Effect of Lactose on Blood Lipids

May 20, 2024 updated by: Javier Gonzalez, University of Bath

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postprandial Changes in Plasma Triglyceride Concentrations
Time Frame: 6 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial de Novo Lipogenesis (DNL)
Time Frame: 6 hours
Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology
6 hours
Dietary Fat Oxidation
Time Frame: 6 hours
Time course for whole-body dietary fatty acid oxidation using stable isotope methodology
6 hours
Postprandial Changes in Plasma Insulin Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma insulin concentrations
6 hours
Postprandial Changes in Plasma Glucose Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma glucose concentrations
6 hours
Postprandial Changes in Plasma Galactose Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma galactose concentrations
6 hours
Postprandial Changes in Plasma Fructose Concentrations
Time Frame: 6 hours
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
Time Frame: 6 hours
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
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: >400) concentrations
6 hours
Postprandial Changes in Plasma Lactate Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma lactate concentrations
6 hours
Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations
6 hours
Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations
6 hours
Postprandial Changes in Plasma Uric Acid Concentrations
Time Frame: 6 hours
Incremental area under the curve (iAUC) of plasma uric acid concentrations
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bath

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oxford
British Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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