NCT01789307

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 13, 2026

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

December 20, 2012

Last Update Submit

April 8, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Postprandial changes in plasma fatty acids.

    6 hours

Study Arms (2)

corn syrup solids

ACTIVE COMPARATOR

corn syrup solids oral ingestion

Dietary Supplement: corn syrup solids

sucrose

EXPERIMENTAL

sucrose oral ingestion

Dietary Supplement: sucrose

Interventions

corn syrup solidsDIETARY_SUPPLEMENT

oral ingestion 50 grams, 2 doses

Also known as: corn syrup
corn syrup solids
sucroseDIETARY_SUPPLEMENT

oral ingestion 50 grams, 2 doses

sucrose

Eligibility Criteria

Age19 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child & Family Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

MeSH Terms

Interventions

High Fructose Corn SyrupSucrose

Intervention Hierarchy (Ancestors)

Dietary SugarsDietary CarbohydratesCarbohydratesSugarsNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDisaccharidesOligosaccharidesPolysaccharides

Study Officials

  • Sheila M Innis, PhD

    University of British Columbia, Child & Family Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2012

First Posted

February 12, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 13, 2026

Record last verified: 2014-07

Locations

CA(1)