Lactose and Lipids

Not Applicable

• Conditions: Lipaemia; Cardiovascular Risk Factor; Metabolic Disease
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Sucrose; Dietary Supplement: Lactose

• Registration Number: NCT04924530
• Lead Sponsor: University of Bath

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).

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-07
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Study First Posted: 2021-06-14
• Last Update Posted: 2021-06-14
• Primary Completion: 2022-04
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	Glucose polymer; a common sugar substitute
Sucrose	Sucrose	Fructose-glucose disaccharide
Lactose	Lactose	Galactose-glucose disaccharide

Primary Outcome Measures

Name	Time	Method
Postprandial Changes in Plasma Triglyceride Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes

Secondary Outcome Measures

Name	Time	Method
Postprandial de Novo Lipogenesis (DNL)	6 hours	Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology
Dietary Fat Oxidation	6 hours	Time course for whole-body dietary fatty acid oxidation using stable isotope methodology
Postprandial Changes in Plasma Insulin Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma insulin concentrations
Postprandial Changes in Plasma Glucose Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma glucose concentrations
Postprandial Changes in Plasma Galactose Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma galactose concentrations
Postprandial Changes in Plasma Fructose Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma fructose concentrations
Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride \[Svedberg flotation rate (Sf): 20-400\] concentrations
Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: \>400) concentrations
Postprandial Changes in Plasma Lactate Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma lactate concentrations
Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations
Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations
Postprandial Changes in Plasma Uric Acid Concentrations	6 hours	Incremental area under the curve (iAUC) of plasma uric acid concentrations

Trial Locations

Locations (1)

Department for Health, University of Bath; 🇬🇧 Bath, Somerset, United Kingdom