Cardiovascular Risk FactorNCT03439878
Effect of Galactose Ingestion on Postprandial Lipemia
A study testing Galactose and Glucose in people with Cardiovascular Risk Factor and Lipemia, run by University of Bath at 1 site in United Kingdom.
Trial summary
This study aims to assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Lipemia
- What is being tested?
- Galactose and Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18 to 35 years old
- Body mass index <30 kg/m2
Who cannot join
- Female
- Body mass index >29.9 kg/m2
- Any history of metabolic disease
- Allergies or intolerances to milk and/or cream
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: The Acute Effects of Galactose Ingestion on Oral Fat Tolerance
This study aims to assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose.
- Conditions
- Cardiovascular Risk Factor, Lipemia
- Being tested
- Galactose, Glucose
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalactoseDietary supplement
Co-ingestion of d-galactose with a high-fat meal
GlucoseDietary supplement
Co-ingestion of d-glucose with a high-fat meal
| Study group | Role | What they receive |
|---|---|---|
| Galactose | Experimental | Ingestion of 0.75 g/kg body mass of d-galactose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat. Receives: Dietary Supplement: Galactose |
| Glucose | Active comparator | Ingestion of 0.75 g/kg body mass of dextrose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat. Receives: Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial increase plasma triglyceride concentrations
Incremental area under the curve (iAUC) of plasma triglyceride concentrations
Measured: 5 hours
Secondary outcomes (9)
Postprandial plasma insulin concentrations
Incremental area under the curve (iAUC) of plasma insulin concentrations
Measured: 5 hours
Postprandial plasma glucose concentrations
Incremental area under the curve (iAUC) of plasma glucose concentrations
Measured: 5 hours
Postprandial plasma non-esterified fatty acid concentrations
Postprandial area under the curve of non-esterified fatty acid concentrations
Measured: 5 hours
Postprandial plasma lactate concentrations
Incremental area under the curve (iAUC) of plasma lactate concentrations
Measured: 5 hours
Postprandial subjective hunger ratings
Postprandial area under the curve of hunger ratings measured by visual analogue scales (0-100 mm)
Measured: 5 hours
Postprandial subjective fullness ratings
Postprandial area under the curve of fullness ratings measured by visual analogue scales (0-100 mm)
Measured: 5 hours
Postprandial subjective satisfaction ratings
Postprandial area under the curve of satisfaction ratings measured by visual analogue scales (0-100 mm)
Measured: 5 hours
Postprandial prospective food consumption ratings
Postprandial area under the curve of prospective food consumption ratings measured by visual analogue scales (0-100 mm)
Measured: 5 hours
Postprandial overall appetite ratings
Postprandial area under the curve of overall appetite ratings measured by visual analogue scales (0-100 mm)
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Feb 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized, blinded crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439878
- Sponsor's protocol ID
- MSES 16/17-011
- Status last verified
- May 2018
- First submitted
- 14 Feb 2018
- Last updated
- 24 May 2018
- Results posted
- No
- 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
Watkins J, Simpson A, Betts JA, Thompson D, Holliday A, Deighton K, Gonzalez JT. Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men. J Nutr. 2020 Jul 1;150(7):1765-1772. doi: 10.1093/jn/nxaa105.
PubMed 32297937
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Galactose Ingestion on Oral Fat Tolerance
- ClinicalTrials.gov ID
- NCT03439878
- Acronym / sponsor ID
- MSES 16/17-011
- Conditions
- Cardiovascular Risk Factor, Lipemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
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 assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, blinded crossover design.
| Arm | Type | Receives |
|---|---|---|
| Galactose | Experimental | Dietary Supplement: GalactoseIngestion of 0.75 g/kg body mass of d-galactose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat. |
| Glucose | Active comparator | Dietary Supplement: GlucoseIngestion of 0.75 g/kg body mass of dextrose monohydrate co-ingested with cream to provide 1 g/kg body mass of fat. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18 to 35 years old
- Body mass index <30 kg/m2
Key exclusion criteria (4 listed)
- Female
- Body mass index >29.9 kg/m2
- Any history of metabolic disease
- Allergies or intolerances to milk and/or cream
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 |
|---|---|---|
| GalactoseCo-ingestion of d-galactose with a high-fat meal | Dietary supplement | Galactose |
| GlucoseCo-ingestion of d-glucose with a high-fat meal | Dietary supplement | Glucose |
Primary outcome
Postprandial increase plasma triglyceride concentrations
Time frame: 5 hours
Incremental area under the curve (iAUC) of plasma triglyceride concentrations
9 secondary outcomes
Postprandial plasma insulin concentrations
Time frame: 5 hours
Postprandial plasma glucose concentrations
Time frame: 5 hours
Postprandial plasma non-esterified fatty acid concentrations
Time frame: 5 hours
Postprandial plasma lactate concentrations
Time frame: 5 hours
Postprandial subjective hunger ratings
Time frame: 5 hours
Postprandial subjective fullness ratings
Time frame: 5 hours
Postprandial subjective satisfaction ratings
Time frame: 5 hours
Postprandial prospective food consumption ratings
Time frame: 5 hours
Postprandial overall appetite ratings
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Derived from this study: PubMed 32297937Watkins J, Simpson A, Betts JA, Thompson D, Holliday A, Deighton K, Gonzalez JT. Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men. J Nutr. 2020 Jul 1;150(7):1765-1772. doi: 10.1093/jn/nxaa105.
- 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 Galactose and Glucose in people with Cardiovascular Risk Factor and Lipemia, 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 3 inclusion and 4 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 24 May 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 increase plasma triglyceride concentrations (time frame: 5 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 NCT03439878, 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 24 May 2018.