PreDiabetesNCT03419702
Almonds and Health Effects on Metabolism, Vascular Function and Cognition
A study testing Almonds in people with PreDiabetes and Impaired Glucose Tolerance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The primary objective of the proposed study is to examine and understand the impact of long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- PreDiabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose
- What is being tested?
- Almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2018to 3 Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40-70 years
- Men and women
- BMI between 25-35 kg/m2 (overweight and obese)
- Being classified as having impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG). IGT is defined according the criteria of the WHO and American Diabetes Association (ADA) as two-hour glucose concentrations of 7.8 to 11.0 mmol/l (140 to 199 mg per dL) during the 75-g oral glucose tolerance test. IFG is defined as having a fasting plasma glucose between 6.1 and 7.0 mmol/l (110 to 125 mg per dL) and a two-hour glucose concentration below 7.8 mmol/l (140 mg per dL).
- Serum total cholesterol < 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia [serum total cholesterol ≥ 8.0 mmol/L] according to the Standard for cardiovascular risk management of the Dutch general practitioners community [NHG])
- Serum triacylglycerol < 4.52 mmol/L
Show all 20Show fewer
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- Not more than 4 alcoholic consumption per day with a maximum of 21 per week
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention trial within the previous 1-month
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- Willing to comply to study protocol during study
- Informed consent signed
Who cannot join
- Allergy or intolerance to almonds
- Serum total cholesterol ≥ 8.0 mmol/L
- Serum triacylglycerol ≥ 4.52 mmol/L
- Current smoker, or smoking cessation <12 months
- Diabetic patients
- Familial hypercholesterolemia
Show all 19Show fewer
- Abuse of drugs
- More than 4 alcoholic consumptions per day or 21 per week
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use medication known to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
- Use of over-the-counter and prescribed medication or supplements, which may interfere with study measurements to be judged by the principal investigator;
- Use of oral antibiotics in 40 days or less prior to the start of the study;
- Blood donation in the past 3 months before the start of the study
- Not willing to comply to study protocol during study or sign informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University, Department of Nutrition and Movement Sciences
Maastricht, Limburg, 6200 MD
About this study
Official title: Effects of Almond Consumption on Chronic Glucose Regulation, Vascular Function and Cognitive Performance: The AL-INCLUSIVE Trial
The primary objective of the proposed study is to examine and understand the impact of long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose.
Read the detailed description
Objectives:
Secondary objectives are to investigate if improved chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose after long-term almond consumption translates into improved peripheral and brain vascular function, and enhanced cognitive performance. In addition, the investigators will address to what extent improved chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose after long-term almond consumption can be explained by (combined) effects of lowered hepatic lipid accumulation and inflammation, skeletal muscle characteristics, visceral and subcutaneous fat accumulation, pancreatic function or fecal microbiota composition.
Study design:
The proposed study will be a 12 months randomised, controlled trial with a cross-over design. Two experimental periods of five months will be separated by a two months washout period.
Study population:
Forty-three impaired glucose tolerant and/or impaired fasting glucose subjects, with overweight and mild obesity (BMI 25-35 kg/m2), aged 40-70 years.
Intervention:
During the intervention period of 5 months, subjects will receive daily 50 gr almonds, but not in the 2 months washout and 5 months control periods.
- Being tested
- Almonds
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
During the intervention period of 5 months, subjects will receive daily 50 gr almonds. Subjects are free to consume the almonds during the day whenever they want to, i.e. there will not be guidelines when to consume the almonds.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No almonds |
| Experimental | Experimental | Almonds Receives: Dietary Supplement: Almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Glucose infusion rate during a hyper-insulinemic euglycemic clamp.
Measured: Change from control period (week 22 and week 52)
Secondary outcomes (32)
Glucose concentrations
Fasting plasma glucose concentrations will be determined in blood samples.
Measured: Glucose will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Markers for fasting lipid metabolism
Markers for fasting lipid metabolism include serum total cholesterol (mmol/L), HDL cholesterol (mmol/L), and triacylglycerol (mmol/L) concentrations.
Measured: These markers will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
LDL cholesterol concentrations
Fasting LDL cholesterol concentrations will be determined in blood samples using the Friedewald equation.
Measured: These markers will be calculated from measurements at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
C-reactive protein concentrations
Concentrations of CRP will be determined in blood samples.
Measured: CRP will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Blood pressure
Systolic and diastolic blood pressure.
Measured: Blood pressure will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Body weight
Body weight in kg.
Measured: Body weight will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Body circumferences
Waist and hip circumferences.
Measured: Waist and hip circumferences will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Pulse Wave Analysis
Vascular function (arterial stiffness).
Measured: Change from control period (week 21 and week 51)
Pulse Wave Velocity
Vascular function (arterial stiffness).
Measured: Change from control period (week 21 and week 51)
Retinal microvascular caliber
Arteriovenous ratio and diameter of retinal arterioles and venules will be measured by retinal microvascular imaging.
Measured: Change from control period (week 21 and week 51)
Cognitive performance
Cambridge Neuropsychological Test Automated Battery.
Measured: Cognition will be tested at week 0, week 10, week 21, week 30, week 40, week 51.
Markers for low-grade systemic inflammation
Markers for low-grade systemic inflammation include IL-6, IL-8, TNF-alpha and SAA.
Measured: Change from control period (week 21 and week 51)
Markers for endothelial dysfunction
Markers for endothelial dysfunction include sVCAM-1, sICAM-1 and soluble E-selectin.
Measured: Change from control period (week 21 and week 51)
Markers for postprandial lipid metabolism
Markers for postprandial lipid metabolism include triacylglycerol (mmol/L) and NEFA concentrations.
Measured: Change from control period (week 21 and week 51)
Markers for fasting and postprandial glucose and insulin metabolism
Markers for fasting and postprandial glucose and insulin metabolism include plasma glucose, serum insulin, C-peptide and HbA1c concentrations. Also HOMA-IR will be calculated.
Measured: Change from control period (week 21 and week 51)
Markers for liver function
Markers for liver function include ALAT and ASAT concentrations.
Measured: Change from control period (week 21 and week 51)
Markers for nerve growth
Markers for nerve growth include BDNF concentrations.
Measured: Change from control period (week 21 and week 51)
Markers for advanced glycation endproducts
Markers for advanced glycation endproducts include dicarbonyl, CML, CEL and MG-H1 concentrations.
Measured: Change from control period (week 21 and week 51)
Nitric oxides concentrations
Concentrations of NOx will be determined in blood samples.
Measured: Change from control period (week 21 and week 51)
Cerebral blood flow
Arterial Spin labeling will be performed to determine cerebral blood flow.
Measured: Change from control period (week 22 and week 52)
Fat distribution in abdomen
Magnetic Resonance Imaging measurements will be included to quantify abdominal fat compartments (i.e. subcutaneous and visceral fat) and fat content of abdominal organs (i.e. liver and pancreas).
Measured: Change from control period (week 22 and week 52)
Biopsies adipose tissue
Fat biopsies to examine fat cell size and inflammation in adipose tissue.
Measured: Change from control period (week 22 and week 52)
Biopsies muscle tissue
Muscle biopsies to examine mitochondrial function.
Measured: Change from control period (week 22 and week 52)
Lipid oxidation
Energy expenditure and substrate metabolism will be calculated from measurements via indirect calorimetry during the postprandial test.
Measured: Indirect calorimetry will be performed at week 21, week 22, week 51, week 52 at several time slots.
Glucose oxidation
Energy expenditure and substrate metabolism will be calculated from measurements via indirect calorimetry during the postprandial test.
Measured: Indirect calorimetry will be performed at week 21, week 22, week 51, week 52 at several time slots.
Blood pressure profiles
Blood pressure profiles will be measured for 48 hr via a Mobil-O-Graph.
Measured: Change from control period (week 21 and week 51)
Glucose profiles
Glucose profiles will be measured for 48 hr using the FreeStyle Libre Pro.
Measured: Change from control period (week 21 and week 51)
Physical activity profiles
Physical activity patterns will be monitored for 48 hr with the MOX device.
Measured: Change from control period (week 21 and week 51)
Microbiota composition
Fecal samples to be used for analysing microbiota composition will be collected.
Measured: Change from control period (week 21 and week 51)
General well-being
Quality of life and Affect grid questionnaires will be assessed.
Measured: General well-being will be tested at week 0, week 10, week 21, week 30, week 40, week 51.
Food frequency
Food frequency questionnaire will be assessed.
Measured: Food frequency will be tested at week 0, week 10, week 21, week 30, week 40, week 51.
Skinfold measurements
Calliper testing for determining body fat composition.
Measured: Change from control period (week 22 and week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start10 Jan 2018
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
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 PreDiabetesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, PhD, Principal investigator, Maastricht UniversityRonald P Mensink, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419702
- Sponsor's protocol ID
- METC173015
- Status last verified
- Mar 2022
- First submitted
- 9 Jan 2018
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chavez-Alfaro MA, Mensink RP, Gravesteijn E, Joris PJ, Plat J. Effects of long-term almond consumption on markers for vascular function and cardiometabolic risk in men and women with prediabetes: results of a randomized, controlled cross-over trial. Eur J Nutr. 2024 Nov 15;64(1):7. doi: 10.1007/s00394-024-03510-y.
PubMed 39546040Gravesteijn E, Mensink RP, Plat J. The effects of long-term almond consumption on whole-body insulin sensitivity, postprandial glucose responses, and 48 h continuous glucose concentrations in males and females with prediabetes: a randomized controlled trial. Eur J Nutr. 2023 Sep;62(6):2661-2672. doi: 10.1007/s00394-023-03178-w. Epub 2023 May 31.
PubMed 37258943
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almond Consumption on Chronic Glucose Regulation, Vascular Function and Cognitive Performance: The AL-INCLUSIVE Trial
- ClinicalTrials.gov ID
- NCT03419702
- Acronym / sponsor ID
- METC173015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the proposed study is to examine and understand the impact of long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose.
Detailed description
Objectives:
Secondary objectives are to investigate if improved chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose after long-term almond consumption translates into improved peripheral and brain vascular function, and enhanced cognitive performance. In addition, the investigators will address to what extent improved chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose after long-term almond consumption can be explained by (combined) effects of lowered hepatic lipid accumulation and inflammation, skeletal muscle characteristics, visceral and subcutaneous fat accumulation, pancreatic function or fecal microbiota composition.
Study design:
The proposed study will be a 12 months randomised, controlled trial with a cross-over design. Two experimental periods of five months will be separated by a two months washout period.
Study population:
Forty-three impaired glucose tolerant and/or impaired fasting glucose subjects, with overweight and mild obesity (BMI 25-35 kg/m2), aged 40-70 years.
Intervention:
During the intervention period of 5 months, subjects will receive daily 50 gr almonds, but not in the 2 months washout and 5 months control periods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No almonds |
| Experimental | Experimental | Dietary Supplement: AlmondsAlmonds |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Aged between 40-70 years
- Men and women
- BMI between 25-35 kg/m2 (overweight and obese)
- Being classified as having impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG). IGT is defined according the criteria of the WHO and American Diabetes Association (ADA) as two-hour glucose concentrations of 7.8 to 11.0 mmol/l (140 to 199 mg per dL) during the 75-g oral glucose tolerance test. IFG is defined as having a fasting plasma glucose between 6.1 and 7.0 mmol/l (110 to 125 mg per dL) and a two-hour glucose concentration below 7.8 mmol/l (140 mg per dL).
- Serum total cholesterol < 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia [serum total cholesterol ≥ 8.0 mmol/L] according to the Standard for cardiovascular risk management of the Dutch general practitioners community [NHG])
Key exclusion criteria (19 listed)
- Allergy or intolerance to almonds
- Serum total cholesterol ≥ 8.0 mmol/L
- Serum triacylglycerol ≥ 4.52 mmol/L
- Current smoker, or smoking cessation <12 months
- Diabetic patients
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 |
|---|---|---|
| AlmondsDuring the intervention period of 5 months, subjects will receive daily 50 gr almonds. Subjects are free to consume the almonds during the day whenever they want to, i.e. there will not be guidelines when to consume the almonds. | Dietary supplement | Experimental |
Primary outcome
Insulin sensitivity
Time frame: Change from control period (week 22 and week 52)
Glucose infusion rate during a hyper-insulinemic euglycemic clamp.
32 secondary outcomes
Glucose concentrations
Time frame: Glucose will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Markers for fasting lipid metabolism
Time frame: These markers will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
LDL cholesterol concentrations
Time frame: These markers will be calculated from measurements at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
C-reactive protein concentrations
Time frame: CRP will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Blood pressure
Time frame: Blood pressure will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Body weight
Time frame: Body weight will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Body circumferences
Time frame: Waist and hip circumferences will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52
Pulse Wave Analysis
Time frame: Change from control period (week 21 and week 51)
Pulse Wave Velocity
Time frame: Change from control period (week 21 and week 51)
Retinal microvascular caliber
Time frame: Change from control period (week 21 and week 51)
Cognitive performance
Time frame: Cognition will be tested at week 0, week 10, week 21, week 30, week 40, week 51.
Markers for low-grade systemic inflammation
Time frame: Change from control period (week 21 and week 51)
Markers for endothelial dysfunction
Time frame: Change from control period (week 21 and week 51)
Markers for postprandial lipid metabolism
Time frame: Change from control period (week 21 and week 51)
Markers for fasting and postprandial glucose and insulin metabolism
Time frame: Change from control period (week 21 and week 51)
Markers for liver function
Time frame: Change from control period (week 21 and week 51)
Markers for nerve growth
Time frame: Change from control period (week 21 and week 51)
Markers for advanced glycation endproducts
Time frame: Change from control period (week 21 and week 51)
Nitric oxides concentrations
Time frame: Change from control period (week 21 and week 51)
Cerebral blood flow
Time frame: Change from control period (week 22 and week 52)
Fat distribution in abdomen
Time frame: Change from control period (week 22 and week 52)
Biopsies adipose tissue
Time frame: Change from control period (week 22 and week 52)
Biopsies muscle tissue
Time frame: Change from control period (week 22 and week 52)
Lipid oxidation
Time frame: Indirect calorimetry will be performed at week 21, week 22, week 51, week 52 at several time slots.
Glucose oxidation
Time frame: Indirect calorimetry will be performed at week 21, week 22, week 51, week 52 at several time slots.
Blood pressure profiles
Time frame: Change from control period (week 21 and week 51)
Glucose profiles
Time frame: Change from control period (week 21 and week 51)
Physical activity profiles
Time frame: Change from control period (week 21 and week 51)
Microbiota composition
Time frame: Change from control period (week 21 and week 51)
General well-being
Time frame: General well-being will be tested at week 0, week 10, week 21, week 30, week 40, week 51.
Food frequency
Time frame: Food frequency will be tested at week 0, week 10, week 21, week 30, week 40, week 51.
Skinfold measurements
Time frame: Change from control period (week 22 and week 52)
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 4 Mar 2022.
- Derived from this study: PubMed 39546040Chavez-Alfaro MA, Mensink RP, Gravesteijn E, Joris PJ, Plat J. Effects of long-term almond consumption on markers for vascular function and cardiometabolic risk in men and women with prediabetes: results of a randomized, controlled cross-over trial. Eur J Nutr. 2024 Nov 15;64(1):7. doi: 10.1007/s00394-024-03510-y.
- Derived from this study: PubMed 37258943Gravesteijn E, Mensink RP, Plat J. The effects of long-term almond consumption on whole-body insulin sensitivity, postprandial glucose responses, and 48 h continuous glucose concentrations in males and females with prediabetes: a randomized controlled trial. Eur J Nutr. 2023 Sep;62(6):2661-2672. doi: 10.1007/s00394-023-03178-w. Epub 2023 May 31.
- 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.
Jogchum Plat, PhD principal investigator
Maastricht University
Ronald P Mensink, PhD principal investigator
Maastricht 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 Almonds in people with PreDiabetes and Impaired Glucose Tolerance, run by Maastricht University Medical Center at 1 site in Netherlands.
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 20 inclusion and 19 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 4 Mar 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 Netherlands. 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?
Insulin sensitivity (time frame: Change from control period (week 22 and week 52)). 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 NCT03419702, 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 4 Mar 2022.