Effect of Lactose on Blood Lipids

Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor; Metabolic Disease; Lipaemia
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Sucrose; Dietary supplement: Lactose

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Somerset
    • Bath, Somerset, United Kingdom, BA2 7AY
      • Department for Health, University of Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Maltodextrin; Glucose polymer; a common sugar substitute	Dietary supplement: Maltodextrin; Co-ingestion of maltodextrin with a high fat meal
Active Comparator: Sucrose; Fructose-glucose disaccharide	Dietary supplement: Sucrose; Co-ingestion of sucrose with a high fat meal
Experimental: Lactose; Galactose-glucose disaccharide	Dietary supplement: Lactose; Co-ingestion of lactose with a high fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial de Novo Lipogenesis (DNL)	Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology	6 hours
Dietary Fat Oxidation	Time course for whole-body dietary fatty acid oxidation using stable isotope methodology	6 hours
Postprandial Changes in Plasma Insulin Concentrations	Incremental area under the curve (iAUC) of plasma insulin concentrations	6 hours
Postprandial Changes in Plasma Glucose Concentrations	Incremental area under the curve (iAUC) of plasma glucose concentrations	6 hours
Postprandial Changes in Plasma Galactose Concentrations	Incremental area under the curve (iAUC) of plasma galactose concentrations	6 hours
Postprandial Changes in Plasma Fructose Concentrations	Incremental area under the curve (iAUC) of plasma fructose concentrations	6 hours
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
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
Postprandial Changes in Plasma Lactate Concentrations	Incremental area under the curve (iAUC) of plasma lactate concentrations	6 hours
Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations	Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations	6 hours
Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations	Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations	6 hours
Postprandial Changes in Plasma Uric Acid Concentrations	Incremental area under the curve (iAUC) of plasma uric acid concentrations	6 hours

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: University of Oxford; British Heart Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Metabolic Diseases
• Other Study ID Numbers: 19/NW/0630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Raw data will be made available online upon publication in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No