MalnutritionPhase 1CanPanNCT05503147
Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)
A Phase 1 study testing Sativex in people with Malnutrition and Anorexia, run by Ove Andersen at 1 site in Denmark.
Trial summary
Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition, Anorexia, Cannabis
- What is being tested?
- Sativex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Mar 2022to 1 Sep 2023
- Phase
- Phase 1
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years of age
- Admitted to the acute medical department, Hvidovre Hospital
- Can cooperate cognitively and physically (patient reported)
- Low appetite/anorexia of ageing measures by SNAQ score ≤14
- BMI ≤30 (screening)
- Able to read and understand Danish
- Postmenopausal defined as missed periods for at least 12 months before the start of the trial
Who cannot join
- Regular use of medical cannabis (patient reported)
- Use of medical cannabis within 14 days at baseline (patient reported)
- Recognized or suspected psychotic illness in the subject or the subjects family (medical record and patient report)
- Severe personality disorders (journal)
- Significant psychiatric disorder in addition to mild to moderate depression (medical record)
- Allergy to the ingredients of Sativex®, placebo and Hexamycin® (patient reported)
Show all 26Show fewer
- Terminal diagnosis (journal)
- Liver transplant (journal)
- Chronic eGFR ≤15 mL / min2 or dialysis treatment (medical record)
- High risk of nephrotoxicity due to existing drug treatment (medical assessment)
- Pacemaker (journal)
- Epilepsy (journal)
- Recurrent seizures (journal)
- Uncontrolled hypertension (journal)
- Food intolerance to the ingredients in the test meals (patient-reported)
- Vegetarian and vegan (patient-reported)
- Unwilling to avoid driving for up to 72 hours after administration of Sativex® (patient-reported)
- Unwilling to avoid alcohol 24 hours up to test days (patient-reported)
- Patients with ascites ( journal)
- Patients with significant edema on the days of the trial (journal / visual inspection)
- In active treatment of cancer or have disseminated cancer (journal)
- Known with brain - or kidney tumor (journal)
- Known with angina pectoris or intermittent claudication
- Known with stroke, AMI, or heart failure (NYHA III-IV) within the past 5 years (journal)
- In isolation
- Obs. Covid-19
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Clinical Research Centre
Hvidovre, 2650
Ove Andersen, MSc, PhD, 004538623335, ove.andersen@regionh.dk
Linda Andresen, MBA, 004538623322, linda.camilla.andresen@regionh.dk
About this study
Official title: A Pharmacological Trial With Sativex® and Gentamicin for Optimized Phamacological Treatment of Older Patients With Focus on Appetite Stimulation and Renal Risk Drugs
Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs.
The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.
Read the detailed description
The CanPan trial consists of sub study 1 and sub study 2. Subjects who meet all the inclusion criteria and none of the exclusion criteria are invited to participate in both sub studies. Sub study 1 consist of trial days 1 and 2 and sub study 2 consists of trial day 3.
Sub study 1:
Sub study 1 is a double-blinded, randomized, placebo-controlled, multidose, crossover trial that evaluates the appetite stimulating effect as well as the pharmacokinetics of Sativex®. The primary purpose of sub study 1 is to 1) uncover whether Sativex® has appetite stimulating properties defined as increased energy intake compared to placebo, 2) to develop a pharmacokinetic-pharmacodynamic model, and gain knowledge about the effect of Sativex® on other markers of appetite, the intraocular pressure of the eye and safety parameters.
In sub study 1, subjects receive both Sativex® and placebo. Both Sativex® and placebo are administered as an oromucosal spray. Sativex consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dose of spray (Cannabis sativa L. extract, cannabis leaf and flower). Subjects receive three dose of spray two times during a trial day. Trial day 1 is planned <14 days after inclusion and there is a 2-week break between trial days 1 and 2 due to a wash-out period. Follow-up visits/phonecalls are made on days 1, 2 and 7 after trial days 1 and 2.
Sub study 2:
Sub-study 2 is a single-dose pharmacokinetic study using gentamicin (Hexamycin®) as a renally excreted model drug. The purpose of sub study 2 is to compare the prediction accuracy of clearance estimates between eGFRpanel (creatinine-cystatinC-beta-2_microglobulin-beta_trace_protein, eGFRcomb (creatinine-cystatinC), eGFRcreatinine (creatinine), uCrCl (24-hour urine creatinine clearance) and mGFR (measured GFR) as covariates in population based pharmacokinetic modeling of gentamicin.
On trial day 3, gentamicin is used as the model substance for a drug that is excreted > 90% renally. Gentamicin is administered as a single dose of 5 mg/kg as an intravenous injection (bolus). The marketed drug, Hexamycin® (40 mg / mL), is used for this purpose. Trial day 3 is held within 4 weeks after trial day 2. Follow-up visits are made on day 1 and 2 after trial day 3.
- Conditions
- Malnutrition, Anorexia, Cannabis, Aging, Emergency Service, Hospital, Renal Function
- Being tested
- Sativex
- Medical subject headings
- Malnutrition, Anorexia, Marijuana Abuse, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called nabiximols
Sativex® is administered as an oromucosal spray and consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dosis spray (Cannabis sativa L. extract, cannabis leaf and flower). The dose (3 sprays) is administered twice, at breakfast and lunch, respectively, with approximately 4 hours between each administration.
| Study group | Role | What they receive |
|---|---|---|
| Sativex first (blinded) (3 dose of spray) | Experimental | Trial day 1: Sativex (3 dose of spray x 2) Trial day 2: Placebo (3 dose of spray x 2) Trial day 3: Voluntary Receives: Drug: Sativex |
| Placebo first (blinded) (3 dose of spray) | Experimental | Trial day 1: Placebo (3 dose of spray x 2) Trial day 2: Sativex (3 dose of spray x 2) Trial day 3: Voluntary Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in energy intake (kJ) between Sativex® and placebo
Measured at test meal
Measured: Trial days 1 and 2.
Differences in the objective function value of the population-based pharmacokinetic model when implementing renal clearance assessed by measured GFR (mL/min), or GFR estimates based on different endogenous markers, as covariates on gentamicin clearance
The objective function value (minus two times the log-likelihood) describes the prediction accuracy (goodness-of-fit) of a population pharmacokinetic model. A drop in the objective function value of 6.63 in a model with one (1) added covariate implemented on any specific parameter compared to a base model corresponds to a significant improvement in model fit with a p-value of 0.01 in a chi-squared test.
Population-based pharmacokinetic modelling is an analysis method performed on pharmacokinetic data, i.e., plasma concentrations over time. Relevant pharmacokinetic parameters are estimated simultaneously by fitting the data to the model. The model structure is found through the analysis and determines which pharmacokinetic parameters are estimated. As a minimum, the clearance and distribution volume of the central compartment are estimated
Measured: Trial day 3.
Secondary outcomes (14)
Differences in the objective function values of the population-based models of CBD and THC when implementing bodyweight, age, and body composition factors as covariates on the pharmacokinetic parameters of the model (e.g., clearance)
The objective function value (minus two times the log-likelihood) describes the prediction accuracy (goodness-of-fit) of a population pharmacokinetic model. A drop in the objective function value of 6.63 in a model with one (1) added covariate implemented on any specific parameter compared to a base model corresponds to a significant improvement in model fit with a p-value of 0.01 in a chi-squared test.
Population-based pharmacokinetic-pharmacodynamic modelling is an analysis method performed on pharmacokinetic data, i.e. plasma concentrations over time, coupled to pharmacodynamic data. Relevant pharmacokinetic and -dynamic parameters are estimated simultaneously by fitting the data to the model. The model structure is found through the analysis and determines which pharmacokinetic and -dynamic parameters are estimated. As a minimum, the clearance and distribution volume of the central compartment are estimated
Measured: Trial days 1 and 2.
Difference in subjective appetite between Sativex® and placebo
Using combined subjective appetite scores measured using 100-mm Visual Analogue Scales (VAS), with 0.0 as the minimum value and 10.0 as the maximum value. The following will be used to calculate a combined appetite score: [desire to eat + hunger + prospective food consumption + (10.0 - fullness) + (10.0 - satiety)], with higher scores indicating better appetite.
Measured: Trial days 1 and 2.
Differences in the appetite hormones, total ghrelin and glucagon like peptide 1 (GLP-1) between Sativex® and placebo
The appetite hormones (total ghrelin, GLP-1) is measured from blood samples
Measured: Trial days 1 and 2.
Change in the intraocular pressure of the eye between Sativex® and placebo
Measured by Icare ic100 tanometer
Measured: Trial days 1 and 2.
Safety parameter (CNS effects) for Sativex®
Measured using 100-mm Visual Analogue Scales (VAS), with 0.0 as the minimum value and 10.0 as the maximum value. Higher scores indicate a larger effect.
Measured: Trial days 1 and 2.
Safety parameter (cognition) for Sativex®
Measured using Hopkins Verbal Learning Test-Revised for a total score of the following sub-tests: 'Total recall', 'Delayed recall', 'Retention' and 'Recognition'. Higher scores indicate better performance.
Measured: Trial days 1 and 2.
Safety parameter (balance disorders) for Sativex®
Bergs Balance Test is used to measure balance disorders. Balance disorders are defined as a summerated score of ≤45.
Measured: Trial days 1 and 2.
Safety parameter (blood pressure) for Sativex®
Blood pressure is measured in millimeter of mercury (mmHg) using automatic standardized equipment.
Measured: Trial days 1 and 2.
Safety parameter (heart rate) for Sativex®
Heart rate is measured in beats per minute (bpm) using automatic standardized equipment.
Measured: Trial days 1 and 2.
Correlation coefficient between clearance of gentamicin and clearance determined as mGFR or eGFR
Pharmacokinetic modeling
Measured: Trial day 3.
Change in plasma creatinine µmol/L between baseline and 22 hours after administration of gentamicin
Changes in kidney biomarkeres before and after administration of gentamicin
Measured: Trial day 3
Change in plasma cystatin C mg/L between baseline and 22 hours after administration of gentamicin
Changes in kidney biomarkers before and after administration of gentamicin
Measured: Trial day 3
Change in plasma NGAL ng/mL between baseline and 22 hours after administration of gentamicin
Changes in kidney biomarkers before and after administration of gentamicin
Measured: Trial day 3
Change in plasma KIM-1 pg/mL between baseline and 22 hours after administration of gentamicin
Changes in kidney biomarkers before and after administration of gentamicin
Measured: Trial day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start24 Mar 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ove Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Regionshospital Nordjylland, University of Copenhagen, Region Hovedstadens Apotek, Glostrup University Hospital, Copenhagen
- Responsible party
- Sponsor-investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, Study chair, Hvidovre University HospitalRikke L Nielsen, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503147
- Sponsor's protocol ID
- H-21044231
- Acronym
- CanPan
- Status last verified
- Sep 2022
- First submitted
- 13 Apr 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bornaes O, Nielsen RL, Christensen LWS, Storgaard IK, Kallemose T, Juul-Larsen HG, Tavenier J, Jawad B, Andersen O, Holst JJ, Hartmann B, Andersen AL, Poulsen I, Sonne DP, Houlind MB, Pedersen MM. Effects of Sativex(R) Versus Placebo on Glucagon-like Peptide-1, Total Ghrelin, and Subjective Appetite in Older Adults with Poor Appetite: A Protocolized Secondary Analysis of a Double-Blind, Randomized, Placebo-Controlled Crossover Trial. Nutrients. 2026 Jul 11;18(14):2274. doi: 10.3390/nu18142274.
PubMed 42514343Nielsen RL, Bornaes O, Christensen LWS, Juul-Larsen HG, Storgaard IK, Kallemose T, Jorgensen LM, Jawad BN, Altintas I, Lund TM, Rasmussen HH, Munk T, Andersen O, Houlind MB, Andersen AL. The appetite stimulating effect and safety of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in older patients with poor appetite: A triple-blinded, randomized, placebo-controlled, cross-over trial. Clin Nutr. 2025 Apr;47:248-257. doi: 10.1016/j.clnu.2025.02.024. Epub 2025 Feb 24.
PubMed 40069983
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacological Trial With Sativex® and Gentamicin for Optimized Phamacological Treatment of Older Patients With Focus on Appetite Stimulation and Renal Risk Drugs
- ClinicalTrials.gov ID
- NCT05503147
- Acronym / sponsor ID
- CanPan / H-21044231
- Conditions
- Malnutrition, Anorexia, Cannabis, Aging, Emergency Service, Hospital, Renal Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Ove AndersenUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Regionshospital Nordjylland, University of Copenhagen, Region Hovedstadens Apotek, Glostrup University Hospital, Copenhagen
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 16 Aug 2022 (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.
Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs.
The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.
Detailed description
The CanPan trial consists of sub study 1 and sub study 2. Subjects who meet all the inclusion criteria and none of the exclusion criteria are invited to participate in both sub studies. Sub study 1 consist of trial days 1 and 2 and sub study 2 consists of trial day 3.
Sub study 1:
Sub study 1 is a double-blinded, randomized, placebo-controlled, multidose, crossover trial that evaluates the appetite stimulating effect as well as the pharmacokinetics of Sativex®. The primary purpose of sub study 1 is to 1) uncover whether Sativex® has appetite stimulating properties defined as increased energy intake compared to placebo, 2) to develop a pharmacokinetic-pharmacodynamic model, and gain knowledge about the effect of Sativex® on other markers of appetite, the intraocular pressure of the eye and safety parameters.
In sub study 1, subjects receive both Sativex® and placebo. Both Sativex® and placebo are administered as an oromucosal spray. Sativex consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dose of spray (Cannabis sativa L. extract, cannabis leaf and flower). Subjects receive three dose of spray two times during a trial day. Trial day 1 is planned <14 days after inclusion and there is a 2-week break between trial days 1 and 2 due to a wash-out period. Follow-up visits/phonecalls are made on days 1, 2 and 7 after trial days 1 and 2.
Sub study 2:
Sub-study 2 is a single-dose pharmacokinetic study using gentamicin (Hexamycin®) as a renally excreted model drug. The purpose of sub study 2 is to compare the prediction accuracy of clearance estimates between eGFRpanel (creatinine-cystatinC-beta-2_microglobulin-beta_trace_protein, eGFRcomb (creatinine-cystatinC), eGFRcreatinine (creatinine), uCrCl (24-hour urine creatinine clearance) and mGFR (measured GFR) as covariates in population based pharmacokinetic modeling of gentamicin.
On trial day 3, gentamicin is used as the model substance for a drug that is excreted > 90% renally. Gentamicin is administered as a single dose of 5 mg/kg as an intravenous injection (bolus). The marketed drug, Hexamycin® (40 mg / mL), is used for this purpose. Trial day 3 is held within 4 weeks after trial day 2. Follow-up visits are made on day 1 and 2 after trial day 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sativex first (blinded) (3 dose of spray) | Experimental | Drug: SativexTrial day 1: Sativex (3 dose of spray x 2) Trial day 2: Placebo (3 dose of spray x 2) Trial day 3: Voluntary |
| Placebo first (blinded) (3 dose of spray) | Experimental | Drug: SativexTrial day 1: Placebo (3 dose of spray x 2) Trial day 2: Sativex (3 dose of spray x 2) Trial day 3: Voluntary |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥65 years of age
- Admitted to the acute medical department, Hvidovre Hospital
- Can cooperate cognitively and physically (patient reported)
- Low appetite/anorexia of ageing measures by SNAQ score ≤14
- BMI ≤30 (screening)
Key exclusion criteria (26 listed)
- Regular use of medical cannabis (patient reported)
- Use of medical cannabis within 14 days at baseline (patient reported)
- Recognized or suspected psychotic illness in the subject or the subjects family (medical record and patient report)
- Severe personality disorders (journal)
- Significant psychiatric disorder in addition to mild to moderate depression (medical record)
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 |
|---|---|---|
| SativexAlso: nabiximolsSativex® is administered as an oromucosal spray and consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dosis spray (Cannabis sativa L. extract, cannabis leaf and flower). The dose (3 sprays) is administered twice, at breakfast and lunch, respectively, with approximately 4 hours between each administration. | Drug | Placebo first (blinded) (3 dose of spray), Sativex first (blinded) (3 dose of spray) |
Primary outcome
Difference in energy intake (kJ) between Sativex® and placebo
Time frame: Trial days 1 and 2.
Measured at test meal
Differences in the objective function value of the population-based pharmacokinetic model when implementing renal clearance assessed by measured GFR (mL/min), or GFR estimates based on different endogenous markers, as covariates on gentamicin clearance
Time frame: Trial day 3.
The objective function value (minus two times the log-likelihood) describes the prediction accuracy (goodness-of-fit) of a population pharmacokinetic model. A drop in the objective function value of 6.63 in a model with one (1) added covariate implemented on any specific parameter compared to a base model corresponds to a significant improvement in model fit with a p-value of 0.01 in a chi-squared test. Population-based pharmacokinetic modelling is an analysis method performed on pharmacokinetic data, i.e., plasma concentrations over time. Relevant pharmacokinetic parameters are estimated simultaneously by fitting the data to the model. The model structure is found through the analysis and determines which pharmacokinetic parameters are estimated. As a minimum, the clearance and distribution volume of the central compartment are estimated
14 secondary outcomes
Differences in the objective function values of the population-based models of CBD and THC when implementing bodyweight, age, and body composition factors as covariates on the pharmacokinetic parameters of the model (e.g., clearance)
Time frame: Trial days 1 and 2.
Difference in subjective appetite between Sativex® and placebo
Time frame: Trial days 1 and 2.
Differences in the appetite hormones, total ghrelin and glucagon like peptide 1 (GLP-1) between Sativex® and placebo
Time frame: Trial days 1 and 2.
Change in the intraocular pressure of the eye between Sativex® and placebo
Time frame: Trial days 1 and 2.
Safety parameter (CNS effects) for Sativex®
Time frame: Trial days 1 and 2.
Safety parameter (cognition) for Sativex®
Time frame: Trial days 1 and 2.
Safety parameter (balance disorders) for Sativex®
Time frame: Trial days 1 and 2.
Safety parameter (blood pressure) for Sativex®
Time frame: Trial days 1 and 2.
Safety parameter (heart rate) for Sativex®
Time frame: Trial days 1 and 2.
Correlation coefficient between clearance of gentamicin and clearance determined as mGFR or eGFR
Time frame: Trial day 3.
Change in plasma creatinine µmol/L between baseline and 22 hours after administration of gentamicin
Time frame: Trial day 3
Change in plasma cystatin C mg/L between baseline and 22 hours after administration of gentamicin
Time frame: Trial day 3
Change in plasma NGAL ng/mL between baseline and 22 hours after administration of gentamicin
Time frame: Trial day 3
Change in plasma KIM-1 pg/mL between baseline and 22 hours after administration of gentamicin
Time frame: Trial day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 42514343Bornaes O, Nielsen RL, Christensen LWS, Storgaard IK, Kallemose T, Juul-Larsen HG, Tavenier J, Jawad B, Andersen O, Holst JJ, Hartmann B, Andersen AL, Poulsen I, Sonne DP, Houlind MB, Pedersen MM. Effects of Sativex(R) Versus Placebo on Glucagon-like Peptide-1, Total Ghrelin, and Subjective Appetite in Older Adults with Poor Appetite: A Protocolized Secondary Analysis of a Double-Blind, Randomized, Placebo-Controlled Crossover Trial. Nutrients. 2026 Jul 11;18(14):2274. doi: 10.3390/nu18142274.
- Derived from this study: PubMed 40069983Nielsen RL, Bornaes O, Christensen LWS, Juul-Larsen HG, Storgaard IK, Kallemose T, Jorgensen LM, Jawad BN, Altintas I, Lund TM, Rasmussen HH, Munk T, Andersen O, Houlind MB, Andersen AL. The appetite stimulating effect and safety of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in older patients with poor appetite: A triple-blinded, randomized, placebo-controlled, cross-over trial. Clin Nutr. 2025 Apr;47:248-257. doi: 10.1016/j.clnu.2025.02.024. Epub 2025 Feb 24.
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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.
Ove Andersen study chair
Hvidovre University Hospital
Rikke L Nielsen study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex in people with Malnutrition and Anorexia, run by Ove Andersen at 1 site in Denmark.
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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivia Bornæs (+4538623184, olivia.bornaes@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in energy intake (kJ) between Sativex® and placebo (time frame: Trial days 1 and 2.). The study lists 2 primary outcomes in all. 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 NCT05503147, which also lists 2 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 21 Sep 2022.