Cigarette SmokingNCT03735186
Exercise and Coronary Heart Disease Risk Markers in Male Smokers and Non-Smokers
A study testing Exercise in people with Cigarette Smoking and Coronary Heart Disease, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The present study will investigate the effect of acute exercise on fasting and postprandial risk markers for coronary heart disease (CHD) in healthy male cigarette smokers and non-smokers. Participants will complete two, 2-day trials in a random crossover design separated by an interval of at least 1 week. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Coronary Heart Disease, Cardiovascular Risk Factor
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2017to 2 Oct 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20- to 45-year-old healthy male smokers or non-smokers;
- Be able to exercise continuously for 1 hour;
- Body mass index between 18.5 and 29.9 kg/m2;
- Weight stable for the past 3 months;
- No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
- A regular cigarette smoker or non-smoker for the last 12 months according to the definition below;
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- The National Health Interview Survey (NHIS) definitions will be used to identify cigarette smokers and non-smokers (Link: NHIS Adult Tobacco Use):
- Current smokers will be defined as an adult who has smoked ≥100 cigarettes in their lifetime and who currently smokes cigarettes every day.
- Non-smokers will be defined as an adult who has never smoked or who has smoked < 100 cigarettes in their lifetime
- The following questions will determine the eligibility and group allocation:
- Do you currently smoke cigarettes on a daily basis?
- Have you smoked at least 100 cigarettes in your entire life?
- If the person answers YES to Q1 and YES to Q2 they are eligible for the study and will be allocated to the smokers group.
- If the person answers NO to Q1 and NO to Q2 they are eligible for the study and will be allocated to the non-smokers group.
- Individuals answering any other combination (YES, NO or NO, YES) will not be eligible to take part in the study.
Who cannot join
- Not meeting the criteria for a smoker or non-smoker (defined above);
- Current E-Cigarette smoker;
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Any muscle or bone injuries that do not allow them to walk and run on a treadmill;
- Uncontrolled exercise-induced asthma;
- Heart conditions;
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- Coagulation or bleeding disorders;
- Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
- Taking any medication that might influence fat metabolism;
- Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
- Dieting or restrained eating behaviours;
- Weight fluctuation greater than 3 kg in the 3 months prior to study enrolment;
- A food allergy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Acute Exercise and Coronary Heart Disease Risk Markers in Healthy Male Smokers and Non-Smokers
The present study will investigate the effect of acute exercise on fasting and postprandial risk markers for coronary heart disease (CHD) in healthy male cigarette smokers and non-smokers.
Participants will complete two, 2-day trials in a random crossover design separated by an interval of at least 1 week. On day 1, participants will rest (control) or complete 60 minute of treadmill exercise at 60% of maximum oxygen uptake (exercise). On day 2, participants will rest and consume two high fat meals (breakfast and lunch) over an 8-h period during which 13 venous blood samples and nine blood pressure measurements will be taken at pre-determined intervals.
It is hypothesised that men who smoke cigarettes will exhibit impaired fasting and postprandial metabolic risk markers compared to non-smokers, but a single bout of exercise will be equally, if not more, efficacious for improving the CHD risk factor profile in smokers than non-smokers.
Read the detailed description
Cigarette smoking is a strong and independent risk factor for CHD and is associated with impaired postprandial metabolism. Previous studies suggest that postprandial metabolism and other risk markers for CHD can be improved with acute exercise in healthy non-smokers, but less is known about responses in cigarette smokers. Therefore, the present study will compare the effect of acute exercise on fasting and postprandial risk markers for CHD in healthy male cigarette smokers and non-smokers.
A total of 12 healthy male cigarette smokers and 12 healthy male non-smokers matched for age and body mass index will be recruited. Before the main experimental trials, participants will attend the laboratory for a preliminary visit to complete screening questionnaires and to undergo familiarisation, anthropometric measurements (stature, body mass, waist and hip circumference, body fat) and exercise testing to determine maximum oxygen uptake.
Participants will complete two, 2-day (08:00-17:00) experimental trials in a randomised cross over design: control and exercise. On day 1, participants will arrive at the laboratory at 08:00 having fasted overnight and a baseline fasting venous blood sample and blood pressure measurement will be taken. A high fat breakfast and lunch meal will be consumed at 08:30 and 12:00, respectively. The control and exercise trials will be identical, except a 60 min bout of treadmill exercise at 60% of maximum oxygen uptake will be performed at 14:30 in the exercise trial.
On day 2, participants will arrive at 08:00 having fasted overnight for 10 h and will rest in the laboratory until 17:00. Participants in the smokers group will be asked to stop smoking at 08:00. A high fat breakfast and lunch will be consumed at 09:00 and 13:00, respectively. Venous blood samples from a cannula will be collected in the fasted state and at 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7 and 8 h after the breakfast meal. Resting arterial blood pressure will be measured in the fasted state and at hourly intervals thereafter.
- Conditions
- Cigarette Smoking, Coronary Heart Disease, Cardiovascular Risk Factor, Insulin Resistance, Oxidative Stress, Inflammation
- Being tested
- Exercise
- Keywords
- Coronary heart disease, Exercise, Inflammation, Postprandial lipaemia, Smoking
- Medical subject headings
- Cigarette Smoking, Coronary Disease, Insulin Resistance, Inflammation, Motor Activity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
60 min treadmill exercise performed at 60% of maximum oxygen uptake.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Exercise | Experimental | Participants will complete 60 min of treadmill exercise on day 1 (14:30-15:30). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triacylglycerol concentration
Total area under the plasma triacylglycerol concentration versus time curve on day 2
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 hours)
Secondary outcomes (14)
Glucose concentration
Time-course of plasma glucose concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 hours)
Insulin concentration
Time-course of plasma insulin concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Homeostasis model assessment of insulin resistance (HOMA-IR)
Homeostasis model assessment of insulin resistance (HOMA-IR) on day 2 of the exercise and control trials using fasting glucose and insulin concentrations.
Measured: Fasting (Plasma samples will be collected at 0 (fasted) hours)
Non-esterified fatty acids concentration
Time-course of plasma non-esterified fatty acid concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Total cholesterol concentration
Circulating concentrations of plasma total cholesterol in the fasted state on day 2 of the exercise and control trials.
Measured: Fasting (Plasma samples will be collected at 0 (fasted) hours)
High-density lipoprotein cholesterol concentration
Circulating concentrations of plasma high-density lipoprotein cholesterol in the fasted state on day 2 of the exercise and control trials.
Measured: Fasting (Plasma samples will be collected at 0 (fasted) hours)
Low-density lipoprotein cholesterol concentration
Circulating concentrations of plasma low-density lipoprotein cholesterol in the fasted state on day 2 of the exercise and control trials.
Measured: Fasting (Plasma samples will be collected at 0 (fasted) hours)
C-reactive protein concentration
Time-course of plasma C-reactive protein concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Interleukin-6 concentration
Time-course of plasma interleukin-6 concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Interleukin-10 concentration
Time-course of plasma interleukin-10 concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Tumor necrosis factor alpha concentration
Time-course of plasma tumor necrosis factor alpha concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Peroxiredoxin-4 concentration
Time-course of plasma peroxiredoxin-4 concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Superoxide dismutase 3 concentration
Time-course of plasma superoxide dismutase 3 concentrations on day 2 of the exercise and control trials.
Measured: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Systolic and diastolic blood pressure
Time-course of systolic and diastolic blood pressure on day 2 of the exercise and control trials.
Measured: 8 hours (Blood pressure will be measured at 0 (fasted), 1, 2, 3, 4, 5, 6, 7, 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start4 Aug 2017
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, University Hospitals, Leicester
- Responsible party
- Principal investigator, Tareq Alotaibi, Loughborough University
- Investigators
- David Stensel, Principal investigator, Loughborough UniversityTareq Alotaibi, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735186
- Sponsor's protocol ID
- R17-P055
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
PubMed 26438068Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
PubMed 23470315Miyashita M, Burns SF, Stensel DJ. Accumulating short bouts of brisk walking reduces postprandial plasma triacylglycerol concentrations and resting blood pressure in healthy young men. Am J Clin Nutr. 2008 Nov;88(5):1225-31. doi: 10.3945/ajcn.2008.26493.
PubMed 18996856Alotaibi TF, Thackray AE, Roberts MJ, Alanazi TM, Bishop NC, Wadley AJ, King JA, O'Donnell E, Steiner MC, Singh SJ, Stensel DJ. Acute Running and Coronary Heart Disease Risk Markers in Male Cigarette Smokers and Nonsmokers: A Randomized Crossover Trial. Med Sci Sports Exerc. 2021 May 1;53(5):1021-1032. doi: 10.1249/MSS.0000000000002560.
PubMed 33196606
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exercise and Coronary Heart Disease Risk Markers in Healthy Male Smokers and Non-Smokers
- ClinicalTrials.gov ID
- NCT03735186
- Acronym / sponsor ID
- R17-P055
- Conditions
- Cigarette Smoking, Coronary Heart Disease, Cardiovascular Risk Factor, Insulin Resistance, Oxidative Stress, Inflammation
- Keywords
- Coronary heart disease, Exercise, Inflammation, Postprandial lipaemia, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University of Leicester, University Hospitals, Leicester
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 8 Nov 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.
The present study will investigate the effect of acute exercise on fasting and postprandial risk markers for coronary heart disease (CHD) in healthy male cigarette smokers and non-smokers.
Participants will complete two, 2-day trials in a random crossover design separated by an interval of at least 1 week. On day 1, participants will rest (control) or complete 60 minute of treadmill exercise at 60% of maximum oxygen uptake (exercise). On day 2, participants will rest and consume two high fat meals (breakfast and lunch) over an 8-h period during which 13 venous blood samples and nine blood pressure measurements will be taken at pre-determined intervals.
It is hypothesised that men who smoke cigarettes will exhibit impaired fasting and postprandial metabolic risk markers compared to non-smokers, but a single bout of exercise will be equally, if not more, efficacious for improving the CHD risk factor profile in smokers than non-smokers.
Detailed description
Cigarette smoking is a strong and independent risk factor for CHD and is associated with impaired postprandial metabolism. Previous studies suggest that postprandial metabolism and other risk markers for CHD can be improved with acute exercise in healthy non-smokers, but less is known about responses in cigarette smokers. Therefore, the present study will compare the effect of acute exercise on fasting and postprandial risk markers for CHD in healthy male cigarette smokers and non-smokers.
A total of 12 healthy male cigarette smokers and 12 healthy male non-smokers matched for age and body mass index will be recruited. Before the main experimental trials, participants will attend the laboratory for a preliminary visit to complete screening questionnaires and to undergo familiarisation, anthropometric measurements (stature, body mass, waist and hip circumference, body fat) and exercise testing to determine maximum oxygen uptake.
Participants will complete two, 2-day (08:00-17:00) experimental trials in a randomised cross over design: control and exercise. On day 1, participants will arrive at the laboratory at 08:00 having fasted overnight and a baseline fasting venous blood sample and blood pressure measurement will be taken. A high fat breakfast and lunch meal will be consumed at 08:30 and 12:00, respectively. The control and exercise trials will be identical, except a 60 min bout of treadmill exercise at 60% of maximum oxygen uptake will be performed at 14:30 in the exercise trial.
On day 2, participants will arrive at 08:00 having fasted overnight for 10 h and will rest in the laboratory until 17:00. Participants in the smokers group will be asked to stop smoking at 08:00. A high fat breakfast and lunch will be consumed at 09:00 and 13:00, respectively. Venous blood samples from a cannula will be collected in the fasted state and at 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7 and 8 h after the breakfast meal. Resting arterial blood pressure will be measured in the fasted state and at hourly intervals thereafter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Exercise | Experimental | Behavioral: ExerciseParticipants will complete 60 min of treadmill exercise on day 1 (14:30-15:30). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 20- to 45-year-old healthy male smokers or non-smokers;
- Be able to exercise continuously for 1 hour;
- Body mass index between 18.5 and 29.9 kg/m2;
- Weight stable for the past 3 months;
- No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
Key exclusion criteria (13 listed)
- Not meeting the criteria for a smoker or non-smoker (defined above);
- Current E-Cigarette smoker;
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Any muscle or bone injuries that do not allow them to walk and run on a treadmill;
- Uncontrolled exercise-induced asthma;
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 |
|---|---|---|
| Exercise60 min treadmill exercise performed at 60% of maximum oxygen uptake. | Behavioural | Exercise |
Primary outcome
Triacylglycerol concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 hours)
Total area under the plasma triacylglycerol concentration versus time curve on day 2
14 secondary outcomes
Glucose concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 hours)
Insulin concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
Non-esterified fatty acids concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Total cholesterol concentration
Time frame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
High-density lipoprotein cholesterol concentration
Time frame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
Low-density lipoprotein cholesterol concentration
Time frame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
C-reactive protein concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Interleukin-6 concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Interleukin-10 concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Tumor necrosis factor alpha concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Peroxiredoxin-4 concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Superoxide dismutase 3 concentration
Time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Systolic and diastolic blood pressure
Time frame: 8 hours (Blood pressure will be measured at 0 (fasted), 1, 2, 3, 4, 5, 6, 7, 8 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 9 Nov 2018.
- Background: PubMed 26438068Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
- Background: PubMed 23470315Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
- Background: PubMed 18996856Miyashita M, Burns SF, Stensel DJ. Accumulating short bouts of brisk walking reduces postprandial plasma triacylglycerol concentrations and resting blood pressure in healthy young men. Am J Clin Nutr. 2008 Nov;88(5):1225-31. doi: 10.3945/ajcn.2008.26493.
- Derived from this study: PubMed 33196606Alotaibi TF, Thackray AE, Roberts MJ, Alanazi TM, Bishop NC, Wadley AJ, King JA, O'Donnell E, Steiner MC, Singh SJ, Stensel DJ. Acute Running and Coronary Heart Disease Risk Markers in Male Cigarette Smokers and Nonsmokers: A Randomized Crossover Trial. Med Sci Sports Exerc. 2021 May 1;53(5):1021-1032. doi: 10.1249/MSS.0000000000002560.
- Individual participant dataSharing planned: No
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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.
David Stensel principal investigator
Loughborough University
Tareq Alotaibi principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cigarette Smoking and Coronary Heart Disease, run by Loughborough University 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 15 inclusion and 13 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 9 Nov 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?
Triacylglycerol concentration (time frame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 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 NCT03735186, which also lists 4 linked publications.
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 9 Nov 2018.