Lactose, Sucrose & Corn Syrup Tolerance

NCT ID: NCT01789307

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

corn syrup solids

corn syrup solids oral ingestion

Group Type: ACTIVE_COMPARATOR

corn syrup solids

Intervention Type: DIETARY_SUPPLEMENT

oral ingestion 50 grams, 2 doses

sucrose

sucrose oral ingestion

Group Type: EXPERIMENTAL

sucrose

Intervention Type: DIETARY_SUPPLEMENT

oral ingestion 50 grams, 2 doses

Interventions

corn syrup solids

oral ingestion 50 grams, 2 doses

Intervention Type: DIETARY_SUPPLEMENT

sucrose

oral ingestion 50 grams, 2 doses

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

corn syrup

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila M Innis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, Child & Family Research Institute

Locations

Child & Family Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-01647

Identifier Type: -

Identifier Source: org_study_id