Back to resultsLactose and Lipids
Primary Purpose
Cardiovascular Risk Factor, Lipaemia, Metabolic Disease
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Maltodextrin
Sucrose
Lactose
Sponsored by
About this trial
This is an interventional basic science trial for Cardiovascular Risk Factor
Eligibility Criteria
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).
Sites / Locations
- Department for Health, University of BathRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Experimental
Arm Label
Maltodextrin
Sucrose
Lactose
Arm Description
Glucose polymer; a common sugar substitute
Fructose-glucose disaccharide
Galactose-glucose disaccharide
Outcomes
Primary Outcome Measures
Postprandial changes in plasma triglyceride concentrations
Incremental area under the curve (iAUC) of plasma triglyceride concentrations
Secondary Outcome Measures
Postprandial de novo lipogenesis (DNL)
Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology
Dietary fat oxidation
Time course for whole-body dietary fatty acid oxidation using stable isotope methodology
Postprandial changes in plasma insulin concentrations
Incremental area under the curve (iAUC) of plasma insulin concentrations
Postprandial changes in plasma glucose concentrations
Incremental area under the curve (iAUC) of plasma glucose concentrations
Postprandial changes in plasma galactose concentrations
Incremental area under the curve (iAUC) of plasma galactose concentrations
Postprandial changes in plasma fructose concentrations
Incremental area under the curve (iAUC) of plasma fructose concentrations
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
Postprandial changes in plasma chylomicron-rich triglyceride (Sf: >400) concentrations
Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: >400) concentrations
Postprandial changes in plasma lactate concentrations
Incremental area under the curve (iAUC) of plasma lactate concentrations
Postprandial changes in plasma non-esterified fatty acid concentrations
Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations
Postprandial changes in plasma beta-hydroxybutyrate concentrations
Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations
Postprandial changes in plasma uric acid concentrations
Incremental area under the curve (iAUC) of plasma uric acid concentrations
Full Information
NCT ID
NCT04924530
First Posted
June 7, 2021
Last Updated
June 7, 2021
Sponsor
University of Bath
Collaborators
University of Oxford, British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04924530
Brief Title
Lactose and Lipids
Official Title
Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath
Collaborators
University of Oxford, British Heart Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Lipaemia, Metabolic Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maltodextrin
Arm Type
Sham Comparator
Arm Description
Glucose polymer; a common sugar substitute
Arm Title
Sucrose
Arm Type
Active Comparator
Arm Description
Fructose-glucose disaccharide
Arm Title
Lactose
Arm Type
Experimental
Arm Description
Galactose-glucose disaccharide
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Co-ingestion of maltodextrin with a high fat meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrose
Intervention Description
Co-ingestion of sucrose with a high fat meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose
Intervention Description
Co-ingestion of lactose with a high fat meal
Primary Outcome Measure Information:
Title
Postprandial changes in plasma triglyceride concentrations
Description
Incremental area under the curve (iAUC) of plasma triglyceride concentrations
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Postprandial de novo lipogenesis (DNL)
Description
Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology
Time Frame
6 hours
Title
Dietary fat oxidation
Description
Time course for whole-body dietary fatty acid oxidation using stable isotope methodology
Time Frame
6 hours
Title
Postprandial changes in plasma insulin concentrations
Description
Incremental area under the curve (iAUC) of plasma insulin concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma glucose concentrations
Description
Incremental area under the curve (iAUC) of plasma glucose concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma galactose concentrations
Description
Incremental area under the curve (iAUC) of plasma galactose concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma fructose concentrations
Description
Incremental area under the curve (iAUC) of plasma fructose concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma VLDL-rich triglyceride [Svedberg flotation rate (Sf): 20-400] concentrations
Description
Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride [Svedberg flotation rate (Sf): 20-400] concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma chylomicron-rich triglyceride (Sf: >400) concentrations
Description
Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: >400) concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma lactate concentrations
Description
Incremental area under the curve (iAUC) of plasma lactate concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma non-esterified fatty acid concentrations
Description
Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma beta-hydroxybutyrate concentrations
Description
Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations
Time Frame
6 hours
Title
Postprandial changes in plasma uric acid concentrations
Description
Incremental area under the curve (iAUC) of plasma uric acid concentrations
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Department for Health, University of Bath
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA2 7AY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Carter, PhD
Phone
+44 (0) 1225 384654
Email
sc2988@bath.ac.uk
First Name & Middle Initial & Last Name & Degree
Javier T Gonzalez, PhD
Phone
+44 (0) 1225 385518
Email
J.T.Gonzalez@bath.ac.uk
First Name & Middle Initial & Last Name & Degree
Dylan Thompson, PhD
First Name & Middle Initial & Last Name & Degree
James Betts, PhD
First Name & Middle Initial & Last Name & Degree
Francoise Koumanov, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Raw data will be made available online upon publication in a peer-reviewed journal.
Learn more about this trial
Lactose and Lipids
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