Effect of Galactose Ingestion on Postprandial Lipemia

Study Overview
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Brief Summary
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This study aims to assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose.

Official Title
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The Acute Effects of Galactose Ingestion on Oral Fat Tolerance

Conditions
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Cardiovascular Risk Factor, Lipemia

Intervention / Treatment
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* Dietary Supplement: Galactose
* Dietary Supplement: Glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18 to 35 years old Body mass index <30 kg/m2 Exclusion Criteria: Female Body mass index >29.9 kg/m2 Any history of metabolic disease Allergies or intolerances to milk and/or cream

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, blinded crossover design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galactose<br>Ingestion of 0.75 g/kg body mass of d-galactose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat. | Dietary Supplement: Galactose<br>* Co-ingestion of d-galactose with a high-fat meal<br>|
| Active Comparator: Glucose<br>Ingestion of 0.75 g/kg body mass of dextrose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat. | Dietary Supplement: Glucose<br>* Co-ingestion of d-glucose with a high-fat meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial increase plasma triglyceride concentrations | Incremental area under the curve (iAUC) of plasma triglyceride concentrations | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial plasma insulin concentrations | Incremental area under the curve (iAUC) of plasma insulin concentrations | 5 hours | 
| Postprandial plasma glucose concentrations | Incremental area under the curve (iAUC) of plasma glucose concentrations | 5 hours | 
| Postprandial plasma non-esterified fatty acid concentrations | Postprandial area under the curve of non-esterified fatty acid concentrations | 5 hours | 
| Postprandial plasma lactate concentrations | Incremental area under the curve (iAUC) of plasma lactate concentrations | 5 hours | 
| Postprandial subjective hunger ratings | Postprandial area under the curve of hunger ratings measured by visual analogue scales (0-100 mm) | 5 hours | 
| Postprandial subjective fullness ratings | Postprandial area under the curve of fullness ratings measured by visual analogue scales (0-100 mm) | 5 hours | 
| Postprandial subjective satisfaction ratings | Postprandial area under the curve of satisfaction ratings measured by visual analogue scales (0-100 mm) | 5 hours | 
| Postprandial prospective food consumption ratings | Postprandial area under the curve of prospective food consumption ratings measured by visual analogue scales (0-100 mm) | 5 hours | 
| Postprandial overall appetite ratings | Postprandial area under the curve of overall appetite ratings measured by visual analogue scales (0-100 mm) | 5 hours |