NCT03439878

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

February 14, 2018

Last Update Submit

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

EXPERIMENTAL

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

Glucose

ACTIVE COMPARATOR

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

Interventions

GalactoseDIETARY_SUPPLEMENT

Co-ingestion of d-galactose with a high-fat meal

Galactose
GlucoseDIETARY_SUPPLEMENT

Co-ingestion of d-glucose with a high-fat meal

Glucose

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

Hyperlipidemias

Interventions

GalactoseGlucose

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

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
Model Details: Randomized, blinded crossover design.
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.

Locations