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Completed

NCT Number: NCT03439878

Effect of Galactose Ingestion on Postprandial Lipemia

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.

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Key information

Conditions

Cardiovascular Risk Factor Dyslipidemias Hyperlipidemias Lipemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galactose

Dietary Supplement

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

Glucose

Dietary Supplement

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

Primary outcomes

  1. Postprandial increase plasma triglyceride concentrations

    Time frame: 5 hours

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

Secondary outcomes

  1. Postprandial plasma insulin concentrations

    Time frame: 5 hours

    Incremental area under the curve (iAUC) of plasma insulin concentrations

  2. Postprandial plasma glucose concentrations

    Time frame: 5 hours

    Incremental area under the curve (iAUC) of plasma glucose concentrations

  3. Postprandial plasma non-esterified fatty acid concentrations

    Time frame: 5 hours

    Postprandial area under the curve of non-esterified fatty acid concentrations

  4. Postprandial plasma lactate concentrations

    Time frame: 5 hours

    Incremental area under the curve (iAUC) of plasma lactate concentrations

  5. Postprandial subjective hunger ratings

    Time frame: 5 hours

    Postprandial area under the curve of hunger ratings measured by visual analogue scales (0-100 mm)

  6. Postprandial subjective fullness ratings

    Time frame: 5 hours

    Postprandial area under the curve of fullness ratings measured by visual analogue scales (0-100 mm)

  7. Postprandial subjective satisfaction ratings

    Time frame: 5 hours

    Postprandial area under the curve of satisfaction ratings measured by visual analogue scales (0-100 mm)

  8. Postprandial prospective food consumption ratings

    Time frame: 5 hours

    Postprandial area under the curve of prospective food consumption ratings measured by visual analogue scales (0-100 mm)

  9. Postprandial overall appetite ratings

    Time frame: 5 hours

    Postprandial area under the curve of overall appetite ratings measured by visual analogue scales (0-100 mm)

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

The Acute Effects of Galactose Ingestion on Oral Fat Tolerance

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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