ObesityNCT05736432
Impacts of Wild Blueberries on Appetite and Weight Regulation
A study testing Blueberries in people with Obesity and Weight Loss, run by San Diego State University at 1 site in United States.
Trial summary
The objective is to complete a two-phase study to assess how wild blueberries impact regulation of appetite of overweight and obese men and women as well as to determine if wild blueberries can promote more effective weight loss than an isocaloric control. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Blueberries
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Feb 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or Obese (BMI 25-40)
Who cannot join
- Pregnancy
- Smoking
- >5 kg wt fluctuation in the past 3 months
- exercising > 2 times per week
- Medical conditions or medications that may affect body weight, metabolism, other outcome measures
- Allergy to blueberries or yogurt
- Already eating blueberries more than twice weekly
- Consumption of >50 g/d alcohol
Trial locations and contacts
1 site in 1 country.
United States1 site
Mark Kern, PhD, RD
San Diego, California, 92182-7251
About this study
The objective is to complete a two-phase study to assess how wild blueberries impact regulation of appetite of overweight and obese men and women as well as to determine if wild blueberries can promote more effective weight loss than an isocaloric control. For phase I, the acute effects of consuming 1-cup of frozen wild blueberries mixed into ¾ C of low-fat yogurt will be compared to consuming an isocaloric serving of yogurt mixed with an artificially flavored and colored blueberry syrup. During acute testing, subjective ratings of appetite, glucose metabolism, and appetite-regulating hormones will be assessed. Phase II will consist of an 8-week feeding trial in which the same subjects will consume daily servings of yogurt mixed with either frozen wild blueberries or placebo syrup along with intensive counseling for weight loss. The hypothesis is that wild blueberries will reduce hunger by regulating appetite hormones and promoting beneficial glycemic and insulinemic responses and that daily consumption of wild blueberries will translate to improved adherence to a weight loss regimen and therefore greater weight and fat loss. Secondary aims for Phase II of this project will include exploring the impacts of blueberry consumption during weight loss on antioxidant status, inflammatory markers, blood lipid profiles, glucose status, dietary intake, physical activity and blood pressure.
Read the detailed description
For Phase I, all subjects will complete two acute feeding trials in random order. One feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal). The other feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani). A standardized meal will be consumed the evening prior to testing to minimize fluctuations during the testing days. Arterialized fingerprick blood samples from heated hands will be collected into Greiner Bio-One MiniCollect™ Capillary Blood Collection System Tubes containing Ethylenediaminetetraacetic acid while fasted and 30, 60 and 120 minutes after food intake for analysis of glucose, insulin, ghrelin, and pancreatic peptide. Appetitive responses (hunger, fullness, desire to eat, and prospective food consumption) will be assessed by 100-mm visual analog scales at baseline and 15, 30, 45, 60, 90, and 120 minutes after intake.
For Phase II, subjects will be equally divided and matched for body fatness into two randomly assigned groups. Both groups will be counseled for weight loss, which will be achieved through a comprehensive program including a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale. In addition, groups will be randomly assigned to daily consume the same 170 kcal yogurt parfait described above containing either wild blueberries or placebo as an afternoon snack for 8 weeks. The rationale for the inclusion of a healthy, wild blueberry in yogurt afternoon snack intervention is supported by the National Health And Nutrition Examination Survey analyses that revealed a shift in eating patterns towards the evening in combination with an increase in snacking occasions, particularly in the afternoon/evening hours. Further, the majority of the snacking occasions include unhealthy, high fat/high sugar foods, potentially contributing to unwanted weight gain and obesity. Moreover, since blueberries can elevate pancreatic peptide for at least 2 hours after consumption, this could enhance the likelihood of maintaining lower intake during the evening meal. Thus, overall, it is proposed that the afternoon wild blueberry/yogurt snack will promote satiety and reduce overeating (especially of unhealthy foods) later in the day.
All participants will be counseled to achieve a 500-kcal/d energy deficit (from their baseline eucaloric diet). Energy requirements will be estimated by calculating resting metabolic rate using the equations of Schofield and multiplying by an activity factor of 1.3. The participants will meet with investigators every two-weeks for intensive counseling to ensure adherence to the dietary prescription. Before and after the trial, fasted blood will be collected into tubes for both plasma and serum to assess total antioxidant capacity, C-reactive protein, blood lipid concentrations, glucose and insulin. During lab visits investigators will assess anthropometrics (height, body weight, and body composition via dual x-ray absorptiometry, dietary intake, physical activity behaviors, food cravings, and blood pressure. Adequate samples of blood will be collected to allow us to bank plasma for future analyses if additional funding is obtained in the future.
- Conditions
- Obesity, Weight Loss
- Being tested
- Blueberries, Placebo
- Keywords
- Blueberries, Yogurt, Weight loss, Appetite
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberriesDietary supplement
Experimental condition
PlaceboDietary supplement
Placebo condition
| Study group | Role | What they receive |
|---|---|---|
| Blueberries-Phase I | Experimental | feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal) Receives: Dietary Supplement: Blueberries |
| Syrup-Phase I | Placebo comparator | feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani) Receives: Dietary Supplement: Placebo |
| Blueberries-Phase II | Experimental | 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal) along with a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale Receives: Dietary Supplement: Blueberries |
| Syrup-Phase II | Placebo comparator | isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani) along with a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose
fasted
Measured: 8 weeks
Total Cholesterol
Total Cholesterol
Measured: 8 weeks
Triglycerides
Triglycerides
Measured: 8 weeks
HDL-Cholesterol
HDL-Cholesterol
Measured: 8 weeks
Insulin
Insulin
Measured: 8 weeks
Ghrelin
Ghrelin
Measured: 8 weeks
Pancreatic peptide
Pancreatic peptide
Measured: 8 weeks
C-Reactive Protein
C-Reactive Protein
Measured: 8 weeks
Total Antioxidant Capacity
Colorimetric assay kit using blood serum
Measured: 8 weeks
Blood Pressure
Systolic and Diastolic
Measured: 8 weeks
Body Composition
Daily via bioimpedance Wifi Scales
Measured: 8 weeks
Body Composition
dual x-ray absorptiometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Nov 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirin Hooshmand, PhD, RD, Study director, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736432
- Sponsor's protocol ID
- HS-2023-001
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stote K, Corkum A, Sweeney M, Shakerley N, Kean T, Gottschall-Pass K. Postprandial Effects of Blueberry (Vaccinium angustifolium) Consumption on Glucose Metabolism, Gastrointestinal Hormone Response, and Perceived Appetite in Healthy Adults: A Randomized, Placebo-Controlled Crossover Trial. Nutrients. 2019 Jan 19;11(1):202. doi: 10.3390/nu11010202.
PubMed 30669469Molan AL, Lila MA, Mawson J. Satiety in rats following blueberry extract consumption induced by appetite-suppressing mechanisms unrelated to in vitro or in vivo antioxidant capacity. Food Chemistry. 2008 Apr 1;107(3):1039-44.
James LJ, Funnell MP, Milner S. An afternoon snack of berries reduces subsequent energy intake compared to an isoenergetic confectionary snack. Appetite. 2015 Dec;95:132-7. doi: 10.1016/j.appet.2015.07.005. Epub 2015 Jul 7.
PubMed 26162950DeFuria J, Bennett G, Strissel KJ, Perfield JW 2nd, Milbury PE, Greenberg AS, Obin MS. Dietary blueberry attenuates whole-body insulin resistance in high fat-fed mice by reducing adipocyte death and its inflammatory sequelae. J Nutr. 2009 Aug;139(8):1510-6. doi: 10.3945/jn.109.105155. Epub 2009 Jun 10.
PubMed 19515743Elks CM, Terrebonne JD, Ingram DK, Stephens JM. Blueberries improve glucose tolerance without altering body composition in obese postmenopausal mice. Obesity (Silver Spring). 2015 Mar;23(3):573-80. doi: 10.1002/oby.20926. Epub 2015 Jan 22.
PubMed 25611327Nair AR, Elks CM, Vila J, Del Piero F, Paulsen DB, Francis J. A blueberry-enriched diet improves renal function and reduces oxidative stress in metabolic syndrome animals: potential mechanism of TLR4-MAPK signaling pathway. PLoS One. 2014 Nov 5;9(11):e111976. doi: 10.1371/journal.pone.0111976. eCollection 2014.
PubMed 25372283Roopchand DE, Kuhn P, Rojo LE, Lila MA, Raskin I. Blueberry polyphenol-enriched soybean flour reduces hyperglycemia, body weight gain and serum cholesterol in mice. Pharmacol Res. 2013 Feb;68(1):59-67. doi: 10.1016/j.phrs.2012.11.008. Epub 2012 Dec 4.
PubMed 23220243Seymour EM, Tanone II, Urcuyo-Llanes DE, Lewis SK, Kirakosyan A, Kondoleon MG, Kaufman PB, Bolling SF. Blueberry intake alters skeletal muscle and adipose tissue peroxisome proliferator-activated receptor activity and reduces insulin resistance in obese rats. J Med Food. 2011 Dec;14(12):1511-8. doi: 10.1089/jmf.2010.0292. Epub 2011 Aug 23.
PubMed 21861718
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Wild Blueberries on Appetite and Weight Regulation
- ClinicalTrials.gov ID
- NCT05736432
- Acronym / sponsor ID
- HS-2023-001
- Conditions
- Obesity, Weight Loss
- Keywords
- Blueberries, Yogurt, Weight loss, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 21 Feb 2023 (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 objective is to complete a two-phase study to assess how wild blueberries impact regulation of appetite of overweight and obese men and women as well as to determine if wild blueberries can promote more effective weight loss than an isocaloric control. For phase I, the acute effects of consuming 1-cup of frozen wild blueberries mixed into ¾ C of low-fat yogurt will be compared to consuming an isocaloric serving of yogurt mixed with an artificially flavored and colored blueberry syrup. During acute testing, subjective ratings of appetite, glucose metabolism, and appetite-regulating hormones will be assessed. Phase II will consist of an 8-week feeding trial in which the same subjects will consume daily servings of yogurt mixed with either frozen wild blueberries or placebo syrup along with intensive counseling for weight loss. The hypothesis is that wild blueberries will reduce hunger by regulating appetite hormones and promoting beneficial glycemic and insulinemic responses and that daily consumption of wild blueberries will translate to improved adherence to a weight loss regimen and therefore greater weight and fat loss. Secondary aims for Phase II of this project will include exploring the impacts of blueberry consumption during weight loss on antioxidant status, inflammatory markers, blood lipid profiles, glucose status, dietary intake, physical activity and blood pressure.
Detailed description
For Phase I, all subjects will complete two acute feeding trials in random order. One feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal). The other feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani). A standardized meal will be consumed the evening prior to testing to minimize fluctuations during the testing days. Arterialized fingerprick blood samples from heated hands will be collected into Greiner Bio-One MiniCollect™ Capillary Blood Collection System Tubes containing Ethylenediaminetetraacetic acid while fasted and 30, 60 and 120 minutes after food intake for analysis of glucose, insulin, ghrelin, and pancreatic peptide. Appetitive responses (hunger, fullness, desire to eat, and prospective food consumption) will be assessed by 100-mm visual analog scales at baseline and 15, 30, 45, 60, 90, and 120 minutes after intake.
For Phase II, subjects will be equally divided and matched for body fatness into two randomly assigned groups. Both groups will be counseled for weight loss, which will be achieved through a comprehensive program including a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale. In addition, groups will be randomly assigned to daily consume the same 170 kcal yogurt parfait described above containing either wild blueberries or placebo as an afternoon snack for 8 weeks. The rationale for the inclusion of a healthy, wild blueberry in yogurt afternoon snack intervention is supported by the National Health And Nutrition Examination Survey analyses that revealed a shift in eating patterns towards the evening in combination with an increase in snacking occasions, particularly in the afternoon/evening hours. Further, the majority of the snacking occasions include unhealthy, high fat/high sugar foods, potentially contributing to unwanted weight gain and obesity. Moreover, since blueberries can elevate pancreatic peptide for at least 2 hours after consumption, this could enhance the likelihood of maintaining lower intake during the evening meal. Thus, overall, it is proposed that the afternoon wild blueberry/yogurt snack will promote satiety and reduce overeating (especially of unhealthy foods) later in the day.
All participants will be counseled to achieve a 500-kcal/d energy deficit (from their baseline eucaloric diet). Energy requirements will be estimated by calculating resting metabolic rate using the equations of Schofield and multiplying by an activity factor of 1.3. The participants will meet with investigators every two-weeks for intensive counseling to ensure adherence to the dietary prescription. Before and after the trial, fasted blood will be collected into tubes for both plasma and serum to assess total antioxidant capacity, C-reactive protein, blood lipid concentrations, glucose and insulin. During lab visits investigators will assess anthropometrics (height, body weight, and body composition via dual x-ray absorptiometry, dietary intake, physical activity behaviors, food cravings, and blood pressure. Adequate samples of blood will be collected to allow us to bank plasma for future analyses if additional funding is obtained in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blueberries-Phase I | Experimental | Dietary Supplement: Blueberriesfeeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal) |
| Syrup-Phase I | Placebo comparator | Dietary Supplement: Placebofeeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani) |
| Blueberries-Phase II | Experimental | Dietary Supplement: Blueberries1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal) along with a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale |
| Syrup-Phase II | Placebo comparator | Dietary Supplement: Placeboisocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani) along with a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight or Obese (BMI 25-40)
Key exclusion criteria (8 listed)
- Pregnancy
- Smoking
- >5 kg wt fluctuation in the past 3 months
- exercising > 2 times per week
- Medical conditions or medications that may affect body weight, metabolism, other outcome measures
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 |
|---|---|---|
| BlueberriesExperimental condition | Dietary supplement | Blueberries-Phase I, Blueberries-Phase II |
| PlaceboPlacebo condition | Dietary supplement | Syrup-Phase I, Syrup-Phase II |
Primary outcome
Plasma Glucose
Time frame: 8 weeks
fasted
Total Cholesterol
Time frame: 8 weeks
Total Cholesterol
Triglycerides
Time frame: 8 weeks
Triglycerides
HDL-Cholesterol
Time frame: 8 weeks
HDL-Cholesterol
Insulin
Time frame: 8 weeks
Insulin
Ghrelin
Time frame: 8 weeks
Ghrelin
Pancreatic peptide
Time frame: 8 weeks
Pancreatic peptide
C-Reactive Protein
Time frame: 8 weeks
C-Reactive Protein
Total Antioxidant Capacity
Time frame: 8 weeks
Colorimetric assay kit using blood serum
Blood Pressure
Time frame: 8 weeks
Systolic and Diastolic
Body Composition
Time frame: 8 weeks
Daily via bioimpedance Wifi Scales
Body Composition
Time frame: 8 weeks
dual x-ray absorptiometry
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 Feb 2025.
- Background: PubMed 30669469Stote K, Corkum A, Sweeney M, Shakerley N, Kean T, Gottschall-Pass K. Postprandial Effects of Blueberry (Vaccinium angustifolium) Consumption on Glucose Metabolism, Gastrointestinal Hormone Response, and Perceived Appetite in Healthy Adults: A Randomized, Placebo-Controlled Crossover Trial. Nutrients. 2019 Jan 19;11(1):202. doi: 10.3390/nu11010202.
- BackgroundMolan AL, Lila MA, Mawson J. Satiety in rats following blueberry extract consumption induced by appetite-suppressing mechanisms unrelated to in vitro or in vivo antioxidant capacity. Food Chemistry. 2008 Apr 1;107(3):1039-44.
- Background: PubMed 26162950James LJ, Funnell MP, Milner S. An afternoon snack of berries reduces subsequent energy intake compared to an isoenergetic confectionary snack. Appetite. 2015 Dec;95:132-7. doi: 10.1016/j.appet.2015.07.005. Epub 2015 Jul 7.
- Background: PubMed 19515743DeFuria J, Bennett G, Strissel KJ, Perfield JW 2nd, Milbury PE, Greenberg AS, Obin MS. Dietary blueberry attenuates whole-body insulin resistance in high fat-fed mice by reducing adipocyte death and its inflammatory sequelae. J Nutr. 2009 Aug;139(8):1510-6. doi: 10.3945/jn.109.105155. Epub 2009 Jun 10.
- Background: PubMed 25611327Elks CM, Terrebonne JD, Ingram DK, Stephens JM. Blueberries improve glucose tolerance without altering body composition in obese postmenopausal mice. Obesity (Silver Spring). 2015 Mar;23(3):573-80. doi: 10.1002/oby.20926. Epub 2015 Jan 22.
- Background: PubMed 25372283Nair AR, Elks CM, Vila J, Del Piero F, Paulsen DB, Francis J. A blueberry-enriched diet improves renal function and reduces oxidative stress in metabolic syndrome animals: potential mechanism of TLR4-MAPK signaling pathway. PLoS One. 2014 Nov 5;9(11):e111976. doi: 10.1371/journal.pone.0111976. eCollection 2014.
- Background: PubMed 23220243Roopchand DE, Kuhn P, Rojo LE, Lila MA, Raskin I. Blueberry polyphenol-enriched soybean flour reduces hyperglycemia, body weight gain and serum cholesterol in mice. Pharmacol Res. 2013 Feb;68(1):59-67. doi: 10.1016/j.phrs.2012.11.008. Epub 2012 Dec 4.
- Background: PubMed 21861718Seymour EM, Tanone II, Urcuyo-Llanes DE, Lewis SK, Kirakosyan A, Kondoleon MG, Kaufman PB, Bolling SF. Blueberry intake alters skeletal muscle and adipose tissue peroxisome proliferator-activated receptor activity and reduces insulin resistance in obese rats. J Med Food. 2011 Dec;14(12):1511-8. doi: 10.1089/jmf.2010.0292. Epub 2011 Aug 23.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Shirin Hooshmand, PhD, RD study director
San Diego State 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 Blueberries in people with Obesity and Weight Loss, run by San Diego State 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 1 inclusion and 8 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 Feb 2025. 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?
Plasma Glucose (time frame: 8 weeks). The study lists 12 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 NCT05736432, which also lists 8 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 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.