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Completed

NCT Number: NCT04924530

Effect of Lactose on Blood Lipids

This study aims to determine to what extent ingestion of free sugars influence postprandial triglyceridaemia in men and women.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

About this study

Each participant will undergo three experimental trials in a randomized, crossover research design. On each study day, participants will consume a test drink containing standardised amounts of carbohydrate and fat followed by collection of blood and breath samples to assess metabolic responses during the 6 hour postprandial period. Trials will be identical except for the type of carbohydrate contained within the test drink: 1) maltodextrin (glucose polymer), 2) lactose (galactose-glucose disaccharide) and 3) sucrose (fructose-glucose disaccharide).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18-50 years and premenopausal (for women)

Exclusion criteria

  • Weight instability (>5 kg change in body mass within last 6 months)
  • Diagnosis of any form of diabetes
  • Intolerances or allergies to any of the study procedures (e.g. lactose intolerance)
  • Galactose disorders (e.g. galactokinase deficiency, UDPgalactose-4-epimerase deficiency, galactose-1-phosphate uridyl transferase deficiency)
  • Fructose malabsorption
  • Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
  • Pregnant or lactating
  • Any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).

Treatment and study plan

Maltodextrin

Dietary Supplement

Co-ingestion of maltodextrin with a high fat meal

Sucrose

Dietary Supplement

Co-ingestion of sucrose with a high fat meal

Lactose

Dietary Supplement

Co-ingestion of lactose with a high fat meal

Primary outcomes

  1. Postprandial Changes in Plasma Triglyceride Concentrations

    Time frame: 6 hours

    Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes

Secondary outcomes

  1. Postprandial de Novo Lipogenesis (DNL)

    Time frame: 6 hours

    Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology

  2. Dietary Fat Oxidation

    Time frame: 6 hours

    Time course for whole-body dietary fatty acid oxidation using stable isotope methodology

  3. Postprandial Changes in Plasma Insulin Concentrations

    Time frame: 6 hours

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

  4. Postprandial Changes in Plasma Glucose Concentrations

    Time frame: 6 hours

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

  5. Postprandial Changes in Plasma Galactose Concentrations

    Time frame: 6 hours

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

  6. Postprandial Changes in Plasma Fructose Concentrations

    Time frame: 6 hours

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

  7. Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations

    Time frame: 6 hours

    Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride [Svedberg flotation rate (Sf): 20-400] concentrations

  8. Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations

    Time frame: 6 hours

    Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: >400) concentrations

  9. Postprandial Changes in Plasma Lactate Concentrations

    Time frame: 6 hours

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

  10. Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations

    Time frame: 6 hours

    Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations

  11. Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations

    Time frame: 6 hours

    Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations

  12. Postprandial Changes in Plasma Uric Acid Concentrations

    Time frame: 6 hours

    Incremental area under the curve (iAUC) of plasma uric acid concentrations

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Collaborators

  • British Heart Foundation
  • University of Oxford

Registry information

Official study title

Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
Sep 23, 2024

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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