Lactose and Lipids

Cardiovascular Risk Factor Clinical Trial

Official title:

Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924530
• Other study ID #: 19/NW/0630
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 2022

Study information

• Verified date: June 2021
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hyperlipidemias
• Lipaemia
• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• Maltodextrin
Co-ingestion of maltodextrin with a high fat meal
• Sucrose
Co-ingestion of sucrose with a high fat meal
• Lactose
Co-ingestion of lactose with a high fat meal

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath	Somerset

Sponsors (3)

Lead Sponsor	Collaborator
University of Bath	British Heart Foundation, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial changes in plasma triglyceride concentrations	Incremental area under the curve (iAUC) of plasma triglyceride concentrations	6 hours
Secondary	Postprandial de novo lipogenesis (DNL)	Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology	6 hours
Secondary	Dietary fat oxidation	Time course for whole-body dietary fatty acid oxidation using stable isotope methodology	6 hours
Secondary	Postprandial changes in plasma insulin concentrations	Incremental area under the curve (iAUC) of plasma insulin concentrations	6 hours
Secondary	Postprandial changes in plasma glucose concentrations	Incremental area under the curve (iAUC) of plasma glucose concentrations	6 hours
Secondary	Postprandial changes in plasma galactose concentrations	Incremental area under the curve (iAUC) of plasma galactose concentrations	6 hours
Secondary	Postprandial changes in plasma fructose concentrations	Incremental area under the curve (iAUC) of plasma fructose concentrations	6 hours
Secondary	Postprandial changes in plasma VLDL-rich triglyceride [Svedberg flotation rate (Sf): 20-400] concentrations	Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride [Svedberg flotation rate (Sf): 20-400] concentrations	6 hours
Secondary	Postprandial changes in plasma chylomicron-rich triglyceride (Sf: >400) concentrations	Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: >400) concentrations	6 hours
Secondary	Postprandial changes in plasma lactate concentrations	Incremental area under the curve (iAUC) of plasma lactate concentrations	6 hours
Secondary	Postprandial changes in plasma non-esterified fatty acid concentrations	Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations	6 hours
Secondary	Postprandial changes in plasma beta-hydroxybutyrate concentrations	Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations	6 hours
Secondary	Postprandial changes in plasma uric acid concentrations	Incremental area under the curve (iAUC) of plasma uric acid concentrations	6 hours