Effect of Lactose on Blood Lipids

University of Bath26 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Cardiovascular Risk Factor Lipaemia Metabolic Disease

Interventions

MaltodextrinDIETARY_SUPPLEMENT

Co-ingestion of maltodextrin with a high fat meal

SucroseDIETARY_SUPPLEMENT

Co-ingestion of sucrose with a high fat meal

LactoseDIETARY_SUPPLEMENT

Co-ingestion of lactose with a high fat meal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Department for Health, University of Bath

Bath, Somerset, United Kingdom

Outcomes

Primary Outcomes

Postprandial Changes in Plasma Triglyceride Concentrations

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

Time frame: 6 hours

Secondary Outcomes

Postprandial de Novo Lipogenesis (DNL)

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

Time frame: 6 hours

Dietary Fat Oxidation

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

Time frame: 6 hours

Postprandial Changes in Plasma Insulin Concentrations

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

Time frame: 6 hours

Postprandial Changes in Plasma Glucose Concentrations

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

Time frame: 6 hours

Postprandial Changes in Plasma Galactose Concentrations

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

Time frame: 6 hours

Postprandial Changes in Plasma Fructose Concentrations

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

Time frame: 6 hours

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

Data from ClinicalTrials.gov

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