Cardiovascular Risk FactorMACNCT03801837
Effect of Macadamia Nut on Cardiometabolic Risk Factors
A study testing Macadamia Nut in people with Cardiovascular Risk Factor and Heart Diseases, run by Loma Linda University at 1 site in United States.
Trial summary
This research study will test the effects of macadamia nuts on adiposity, and traditional and emergent risk factors of cardiometabolic disease in adult men and women Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Heart Diseases, Inflammation
- What is being tested?
- Macadamia Nut
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 25 Nov 2019
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and post-menopausal women
- Overweight (BMI 25-<40)
- Waist circumference ≥88.9 cm for women and ≥101.6 cm for men
- At least one of the following within the past year:
- Plasma triglycerides ≥150mg/dl
- Blood Pressure ≥130/85 mmHg or participants taking Antihypertensive medication
- Fasting glucose ≥100 mg/dL
- Low Density Lipoproteins>= 130 mg/dl
Who cannot join
- Nut allergy, any
- Significant chronic disease including: diabetes, congestive heart failure, renal failure, cirrhosis, or autoimmune disease
- Medications affecting lipid or glucose metabolism, immune modulators, or antibiotics in the last 6 months
- Mega-doses of lipid-lowering dietary supplements in the last 6 months
- Cancer in the last 10 years (with the exception on non-melanoma skin cancer)
- Pregnancy or lactation
Show all 9Show fewer
- Weight change of >10% of body weight in the last 3 months.
- Tobacco use
- Claustrophobia (may affect BOD POD testing)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors
This research study will test the effects of macadamia nuts on adiposity, and traditional and emergent risk factors of cardiometabolic disease in adult men and women
Read the detailed description
Purpose of this study is to investigate the effects of Macadamia nuts on body weight, adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross over study that will include two study diets (Macadamia nut diet and control diet) with a wash out period of 4 weeks in between. 40 subjects will be selected and randomized into either of the two phases. During the Macadamia nut diet phase subjects will be provided the appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal requirement of the individual, instructions will be provided on how to incorporate nuts into the diet. this phase will last for 8 weeks. During the control diet phase, subjects will continue with their normal diet and abstain from eating nuts. subjects will be tested for various outcomes at baseline and twice at the end of each phase. The intervention will last for 5 months in total.
- Conditions
- Cardiovascular Risk Factor, Heart Diseases, Inflammation
- Being tested
- Macadamia Nut, Control Diet
- Keywords
- Macadamia Nuts, Cardiovascular Disease, Inflammation
- Medical subject headings
- Heart Diseases, Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macadamia NutDietary supplement
Participants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual]
Control DietDietary supplement
Participants will continue with their Habitual Diet during this part of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Macadamia Nut Diet | Active comparator | This group will have their habitual diet supplemented with appropriate portion of Macadamia Nuts (15% of daily calories or 30-45 grams based on Kcal requirement of the individual) Receives: Dietary Supplement: Macadamia Nut |
| Control Diet | Placebo comparator | This group will continue with their Habitual Diet Receives: Dietary Supplement: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight
The objective of this measure is to see if eating macadamia nuts could reduce body weight. An In body machine will be used to identify this by measuring the weight of the participants at the baseline and at the end of each diet phase. The weight will be measured in Kilograms
Measured: baseline to 18 weeks
change in body adiposity
The objective of this measure is to see if eating Macadamia Nuts could reduce percentage body fat. Air Displacement Plethysmography will be used to determine any change in body percentage fat at the baseline and end of each diet phase
Measured: baseline to 18 weeks
change in body fat mass
The objective of this measure is to see if eating Macadamia nuts could change body fat mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
Measured: baseline to 18 weeks
change in body percentage fat
The objective of this measure is to see if eating Macadamia nuts could change body percentage fat at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
Measured: baseline to 18 weeks
change in total body water
The objective of this measure is to see if eating Macadamia nuts could change total body water at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
Measured: baseline to 18 weeks
change in skeletal muscle mass
The objective of this measure is to see if eating Macadamia nuts could change skeletal muscle mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
Measured: baseline to 18 weeks
change in lean body mass
The objective of this measure is to see if eating Macadamia nuts could change lean body mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
Measured: baseline to 18 weeks
change in dry lean mass
The objective of this measure is to see if eating Macadamia nuts could change dry lean mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
Measured: baseline to 18 weeks
change in fasting plasma cholesterol (mg/dl)
change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent
Measured: baseline to 18 weeks
change in fasting plasma low density lipoprotein cholesterol (mg/dl)
change in fasting plasma low density lipoprotein cholesterol (mg/dl) will be estimated by the use of a two reagent calorimetric enzymatic homogeneous system on the AU480 clinical chemistry analyzer
Measured: baseline to 18 weeks
change in fasting plasma high density lipoprotein cholesterol (mg/dl)
change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection
Measured: baseline to 18 weeks
change in fasting plasma triglycerides(mg/dl)
change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method
Measured: baseline to 18 weeks
change in serum apolipoprotein B (mg/dl)
change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
Measured: baseline to 18 weeks
change in serum apolipoprotein A1 (mg/dl)
change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
Measured: baseline to 18 weeks
change in serum small density low density lipoprotein cholesterol (mg/dl)
change in serum small density low density lipoprotein cholesterol (mg/dl) will be measured using a two reagent calorimetric enzymatic homogenous system on the AU480 clinical chemistry analyzer.
Measured: baseline to 18 weeks
change in serum oxidized low density lipoprotein (mg/dl)
change in serum oxidized low density lipoprotein (mg/dl) will be measured using a sandwich enzyme-linked immunosorbent assay, Human oxidized low density lipoprotein enzyme linked immunosorbent assay kit
Measured: baseline to 18 weeks
change in fasting plasma glucose
change in fasting plasma glucose levels (mg/dl) will be measured on a clinical chemistry analyzer,AU480 Clinical Chemistry Analyzer, (Beckman Coulter, Inc., Diagnostics Division Headquarters, Brea CA 92821.)
Measured: baseline to 18 weeks
change in fasting plasma insulin
change in fasting plasma insulin (uIU/ml) will be measured measured by solid-phase, two-site chemiluminescent immunometric assays using the IMMULITE 2000, (Siemens Healthcare Diagnostics, Los Angeles, CA 90045)
Measured: baseline to 18 weeks
change in insulin resistance
change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)
Measured: baseline to 18 weeks
Secondary outcomes (9)
effect modification of adiposity
The objective of this measure is to determine if adiposity is an effect modifier of low density lipoprotein cholesterol, lowering the effect of the macadamia nut intake. The test of this interaction will be performed using statistical analysis system (SAS) software
Measured: baseline to 18 weeks
change in serum Interleukin -6
change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
Measured: baseline to 18 weeks
change in serum tumor necrosis factor alpha
change in serum tumor necrosis factor alpha (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
Measured: baseline to 18 weeks
change in serum soluble selectin (ng/ml)
change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
Measured: baseline to 18 weeks
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)
Measured: baselline to 18 weeks
change in serum soluble -vascular adhesion molecule 1 (ng/dl)
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)
Measured: baselline to 18 weeks
change in C reactive protein
change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA)
Measured: baseline to 18 weeks
change in Malondialdehyde
change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay
Measured: baseline to 18 weeks
change in Prostaglandin F2 alpha
change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay
Measured: baseline to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start24 Jun 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
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.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabate, DrPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801837
- Sponsor's protocol ID
- 5190008
- Acronym
- MAC
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2019
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones JL, Sabate J, Heskey C, Oda K, Miles F, Rajaram S. Macadamia nut effects on cardiometabolic risk factors: a randomised trial. J Nutr Sci. 2023 May 8;12:e55. doi: 10.1017/jns.2023.39. eCollection 2023.
PubMed 37180485
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT03801837
- Acronym / sponsor ID
- MAC / 5190008
- Conditions
- Cardiovascular Risk Factor, Heart Diseases, Inflammation
- Keywords
- Macadamia Nuts, Cardiovascular Disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 14 Jan 2019 (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 research study will test the effects of macadamia nuts on adiposity, and traditional and emergent risk factors of cardiometabolic disease in adult men and women
Detailed description
Purpose of this study is to investigate the effects of Macadamia nuts on body weight, adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross over study that will include two study diets (Macadamia nut diet and control diet) with a wash out period of 4 weeks in between. 40 subjects will be selected and randomized into either of the two phases. During the Macadamia nut diet phase subjects will be provided the appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal requirement of the individual, instructions will be provided on how to incorporate nuts into the diet. this phase will last for 8 weeks. During the control diet phase, subjects will continue with their normal diet and abstain from eating nuts. subjects will be tested for various outcomes at baseline and twice at the end of each phase. The intervention will last for 5 months in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macadamia Nut Diet | Active comparator | Dietary Supplement: Macadamia NutThis group will have their habitual diet supplemented with appropriate portion of Macadamia Nuts (15% of daily calories or 30-45 grams based on Kcal requirement of the individual) |
| Control Diet | Placebo comparator | Dietary Supplement: Control DietThis group will continue with their Habitual Diet |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy men and post-menopausal women
- Overweight (BMI 25-<40)
- Waist circumference ≥88.9 cm for women and ≥101.6 cm for men
- At least one of the following within the past year:
- Plasma triglycerides ≥150mg/dl
Key exclusion criteria (9 listed)
- Nut allergy, any
- Significant chronic disease including: diabetes, congestive heart failure, renal failure, cirrhosis, or autoimmune disease
- Medications affecting lipid or glucose metabolism, immune modulators, or antibiotics in the last 6 months
- Mega-doses of lipid-lowering dietary supplements in the last 6 months
- Cancer in the last 10 years (with the exception on non-melanoma skin cancer)
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 |
|---|---|---|
| Macadamia NutParticipants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual] | Dietary supplement | Macadamia Nut Diet |
| Control DietParticipants will continue with their Habitual Diet during this part of the intervention | Dietary supplement | Control Diet |
Primary outcome
change in body weight
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating macadamia nuts could reduce body weight. An In body machine will be used to identify this by measuring the weight of the participants at the baseline and at the end of each diet phase. The weight will be measured in Kilograms
change in body adiposity
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia Nuts could reduce percentage body fat. Air Displacement Plethysmography will be used to determine any change in body percentage fat at the baseline and end of each diet phase
change in body fat mass
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia nuts could change body fat mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
change in body percentage fat
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia nuts could change body percentage fat at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
change in total body water
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia nuts could change total body water at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
change in skeletal muscle mass
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia nuts could change skeletal muscle mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
change in lean body mass
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia nuts could change lean body mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
change in dry lean mass
Time frame: baseline to 18 weeks
The objective of this measure is to see if eating Macadamia nuts could change dry lean mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method.
change in fasting plasma cholesterol (mg/dl)
Time frame: baseline to 18 weeks
change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent
change in fasting plasma low density lipoprotein cholesterol (mg/dl)
Time frame: baseline to 18 weeks
change in fasting plasma low density lipoprotein cholesterol (mg/dl) will be estimated by the use of a two reagent calorimetric enzymatic homogeneous system on the AU480 clinical chemistry analyzer
change in fasting plasma high density lipoprotein cholesterol (mg/dl)
Time frame: baseline to 18 weeks
change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection
change in fasting plasma triglycerides(mg/dl)
Time frame: baseline to 18 weeks
change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method
change in serum apolipoprotein B (mg/dl)
Time frame: baseline to 18 weeks
change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
change in serum apolipoprotein A1 (mg/dl)
Time frame: baseline to 18 weeks
change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
change in serum small density low density lipoprotein cholesterol (mg/dl)
Time frame: baseline to 18 weeks
change in serum small density low density lipoprotein cholesterol (mg/dl) will be measured using a two reagent calorimetric enzymatic homogenous system on the AU480 clinical chemistry analyzer.
change in serum oxidized low density lipoprotein (mg/dl)
Time frame: baseline to 18 weeks
change in serum oxidized low density lipoprotein (mg/dl) will be measured using a sandwich enzyme-linked immunosorbent assay, Human oxidized low density lipoprotein enzyme linked immunosorbent assay kit
change in fasting plasma glucose
Time frame: baseline to 18 weeks
change in fasting plasma glucose levels (mg/dl) will be measured on a clinical chemistry analyzer,AU480 Clinical Chemistry Analyzer, (Beckman Coulter, Inc., Diagnostics Division Headquarters, Brea CA 92821.)
change in fasting plasma insulin
Time frame: baseline to 18 weeks
change in fasting plasma insulin (uIU/ml) will be measured measured by solid-phase, two-site chemiluminescent immunometric assays using the IMMULITE 2000, (Siemens Healthcare Diagnostics, Los Angeles, CA 90045)
change in insulin resistance
Time frame: baseline to 18 weeks
change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)
9 secondary outcomes
effect modification of adiposity
Time frame: baseline to 18 weeks
change in serum Interleukin -6
Time frame: baseline to 18 weeks
change in serum tumor necrosis factor alpha
Time frame: baseline to 18 weeks
change in serum soluble selectin (ng/ml)
Time frame: baseline to 18 weeks
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)
Time frame: baselline to 18 weeks
change in serum soluble -vascular adhesion molecule 1 (ng/dl)
Time frame: baselline to 18 weeks
change in C reactive protein
Time frame: baseline to 18 weeks
change in Malondialdehyde
Time frame: baseline to 18 weeks
change in Prostaglandin F2 alpha
Time frame: baseline to 18 weeks
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 21 Mar 2023.
- Derived from this study: PubMed 37180485Jones JL, Sabate J, Heskey C, Oda K, Miles F, Rajaram S. Macadamia nut effects on cardiometabolic risk factors: a randomised trial. J Nutr Sci. 2023 May 8;12:e55. doi: 10.1017/jns.2023.39. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Risk Factor
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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.
Joan Sabate, DrPH principal investigator
Loma Linda 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 Macadamia Nut in people with Cardiovascular Risk Factor and Heart Diseases, run by Loma Linda University at 1 site in United States.
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 8 inclusion and 9 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 21 Mar 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 States. 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?
change in body weight (time frame: baseline to 18 weeks). The study lists 19 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 NCT03801837, 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 21 Mar 2023.