Clinical trial NCT04924530: Effect of Lactose on Blood Lipids
Official title: Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lipaemia
Metabolic Disease
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: British Heart Foundation
First posted: 2021-06-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Postprandial Changes in Plasma Triglyceride Concentrations
timeFrame: 6 hours
Secondary outcomes:
measure: Postprandial de Novo Lipogenesis (DNL)
timeFrame: 6 hours
measure: Dietary Fat Oxidation
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Insulin Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Glucose Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Galactose Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Fructose Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Lactate Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations
timeFrame: 6 hours
measure: Postprandial Changes in Plasma Uric Acid Concentrations
timeFrame: 6 hours
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
state: Somerset
Study officials:
References: