ObesityECALNCT03638895
Energy Expenditure From ECAL Indirect Calorimeter in a Multicomponent Weight Management Service
A study testing ECAL Indirect Calorimeter and Diet, exercise & behaviour modification therapy in people with Obesity and Severe Obesity, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Severe Obesity, Sleep Apnoea
- What is being tested?
- ECAL Indirect Calorimeter and Diet, exercise & behaviour modification therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Nov 2018to 25 Aug 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > or equivalent to 30 kg/m2 to - 60 kg/m2
- Stable weight (change of <5% within 12 weeks before screening based on medical history)
- Subjects are well-motivated, capable and willing to learn how to undergo indirect calorimetry testing
- Willing and able to adhere to prohibitions and restrictions specified within this protocol
- For Subjects participating in the glycaemic variability sub-study:
- Subject understands instructions on the use of continuous glucose monitor sensor and is willing to undergo appropriate training and testing
Who cannot join
- Taking weight loss medication within 12 weeks prior to randomisation
- Previous or planned bariatric surgery
- History of Type 1, Type 2 diabetes mellitus, DKA or diabetes secondary to pancreatitis
- Has HbA1c > or equal to 6.5% or Fasting Plasma Glucose > or equal to 7.0 mmol/L at screening.
- NOTE: a one-time repeat measurement is allowed, if value of HbA1c and/or FPG is not consistent with prior values
- History of obesity with a known secondary cause (Cushing's disease/syndrome)
Show all 14Show fewer
- Oral corticosteroid use (except in the short term use of a 7-10 day course)
- Ongoing, inadequately controlled thyroid disorder defined as thyroid-stimulating hormone > 6 mIU/litre or < 0.4 mIU/litre
- History of malignancy within 3 years before screening (or diagnosis of malignancy within this period)
- estimated glomerular filtration rate < 30 ml/min/1.73m2 on serum testing
- Alanine aminotransferase level is <2.0 times the upper limit of normal or total bilirubin is >1.5 times the upper limit of normal at screening
- Other major illness likely to preclude participation in the trial
- History of glucagonoma
- A myocardial infarction, unstable angina, revascularisation procedure (stent or bypass graft surgery) or cerebrovascular accident within 12 weeks before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Evaluate Impact of Energy Expenditure Information on the Outcome of Weight Loss During a Standardised Multicomponent Weight Management Intervention
Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
Read the detailed description
Weight loss is important to improve overall health and reduce risk of obesity-related comorbidities such as diabetes. Numerous studies performed on individuals with predisposed genetic propensity to obesity who are deemed to be metabolically 'thrifty', require further structured intensification of caloric restriction and change in physical activity in order to achieve weight loss. Whether greater weight loss is as a result of smaller reduction in energy expenditure with calorie restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The ECAL device also measures the respiratory quotient (RQ) which is the ratio of the volume of carbon dioxide expired to that of oxygen consumed by the individual for every breath. Previous studies demonstrated variability in role of RQ in predicting weight loss, but individuals who demonstrated an RQ in the lower range (<0.72) were more likely to maintain the weight-loss achieved on a caloric restriction and avoid a weight loss rebound as compared to those with RQ in the higher range (>0.75). This suggests that RQ could prove useful in clinical practice as a prognostic marker for long-term effectiveness of low- and very-low-calorie diets used to induce weight loss. Baltimore Longitudinal Study on Aging shared a similar finding that fasting RQ or respiratory exchange ratio adjusted for age, BMI, and fat free mass was positively related to weight change. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
- Conditions
- Obesity, Severe Obesity, Sleep Apnoea
- Being tested
- ECAL Indirect Calorimeter, Diet, exercise & behaviour modification therapy
- Keywords
- weight management, obesity, severe obesity, structured dietary intervention, calorie restriction, indirect calorimetry, resting energy expenditure, resting metabolic rate, respiratory quotient, substrate oxidation, glycemic variability, insulin sensitivity, peripheral neuropathy
- Medical subject headings
- Obesity, Obesity, Morbid, Sleep Apnea Syndromes, Insulin Resistance, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECAL Indirect CalorimeterDevice
The ECAL is an open-circuit portable indirect calorimeter that measures both volume of CO2 expired and O2 consumed using a small mixing chamber. Participants will breathe through a mouthpiece with a nose clip applied whilst lying in a restful and comfortable position for 15 minutes. ECAL device will provide breath-by-breath measurements of the resting energy expenditure and respiratory quotient which will allow both practitioners and participants to monitor their metabolic health and compare the effect of dietary and physical activity intervention over the course of the structured intensive lifestyle intervention (24-weeks).
Diet, exercise & behaviour modification therapyBehavioural
Standard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.
| Study group | Role | What they receive |
|---|---|---|
| ECAL group | Active comparator | Intervention group (ECAL) - practitioners and participants receive measured energy information from ECAL indirect calorimeter including resting energy expenditure and respiratory quotient to diagnose, manage and advise on modification of caloric restriction and physical activity level. Energy information also allows participant and practitioner to monitor and compare changes to their metabolic health throughout the duration of intervention. Receives: Device: ECAL Indirect Calorimeter |
| SC group | Placebo comparator | Standard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention. Receives: Behavioral: Diet, exercise & behaviour modification therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of weight loss (in kg)
Measured: 6 months
Secondary outcomes (10)
Resting metabolic rate (RMR)
The measurement of number of calories that the body burns at rest in 24 hours, expressed as kcal/day
Measured: 6 months
Respiratory Quotient (RQ)
The ratio of carbon dioxide production to oxygen consumption and reflects the relative contribution of fat, carbohydrate, and protein in the oxidation fuel mixture.
Measured: 6 months
Secretion of gut hormones (GLP-1, GIP, PYY)
Secretion of appetite regulating gut hormone (GLP-1, GIP, PYY) in fasting and post-prandial phase
Measured: 6 months
Glycaemic variability
Change from baseline in the swings in blood glucose levels, expressed as the mean amplitude of glycaemic excursion (MAGE)
Measured: 6 months
Insulin sensitivity
Change from baseline in the measure of insulin rise in response to blood sugar levels, expressed as the homeostasis model assessment (HOMA). HOMA estimates steady state beta cell function and insulin sensitivity as percentages of the normal reference population.
Measured: 6 months
Sensory Neuropathy Testing in Prediabetic Obese Individuals
Change from baseline in vibration perception threshold measurement using the neurothesiometer
Measured: 6 months
Douleur Neuropathique en4 Questions (DN4)
Change from baseline in Douleur Neuropathique en4 Questions (DN4) using seven interview questions and three physical tests.
Measured: 6 months
Visual analogue score
Change from baseline in visual analogue score of pain, expressed as Units on a scale of 0 to 100. where 0 is worst possible health and 100 is the best possible health.
Measured: 6 months
modified Total Neuropathy Score
Change from baseline in modified Total Neuropathy Score (mTNS) questionnaire expressed as the average of the five components
Measured: 6 months
Brief Pain Inventory Short Form
Change from baseline in brief pain inventory short form (BPI-SF) scored as the mean of the seven interference items.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start28 Nov 2018
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Metabolic Health Solutions UK
- Responsible party
- Principal investigator, Prof. John Wilding, University of Liverpool
- Investigators
- John Wilding, DM FRCP, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638895
- Sponsor's protocol ID
- UoL001379
- Acronym
- ECAL
- Status last verified
- Jul 2023
- First submitted
- 13 Aug 2018
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Wang Y, Ding Z, Cao G, Hu F, Sun Y, Ma Z, Zhou D, Su B. Relative validity of an indirect calorimetry device for measuring resting energy expenditure and respiratory quotient. Asia Pac J Clin Nutr. 2018;27(1):72-77. doi: 10.6133/apjcn.032017.02.
PubMed 29222882Das SK, Saltzman E, McCrory MA, Hsu LK, Shikora SA, Dolnikowski G, Kehayias JJ, Roberts SB. Energy expenditure is very high in extremely obese women. J Nutr. 2004 Jun;134(6):1412-6. doi: 10.1093/jn/134.6.1412.
PubMed 15173405Melo CM, Tirapegui J, Ribeiro SM. [Human energetic expenditure: concepts, assessment methods and relationship to obesity]. Arq Bras Endocrinol Metabol. 2008 Apr;52(3):452-64. doi: 10.1590/s0004-27302008000300005. Portuguese.
PubMed 18506270Lam YY, Ravussin E. Indirect calorimetry: an indispensable tool to understand and predict obesity. Eur J Clin Nutr. 2017 Mar;71(3):318-322. doi: 10.1038/ejcn.2016.220. Epub 2016 Nov 16.
PubMed 27848941McLay-Cooke RT, Gray AR, Jones LM, Taylor RW, Skidmore PML, Brown RC. Prediction Equations Overestimate the Energy Requirements More for Obesity-Susceptible Individuals. Nutrients. 2017 Sep 13;9(9):1012. doi: 10.3390/nu9091012.
PubMed 28902175Alves VG, da Rocha EE, Gonzalez MC, da Fonseca RB, Silva MH, Chiesa CA. Assessement of resting energy expenditure of obese patients: comparison of indirect calorimetry with formulae. Clin Nutr. 2009 Jun;28(3):299-304. doi: 10.1016/j.clnu.2009.03.011. Epub 2009 Apr 23.
PubMed 19398250Lim J, Alam U, Cuthbertson D, Wilding J. Design of a randomised controlled trial: does indirect calorimetry energy information influence weight loss in obesity? BMJ Open. 2021 Mar 24;11(3):e044519. doi: 10.1136/bmjopen-2020-044519.
PubMed 33762240
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Evaluate Impact of Energy Expenditure Information on the Outcome of Weight Loss During a Standardised Multicomponent Weight Management Intervention
- ClinicalTrials.gov ID
- NCT03638895
- Acronym / sponsor ID
- ECAL / UoL001379
- Conditions
- Obesity, Severe Obesity, Sleep Apnoea
- Keywords
- weight management, obesity, severe obesity, structured dietary intervention, calorie restriction, indirect calorimetry, resting energy expenditure, resting metabolic rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Metabolic Health Solutions UK
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 20 Aug 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.
Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
Detailed description
Weight loss is important to improve overall health and reduce risk of obesity-related comorbidities such as diabetes. Numerous studies performed on individuals with predisposed genetic propensity to obesity who are deemed to be metabolically 'thrifty', require further structured intensification of caloric restriction and change in physical activity in order to achieve weight loss. Whether greater weight loss is as a result of smaller reduction in energy expenditure with calorie restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The ECAL device also measures the respiratory quotient (RQ) which is the ratio of the volume of carbon dioxide expired to that of oxygen consumed by the individual for every breath. Previous studies demonstrated variability in role of RQ in predicting weight loss, but individuals who demonstrated an RQ in the lower range (<0.72) were more likely to maintain the weight-loss achieved on a caloric restriction and avoid a weight loss rebound as compared to those with RQ in the higher range (>0.75). This suggests that RQ could prove useful in clinical practice as a prognostic marker for long-term effectiveness of low- and very-low-calorie diets used to induce weight loss. Baltimore Longitudinal Study on Aging shared a similar finding that fasting RQ or respiratory exchange ratio adjusted for age, BMI, and fat free mass was positively related to weight change. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| ECAL group | Active comparator | Device: ECAL Indirect CalorimeterIntervention group (ECAL) - practitioners and participants receive measured energy information from ECAL indirect calorimeter including resting energy expenditure and respiratory quotient to diagnose, manage and advise on modification of caloric restriction and physical activity level. Energy information also allows participant and practitioner to monitor and compare changes to their metabolic health throughout the duration of intervention. |
| SC group | Placebo comparator | Behavioral: Diet, exercise & behaviour modification therapyStandard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI > or equivalent to 30 kg/m2 to - 60 kg/m2
- Stable weight (change of <5% within 12 weeks before screening based on medical history)
- Subjects are well-motivated, capable and willing to learn how to undergo indirect calorimetry testing
- Willing and able to adhere to prohibitions and restrictions specified within this protocol
- Subject understands instructions on the use of continuous glucose monitor sensor and is willing to undergo appropriate training and testing
Key exclusion criteria (14 listed)
- Taking weight loss medication within 12 weeks prior to randomisation
- Previous or planned bariatric surgery
- History of Type 1, Type 2 diabetes mellitus, DKA or diabetes secondary to pancreatitis
- Has HbA1c > or equal to 6.5% or Fasting Plasma Glucose > or equal to 7.0 mmol/L at screening.
- NOTE: a one-time repeat measurement is allowed, if value of HbA1c and/or FPG is not consistent with prior values
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 |
|---|---|---|
| ECAL Indirect CalorimeterThe ECAL is an open-circuit portable indirect calorimeter that measures both volume of CO2 expired and O2 consumed using a small mixing chamber. Participants will breathe through a mouthpiece with a nose clip applied whilst lying in a restful and comfortable position for 15 minutes. ECAL device will provide breath-by-breath measurements of the resting energy expenditure and respiratory quotient which will allow both practitioners and participants to monitor their metabolic health and compare the effect of dietary and physical activity intervention over the course of the structured intensive lifestyle intervention (24-weeks). | Device | ECAL group |
| Diet, exercise & behaviour modification therapyStandard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention. | Behavioural | SC group |
Primary outcome
Magnitude of weight loss (in kg)
Time frame: 6 months
10 secondary outcomes
Resting metabolic rate (RMR)
Time frame: 6 months
Respiratory Quotient (RQ)
Time frame: 6 months
Secretion of gut hormones (GLP-1, GIP, PYY)
Time frame: 6 months
Glycaemic variability
Time frame: 6 months
Insulin sensitivity
Time frame: 6 months
Sensory Neuropathy Testing in Prediabetic Obese Individuals
Time frame: 6 months
Douleur Neuropathique en4 Questions (DN4)
Time frame: 6 months
Visual analogue score
Time frame: 6 months
modified Total Neuropathy Score
Time frame: 6 months
Brief Pain Inventory Short Form
Time frame: 6 months
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 28 Jul 2023.
- Background: PubMed 29222882Wang X, Wang Y, Ding Z, Cao G, Hu F, Sun Y, Ma Z, Zhou D, Su B. Relative validity of an indirect calorimetry device for measuring resting energy expenditure and respiratory quotient. Asia Pac J Clin Nutr. 2018;27(1):72-77. doi: 10.6133/apjcn.032017.02.
- Background: PubMed 15173405Das SK, Saltzman E, McCrory MA, Hsu LK, Shikora SA, Dolnikowski G, Kehayias JJ, Roberts SB. Energy expenditure is very high in extremely obese women. J Nutr. 2004 Jun;134(6):1412-6. doi: 10.1093/jn/134.6.1412.
- Background: PubMed 18506270Melo CM, Tirapegui J, Ribeiro SM. [Human energetic expenditure: concepts, assessment methods and relationship to obesity]. Arq Bras Endocrinol Metabol. 2008 Apr;52(3):452-64. doi: 10.1590/s0004-27302008000300005. Portuguese.
- Background: PubMed 27848941Lam YY, Ravussin E. Indirect calorimetry: an indispensable tool to understand and predict obesity. Eur J Clin Nutr. 2017 Mar;71(3):318-322. doi: 10.1038/ejcn.2016.220. Epub 2016 Nov 16.
- Background: PubMed 28902175McLay-Cooke RT, Gray AR, Jones LM, Taylor RW, Skidmore PML, Brown RC. Prediction Equations Overestimate the Energy Requirements More for Obesity-Susceptible Individuals. Nutrients. 2017 Sep 13;9(9):1012. doi: 10.3390/nu9091012.
- Background: PubMed 19398250Alves VG, da Rocha EE, Gonzalez MC, da Fonseca RB, Silva MH, Chiesa CA. Assessement of resting energy expenditure of obese patients: comparison of indirect calorimetry with formulae. Clin Nutr. 2009 Jun;28(3):299-304. doi: 10.1016/j.clnu.2009.03.011. Epub 2009 Apr 23.
- Derived from this study: PubMed 33762240Lim J, Alam U, Cuthbertson D, Wilding J. Design of a randomised controlled trial: does indirect calorimetry energy information influence weight loss in obesity? BMJ Open. 2021 Mar 24;11(3):e044519. doi: 10.1136/bmjopen-2020-044519.
- 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.
John Wilding, DM FRCP principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECAL Indirect Calorimeter and Diet, exercise & behaviour modification therapy in people with Obesity and Severe Obesity, run by University of Liverpool 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 6 inclusion and 14 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 28 Jul 2023. 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?
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?
Magnitude of weight loss (in kg) (time frame: 6 months). 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 NCT03638895, which also lists 7 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 28 Jul 2023.