Lactose, Sucrose & Corn Syrup Tolerance

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

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

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

Intervention / Treatment
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* Dietary Supplement: corn syrup solids
* Dietary Supplement: sucrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: corn syrup solids<br>corn syrup solids oral ingestion | Dietary Supplement: corn syrup solids<br>* oral ingestion 50 grams, 2 doses<br>* Other names: corn syrup;|
| Experimental: sucrose<br>sucrose oral ingestion | Dietary Supplement: sucrose<br>* oral ingestion 50 grams, 2 doses<br>|

What is the study measuring?
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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 |