Effect of Galactose Ingestion on Postprandial Lipemia

Cardiovascular Risk Factor Clinical Trial

Official title:

The Acute Effects of Galactose Ingestion on Oral Fat Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439878
• Other study ID #: MSES 16/17-011
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hyperlipidemias
• Lipemia

Intervention

Dietary Supplement:
• Galactose
Co-ingestion of d-galactose with a high-fat meal
• Glucose
Co-ingestion of d-glucose with a high-fat meal

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial increase plasma triglyceride concentrations	Incremental area under the curve (iAUC) of plasma triglyceride concentrations	5 hours
Secondary	Postprandial plasma insulin concentrations	Incremental area under the curve (iAUC) of plasma insulin concentrations	5 hours
Secondary	Postprandial plasma glucose concentrations	Incremental area under the curve (iAUC) of plasma glucose concentrations	5 hours
Secondary	Postprandial plasma non-esterified fatty acid concentrations	Postprandial area under the curve of non-esterified fatty acid concentrations	5 hours
Secondary	Postprandial plasma lactate concentrations	Incremental area under the curve (iAUC) of plasma lactate concentrations	5 hours
Secondary	Postprandial subjective hunger ratings	Postprandial area under the curve of hunger ratings measured by visual analogue scales (0-100 mm)	5 hours
Secondary	Postprandial subjective fullness ratings	Postprandial area under the curve of fullness ratings measured by visual analogue scales (0-100 mm)	5 hours
Secondary	Postprandial subjective satisfaction ratings	Postprandial area under the curve of satisfaction ratings measured by visual analogue scales (0-100 mm)	5 hours
Secondary	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
Secondary	Postprandial overall appetite ratings	Postprandial area under the curve of overall appetite ratings measured by visual analogue scales (0-100 mm)	5 hours