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Effect of Galactose Ingestion on Postprandial Lipemia

Primary Purpose

Cardiovascular Risk Factor, Lipemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Galactose
Glucose
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Risk Factor

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department for Health, University of Bath

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Galactose

Glucose

Arm Description

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.

Ingestion of 0.75 g/kg body mass of dextrose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat.

Outcomes

Primary Outcome Measures

Postprandial increase plasma triglyceride concentrations
Incremental area under the curve (iAUC) of plasma triglyceride concentrations

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2018
Last Updated
May 23, 2018
Sponsor
University of Bath
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1. Study Identification

Unique Protocol Identification Number
NCT03439878
Brief Title
Effect of Galactose Ingestion on Postprandial Lipemia
Official Title
The Acute Effects of Galactose Ingestion on Oral Fat Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Lipemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, blinded crossover design.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and the researchers performing biochemical analyses will be blinded to the intervention.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galactose
Arm Type
Experimental
Arm Description
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.
Arm Title
Glucose
Arm Type
Active Comparator
Arm Description
Ingestion of 0.75 g/kg body mass of dextrose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat.
Intervention Type
Dietary Supplement
Intervention Name(s)
Galactose
Intervention Description
Co-ingestion of d-galactose with a high-fat meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Co-ingestion of d-glucose with a high-fat meal
Primary Outcome Measure Information:
Title
Postprandial increase plasma triglyceride concentrations
Description
Incremental area under the curve (iAUC) of plasma triglyceride concentrations
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Postprandial plasma insulin concentrations
Description
Incremental area under the curve (iAUC) of plasma insulin concentrations
Time Frame
5 hours
Title
Postprandial plasma glucose concentrations
Description
Incremental area under the curve (iAUC) of plasma glucose concentrations
Time Frame
5 hours
Title
Postprandial plasma non-esterified fatty acid concentrations
Description
Postprandial area under the curve of non-esterified fatty acid concentrations
Time Frame
5 hours
Title
Postprandial plasma lactate concentrations
Description
Incremental area under the curve (iAUC) of plasma lactate concentrations
Time Frame
5 hours
Title
Postprandial subjective hunger ratings
Description
Postprandial area under the curve of hunger ratings measured by visual analogue scales (0-100 mm)
Time Frame
5 hours
Title
Postprandial subjective fullness ratings
Description
Postprandial area under the curve of fullness ratings measured by visual analogue scales (0-100 mm)
Time Frame
5 hours
Title
Postprandial subjective satisfaction ratings
Description
Postprandial area under the curve of satisfaction ratings measured by visual analogue scales (0-100 mm)
Time Frame
5 hours
Title
Postprandial prospective food consumption ratings
Description
Postprandial area under the curve of prospective food consumption ratings measured by visual analogue scales (0-100 mm)
Time Frame
5 hours
Title
Postprandial overall appetite ratings
Description
Postprandial area under the curve of overall appetite ratings measured by visual analogue scales (0-100 mm)
Time Frame
5 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department for Health, University of Bath
City
Bath
ZIP/Postal Code
BA2 7AY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Raw data will be made available online upon publication in a peer-reviewed journal.
Citations:
PubMed Identifier
32297937
Citation
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.
Results Reference
derived

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Effect of Galactose Ingestion on Postprandial Lipemia

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