Cardiovascular Risk FactorNCT04924530
Effect of Lactose on Blood Lipids
A study testing Maltodextrin, Sucrose and Lactose in people with Cardiovascular Risk Factor and Lipaemia, run by University of Bath at 1 site in United Kingdom.
Trial summary
This study aims to determine to what extent ingestion of free sugars influence postprandial triglyceridaemia in men and women. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Lipaemia, Metabolic Disease
- What is being tested?
- Maltodextrin, Sucrose and Lactose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2021to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-50 years and premenopausal (for women)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, Somerset, BA2 7AY
About this study
Official title: 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.
Read the 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).
- Conditions
- Cardiovascular Risk Factor, Lipaemia, Metabolic Disease
- Being tested
- Maltodextrin, Sucrose, Lactose
- Medical subject headings
- Hyperlipidemias, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaltodextrinDietary supplement
Co-ingestion of maltodextrin with a high fat meal
SucroseDietary supplement
Co-ingestion of sucrose with a high fat meal
LactoseDietary supplement
Co-ingestion of lactose with a high fat meal
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Sham comparator | Glucose polymer; a common sugar substitute Receives: Dietary Supplement: Maltodextrin |
| Sucrose | Active comparator | Fructose-glucose disaccharide Receives: Dietary Supplement: Sucrose |
| Lactose | Experimental | Galactose-glucose disaccharide Receives: Dietary Supplement: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours
Secondary outcomes (12)
Postprandial de Novo Lipogenesis (DNL)
Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology
Measured: 6 hours
Dietary Fat Oxidation
Time course for whole-body dietary fatty acid oxidation using stable isotope methodology
Measured: 6 hours
Postprandial Changes in Plasma Insulin Concentrations
Incremental area under the curve (iAUC) of plasma insulin concentrations
Measured: 6 hours
Postprandial Changes in Plasma Glucose Concentrations
Incremental area under the curve (iAUC) of plasma glucose concentrations
Measured: 6 hours
Postprandial Changes in Plasma Galactose Concentrations
Incremental area under the curve (iAUC) of plasma galactose concentrations
Measured: 6 hours
Postprandial Changes in Plasma Fructose Concentrations
Incremental area under the curve (iAUC) of plasma fructose concentrations
Measured: 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
Measured: 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
Measured: 6 hours
Postprandial Changes in Plasma Lactate Concentrations
Incremental area under the curve (iAUC) of plasma lactate concentrations
Measured: 6 hours
Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations
Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations
Measured: 6 hours
Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations
Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations
Measured: 6 hours
Postprandial Changes in Plasma Uric Acid Concentrations
Incremental area under the curve (iAUC) of plasma uric acid concentrations
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start7 Jun 2021
- Primary completion13 Jul 2022
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, British Heart Foundation
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924530
- Sponsor's protocol ID
- 19/NW/0630
- Status last verified
- May 2024
- First submitted
- 7 Jun 2021
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Raw data will be made available online upon publication in a peer-reviewed journal.
Publications
Carter S, Spellanzon B, Johnson E, Koumanov F, Dennis KMJH, Taylor Start CA, Bradshaw L, Moreno-Cabanas A, Merrell LH, Vincent EE, Deslandes B, Maher JL, Neville MJ, Betts JA, Thompson D, Hodson L, Gonzalez JT. Lactose and Sucrose Each Stimulate Hepatic De Novo Lipogenesis: A Randomised Crossover Trial. Am J Clin Nutr. 2026 Aug 25:101492. doi: 10.1016/j.ajcnut.2026.101492. Online ahead of print.
PubMed 42641959
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing the Mechanisms by Which Milk Sugars Exaggerate Postprandial Lipaemia
- ClinicalTrials.gov ID
- NCT04924530
- Acronym / sponsor ID
- 19/NW/0630
- Conditions
- Cardiovascular Risk Factor, Lipaemia, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Oxford, British Heart Foundation
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Sham comparator | Dietary Supplement: MaltodextrinGlucose polymer; a common sugar substitute |
| Sucrose | Active comparator | Dietary Supplement: SucroseFructose-glucose disaccharide |
| Lactose | Experimental | Dietary Supplement: LactoseGalactose-glucose disaccharide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age: 18-50 years and premenopausal (for women)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaltodextrinCo-ingestion of maltodextrin with a high fat meal | Dietary supplement | Maltodextrin |
| SucroseCo-ingestion of sucrose with a high fat meal | Dietary supplement | Sucrose |
| LactoseCo-ingestion of lactose with a high fat meal | Dietary supplement | Lactose |
Primary outcome
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
12 secondary outcomes
Postprandial de Novo Lipogenesis (DNL)
Time frame: 6 hours
Dietary Fat Oxidation
Time frame: 6 hours
Postprandial Changes in Plasma Insulin Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Glucose Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Galactose Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Fructose Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma VLDL-rich Triglyceride [Svedberg Flotation Rate (Sf): 20-400] Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Chylomicron-rich Triglyceride (Sf: >400) Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Lactate Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Non-esterified Fatty Acid Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Beta-hydroxybutyrate Concentrations
Time frame: 6 hours
Postprandial Changes in Plasma Uric Acid Concentrations
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42641959Carter S, Spellanzon B, Johnson E, Koumanov F, Dennis KMJH, Taylor Start CA, Bradshaw L, Moreno-Cabanas A, Merrell LH, Vincent EE, Deslandes B, Maher JL, Neville MJ, Betts JA, Thompson D, Hodson L, Gonzalez JT. Lactose and Sucrose Each Stimulate Hepatic De Novo Lipogenesis: A Randomised Crossover Trial. Am J Clin Nutr. 2026 Aug 25:101492. doi: 10.1016/j.ajcnut.2026.101492. Online ahead of print.
- Individual participant dataSharing planned: No. Raw data will be made available online upon publication in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin, Sucrose and Lactose in people with Cardiovascular Risk Factor and Lipaemia, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Changes in Plasma Triglyceride Concentrations (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.