
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose

Intervention

Dietary Supplement:
• corn syrup solids
oral ingestion 50 grams, 2 doses
• sucrose
oral ingestion 50 grams, 2 doses

Locations

Country	Name	City	State
Canada	Child & Family Research Institute	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial changes in plasma insulin, glucagon, triglycerides and amino acids.	Area under the curve changes in the outcome measures following oral ingestion.	6 hours	No
Secondary	Postprandial changes in plasma fatty acids.	Area under the curve analyses of changes in plasma fatty acids following oral ingestion	6 hours	No