Effect of Lactose on Blood Lipids

NCT04924530 | Completed Results

• 1 other identifier: 19/NW/0630
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Risk Factor; Lipaemia; Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Postprandial de Novo Lipogenesis (DNL)

  6 hours

• Dietary Fat Oxidation

  6 hours

• Postprandial Changes in Plasma Insulin Concentrations

  6 hours

• Postprandial Changes in Plasma Glucose Concentrations

  6 hours

• Postprandial Changes in Plasma Galactose Concentrations

  6 hours

Study Arms (3)

Maltodextrin

SHAM COMPARATOR

Glucose polymer; a common sugar substitute

Dietary Supplement: Maltodextrin

Sucrose

ACTIVE COMPARATOR

Fructose-glucose disaccharide

Dietary Supplement: Sucrose

Lactose

EXPERIMENTAL

Galactose-glucose disaccharide

Dietary Supplement: Lactose

Interventions

Maltodextrin DIETARY_SUPPLEMENT

Co-ingestion of maltodextrin with a high fat meal

Maltodextrin

Sucrose DIETARY_SUPPLEMENT

Co-ingestion of sucrose with a high fat meal

Sucrose

Lactose DIETARY_SUPPLEMENT

Co-ingestion of lactose with a high fat meal

Lactose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-50 years and premenopausal (for women)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Bath: lead
• University of Oxford: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Department for Health, University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Hyperlipidemias; Metabolic Diseases

Interventions

maltodextrin; Sucrose; Lactose

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Professor Javier Gonzalez
• Organization: University of Bath

j.t.gonzalez@bath.ac.uk

01225 38

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: June 7, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 21, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)