Effect of Galactose Ingestion on Postprandial Lipemia
The Acute Effects of Galactose Ingestion on Oral Fat Tolerance
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 24, 2018
May 1, 2018
3 months
February 14, 2018
May 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial increase plasma triglyceride concentrations
Incremental area under the curve (iAUC) of plasma triglyceride concentrations
5 hours
Secondary Outcomes (9)
Postprandial plasma insulin concentrations
5 hours
Postprandial plasma glucose concentrations
5 hours
Postprandial plasma non-esterified fatty acid concentrations
5 hours
Postprandial plasma lactate concentrations
5 hours
Postprandial subjective hunger ratings
5 hours
- +4 more secondary outcomes
Study Arms (2)
Galactose
EXPERIMENTALIngestion of 0.75 g/kg body mass of d-galactose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat.
Glucose
ACTIVE COMPARATORIngestion of 0.75 g/kg body mass of dextrose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat.
Interventions
Eligibility Criteria
You may qualify if:
- Male
- to 35 years old
- Body mass index \<30 kg/m2
You may not qualify if:
- Female
- Body mass index \>29.9 kg/m2
- Any history of metabolic disease
- Allergies or intolerances to milk and/or cream
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department for Health, University of Bath
Bath, BA2 7AY, United Kingdom
Related Publications (1)
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.
PMID: 32297937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and the researchers performing biochemical analyses will be blinded to the intervention.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 20, 2018
Study Start
February 1, 2018
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 24, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share
Raw data will be made available online upon publication in a peer-reviewed journal.