Effect of Lactose on Blood Lipids

University of Bath

Status: Completed

Conditions: Lipaemia; Metabolic Disease; Cardiovascular Risk Factor

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Lactose; Dietary Supplement: Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04924530

19/NW/0630

Details and patient eligibility

About

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

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 3 patient groups

Maltodextrin

Sham Comparator group

Description:

Glucose polymer; a common sugar substitute

Treatment:

Dietary Supplement: Maltodextrin

Sucrose

Active Comparator group

Description:

Fructose-glucose disaccharide

Treatment:

Dietary Supplement: Sucrose

Lactose

Experimental group

Description:

Galactose-glucose disaccharide

Treatment:

Dietary Supplement: Lactose