Effect of Galactose Ingestion on Postprandial Lipemia

The Acute Effects of Galactose Ingestion on Oral Fat Tolerance

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.

Study Overview

• Status: Completed
• Conditions: Lipemia; Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Galactose; Dietary supplement: Glucose

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bath, United Kingdom, BA2 7AY
    • Department for Health, University of Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Galactose; 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; Co-ingestion of d-galactose with a high-fat meal
ACTIVE_COMPARATOR: Glucose; 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; Co-ingestion of d-glucose with a high-fat meal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bath

Publications and helpful links

General Publications

• Watkins J, Simpson A, Betts JA, Thompson D, Holliday A, Deighton K, Gonzalez JT. Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men. J Nutr. 2020 Jul 1;150(7):1765-1772. doi: 10.1093/jn/nxaa105.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: MSES 16/17-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Raw data will be made available online upon publication in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No