Effect of Lactose on Blood Lipids

NCT ID: NCT04924530

Last Updated: 2024-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2023-07-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Risk Factor Lipaemia Metabolic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Maltodextrin

Glucose polymer; a common sugar substitute

Group Type SHAM_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Co-ingestion of maltodextrin with a high fat meal

Sucrose

Fructose-glucose disaccharide

Group Type ACTIVE_COMPARATOR

Sucrose

Intervention Type DIETARY_SUPPLEMENT

Co-ingestion of sucrose with a high fat meal

Lactose

Galactose-glucose disaccharide

Group Type EXPERIMENTAL

Lactose

Intervention Type DIETARY_SUPPLEMENT

Co-ingestion of lactose with a high fat meal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maltodextrin

Co-ingestion of maltodextrin with a high fat meal

Intervention Type DIETARY_SUPPLEMENT

Sucrose

Co-ingestion of sucrose with a high fat meal

Intervention Type DIETARY_SUPPLEMENT

Lactose

Co-ingestion of lactose with a high fat meal

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oxford

OTHER

Sponsor Role collaborator

British Heart Foundation

OTHER

Sponsor Role collaborator

University of Bath

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Javier Gonzalez

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department for Health, University of Bath

Bath, Somerset, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19/NW/0630

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Soda and Milk Study
NCT02094768 COMPLETED NA
Effect of Sucrose on Liver Fat
NCT02015442 COMPLETED NA
Almond Consumption and Glycemia
NCT03236116 COMPLETED NA