Metabolic SyndromeDSNFMETSPHNCT06729008
Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome
A study testing Diabetes-specific nutrition formula (DSNF) and Medical Nutrition Therapy in people with Metabolic Syndrome, run by St. Luke's Medical Center, Philippines.
Trial summary
INTRODUCTION: Metabolic syndrome, a cluster of metabolic abnormalities, is a growing global health concern, particularly in the Asia-Pacific region. The Philippines has seen a significant rise in metabolic syndrome prevalence, linked to lifestyle factors and socioeconomic changes. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Diabetes-specific nutrition formula (DSNF) and Medical Nutrition Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- An employee of St. Luke's Medical Center Global City for at least 1 year
- Of Filipino descent
- Aged 19-65 years
- Diagnosed with metabolic syndrome74 for at least 3 months, one of the criteria must include central obesity (WC of ≥90cm in Asian men, ≥80cm in Asian women)
- If being treated with a stable dose of medications for metabolic syndrome for ≥ 1 month, must only be among the following: i. Oral hypoglycemic agents (OHAs) (drugs permitted include Metformin, Sulfonylureas, Thiazolidinedione, Dipeptidyl Peptidase-IV Inhibitors, Glucagon-Like Peptide-1 Agonists) ii. Anti-hypertensive medications (drugs permitted include Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers, Calcium Channel Blockers) iii. Medications treating dyslipidemia (drugs permitted include Statins, Fibrates, Ezetimibe)
- BMI of 23 kg/m2 or more
- Willingness to adhere to study protocol
Who cannot join
- Serious illness requiring medical attention within past year (active malignancy, HIV/AIDS, cardiovascular, respiratory, renal, or hepatic diseases)
- Use of medications affecting plasma glucose within 3 months (corticosteroids, diuretics, beta-blockers, antipsychotics, and HIV medications)
- Insulin use
- Severe hypoglycemia or hyperglycemia requiring hospitalization within past year
- Surgery or hospitalization within past 2-3 months
- Anemia and/or blood transfusion within the last 3 months
Show all 15Show fewer
- History of gastrointestinal disease/surgery affecting product consumption/absorption (inflammatory bowel disease/bowel resection, another specifies gastroparesis, malabsorption, bariatric surgery, short bowel syndrome)
- Use of other diabetes-specific formulas prior to this study
- Use of nutritional food supplements or multivitamin supplements (specifically calcium/vitamin D supplements and B complex syrups) within 15 days before study initiation
- Psychiatric disorder impairing study adherence (eating disorders, severe dementia, delirium, significant neurological/psychiatric disorder)
- Pregnancy/ lactation
- Allergy/intolerance to study product components (INGREDIENTS : Maltodextrin, VEGETABLE OIL (high oleic sunflower oil, soy oil), calcium caseinate, sucromalt, isolated soy protein, maltitol, milk protein concentrate (cow's milk), MINERALS (potassium chloride, magnesium sulfate, calcium carbonate, potassium citrate, sodium phosphate, sodium chloride, magnesium phosphate, sodium citrate, potassium hydroxide, zinc sulfate, ferrous sulfate, manganese sulfate, copper sulfate, chromium chloride, potassium iodide, sodium molybdate, sodium selenite), fructose, fructo-oligosaccharides, isomaltulose, myo-inositol, oat fiber, flavoring, emulsifier (carboxymethyl cellulose), choline chloride, emulsifier (soy lecithin), stabiliser (xanthan gum), VITAMINS (ascorbyl palmitate, ascorbic acid, Vitamin E, niacinamide, calcium d-pantothenate, pyridoxine hydrochloride, thiamin chloride hydrochloride, riboflavin, Vitamin A palmitate, folic acid, phylloquinone, d-biotin, cholecalciferol, cyanocobalamin), taurine, L-carnitine, mixed tocopherols. Contains permitted flavouring substance. Contains stabilisers and emulsifiers as permitted food conditioners.)
- Weight loss/gain ≥ 5 kg within 6 weeks of starting the study
- Planning to start any form of calorie-restricted diet
- Alcoholism/substance use
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome: a Randomized Crossover Trial
INTRODUCTION: Metabolic syndrome, a cluster of metabolic abnormalities, is a growing global health concern, particularly in the Asia-Pacific region. The Philippines has seen a significant rise in metabolic syndrome prevalence, linked to lifestyle factors and socioeconomic changes. This condition increases the risk of serious health issues like type 2 diabetes, cardiovascular disease, and mortality. Lifestyle modifications, including dietary interventions, are crucial for managing metabolic syndrome. While dietary recommendations exist, practical challenges hinder their implementation. Diabetes-specific nutrition formulas (DSNFs) offer a convenient and effective solution, especially for individuals with limited cooking skills or knowledge. While DSNFs show promise in managing diabetes, their impact on metabolic syndrome remains unclear. This study aims to investigate the effects of DSNF on the metabolic parameters of Filipino adults with metabolic syndrome.
METHODS: This open-label randomized crossover trial will be conducted at St. Luke's Medical Center Global City. Filipino adults aged 19-65 with metabolic syndrome will be recruited. Participants will be randomized to either a 90-day intervention phase (DSNF) with a 14-day washout period or a 90-day control phase. After the initial phase, participants will cross over to the alternate phase. The primary outcome will be the change in metabolic parameters in the metabolic syndrome criteria (fasting blood sugar, triglycerides, HDL cholesterol, blood pressure, and waist circumference). Secondary outcomes include changes in metabolic parameters related to the metabolic syndrome (glycosylated hemoglobin, total cholesterol, LDL cholesterol, body weight, BMI, body composition), and safety and tolerability of the treatments. Participants will be monitored through regular follow-up visits, daily food diaries, and subjective assessments. Data will be analyzed using appropriate statistical methods.
- Conditions
- Metabolic Syndrome
- Being tested
- Diabetes-specific nutrition formula (DSNF), Medical Nutrition Therapy
- Keywords
- Metabolic Syndrome, Diabetes-Specific Nutrition Formula, Philippines
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes-specific nutrition formula (DSNF)Dietary supplement
The diabetes-specific nutrition formula to be used in this study will be Glucerna (Abbott Laboratories). It features an advanced blend of low-glycemic carbohydrates for steady energy release, a dual fiber blend to support digestive health, and a unique lipid blend free from trans fats, cholesterol, and low in saturated fat. Additionally, Glucerna is enriched with 4x more inositol and high levels of trivalent chromium, which contribute to maintaining normal blood glucose levels. It provides 28 essential vitamins and minerals, is low in lactose, and gluten-free, making it a suitable option for various dietary needs. 5 scoops will be mixed in 200 mL of water, and this amounts to 228 calories, with 30.01g of carbohydrates, 10.16g of protein, and 8.70g of fat. This will be given twice, as a breakfast replacement and an afternoon snack replacement.
Medical Nutrition TherapyOther
Also called MNT
Medical Nutrition Therapy is the standard of care for the management of metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| DSNF + MNT | Experimental | Not described Receives: Dietary Supplement: Diabetes-specific nutrition formula (DSNF); Other: Medical Nutrition Therapy |
| MNT | Active comparator | Not described Receives: Other: Medical Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline to post-intervention in fasting blood sugar
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: fasting blood sugar, measured in mg/dL.
Measured: 3 months
change from baseline to post-intervention in HDL cholesterol
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: HDL cholesterol, measured in mg/dL.
Measured: 3 months
change from baseline to post-intervention in serum triglycerides
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: serum triglycerides, measured in mg/dL.
Measured: 3 months
change from baseline to post-intervention in systolic blood pressure
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: systolic blood pressure, measured in mmHg.
Measured: 3 months
change from baseline to post-intervention in diastolic blood pressure
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: diastolic blood pressure, measured in mmHg.
Measured: 3 months
change from baseline to post-intervention in waist circumference
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: waist circumference, measured in centimeters.
Measured: 3 months
Secondary outcomes (9)
change from baseline to post-intervention in glycosylated hemoglobin
The secondary outcome measures of this study are the change from baseline to post-intervention in the following parameter related to metabolic syndrome: glycosylated hemoglobin, measured as a percentage of total hemoglobin.
Measured: 3 months
change from baseline to post-intervention in LDL cholesterol
The secondary outcome measures of this study are the change from baseline to post-intervention in the following parameter related to metabolic syndrome: LDL cholesterol, measured in mg/dL.
Measured: 3 months
change from baseline to post-intervention in total cholesterol
The secondary outcome measures of this study are the change from baseline to post-intervention in the following parameter related to metabolic syndrome: total cholesterol, measured in mg/dL.
Measured: 3 months
change from baseline to post-intervention in body weight
The secondary outcome measures of this study are the change from baseline to post-intervention in the following parameter related to metabolic syndrome: body weight, measured in kilograms.
Measured: 3 months
change from baseline to post-intervention in body mass index
The secondary outcome measures of this study are the change from baseline to post-intervention in the following parameter related to metabolic syndrome: body mass index, measured in kg/m^2.
Measured: 3 months
Adverse events related to the DSNF
Adverse events related to the DSNF such as diarrhea, constipation, abdominal distension, bloating, nausea, vomiting, and flatulence
Measured: 3 months
Satiety scale
A visual analog scale called the SLIM scale (satiety labeled intensity magnitude scale) will assess participants' subjective feelings of fullness or satiety. This will also be asked daily per meal via Google Forms. The SLIM scale is a vertical line anchored by "greatest imaginable fullness" at one end at 100mm, and "greatest imaginable hunger" at the other at -100mm. Descriptive phrases indicating various hunger and fullness levels are placed along the scale.
Measured: 3 months
DSNF Compliance
Compliance with the DSNF will be determined by reviewing the participants' daily food diary and returned product cans. 1 can contains 35 scoops. The compliance percentage will be calculated as: (number of scoops consumed per day/ number of scoops prescribed per day) * 100. This will also be counterchecked by counting the number of scoops in the returned product cans.
Measured: 3 months
Participants' perception of DSNF
This will be assessed using a 9-point hedonic scale. The 9-point hedonic scale will consist of "dislike extremely", "dislike very much", "dislike moderately", "dislike slightly", "neither like nor dislike", "like slightly", "like moderately", "like very much", and "like extremely". In addition to the hedonic scale, an open-ended question will be included to allow participants to express their thoughts and opinions about the product.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Feb 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Medical Center, Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelica Marie Real, St. Luke's Medical Center, Philippines
- Investigators
- Joy Arabelle C Fontanilla, Doctor of Medicine, Principal investigator, St. Luke's Medical Center, PhilippinesMaria Patricia Deanna D Maningat, Doctor of Medicine, Principal investigator, St. Luke's Medical Center, PhilippinesSahra May O Paragas, Doctor of Medicine, Principal investigator, St. Luke's Medical Center, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729008
- Sponsor's protocol ID
- CDTEDDSNF2025
- Acronym
- DSNFMETSPH
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
PubMed 11742409International Diabetes Federation. The IDF consensus worldwide definition of the metabolic syndrome. Accessed November 7, 2024. https://idf.org/media/uploads/2023/05/attachments-30.pdf
Amihaesei IC, Chelaru L. Metabolic syndrome a widespread threatening condition; risk factors, diagnostic criteria, therapeutic options, prevention and controversies: an overview. Rev Med Chir Soc Med Nat Iasi. 2014 Oct-Dec;118(4):896-900.
PubMed 25581945Ranasinghe P, Mathangasinghe Y, Jayawardena R, Hills AP, Misra A. Prevalence and trends of metabolic syndrome among adults in the asia-pacific region: a systematic review. BMC Public Health. 2017 Jan 21;17(1):101. doi: 10.1186/s12889-017-4041-1.
PubMed 28109251
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06729008
- Acronym / sponsor ID
- DSNFMETSPH / CDTEDDSNF2025
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Diabetes-Specific Nutrition Formula, Philippines
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- St. Luke's Medical Center, PhilippinesUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Dec 2024 (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.
INTRODUCTION: Metabolic syndrome, a cluster of metabolic abnormalities, is a growing global health concern, particularly in the Asia-Pacific region. The Philippines has seen a significant rise in metabolic syndrome prevalence, linked to lifestyle factors and socioeconomic changes. This condition increases the risk of serious health issues like type 2 diabetes, cardiovascular disease, and mortality. Lifestyle modifications, including dietary interventions, are crucial for managing metabolic syndrome. While dietary recommendations exist, practical challenges hinder their implementation. Diabetes-specific nutrition formulas (DSNFs) offer a convenient and effective solution, especially for individuals with limited cooking skills or knowledge. While DSNFs show promise in managing diabetes, their impact on metabolic syndrome remains unclear. This study aims to investigate the effects of DSNF on the metabolic parameters of Filipino adults with metabolic syndrome.
METHODS: This open-label randomized crossover trial will be conducted at St. Luke's Medical Center Global City. Filipino adults aged 19-65 with metabolic syndrome will be recruited. Participants will be randomized to either a 90-day intervention phase (DSNF) with a 14-day washout period or a 90-day control phase. After the initial phase, participants will cross over to the alternate phase. The primary outcome will be the change in metabolic parameters in the metabolic syndrome criteria (fasting blood sugar, triglycerides, HDL cholesterol, blood pressure, and waist circumference). Secondary outcomes include changes in metabolic parameters related to the metabolic syndrome (glycosylated hemoglobin, total cholesterol, LDL cholesterol, body weight, BMI, body composition), and safety and tolerability of the treatments. Participants will be monitored through regular follow-up visits, daily food diaries, and subjective assessments. Data will be analyzed using appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSNF + MNT | Experimental | Dietary Supplement: Diabetes-specific nutrition formula (DSNF), Other: Medical Nutrition Therapy |
| MNT | Active comparator | Other: Medical Nutrition Therapy |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- An employee of St. Luke's Medical Center Global City for at least 1 year
- Of Filipino descent
- Aged 19-65 years
- Diagnosed with metabolic syndrome74 for at least 3 months, one of the criteria must include central obesity (WC of ≥90cm in Asian men, ≥80cm in Asian women)
- BMI of 23 kg/m2 or more
Key exclusion criteria (15 listed)
- Serious illness requiring medical attention within past year (active malignancy, HIV/AIDS, cardiovascular, respiratory, renal, or hepatic diseases)
- Use of medications affecting plasma glucose within 3 months (corticosteroids, diuretics, beta-blockers, antipsychotics, and HIV medications)
- Insulin use
- Severe hypoglycemia or hyperglycemia requiring hospitalization within past year
- Surgery or hospitalization within past 2-3 months
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 |
|---|---|---|
| Diabetes-specific nutrition formula (DSNF)The diabetes-specific nutrition formula to be used in this study will be Glucerna (Abbott Laboratories). It features an advanced blend of low-glycemic carbohydrates for steady energy release, a dual fiber blend to support digestive health, and a unique lipid blend free from trans fats, cholesterol, and low in saturated fat. Additionally, Glucerna is enriched with 4x more inositol and high levels of trivalent chromium, which contribute to maintaining normal blood glucose levels. It provides 28 essential vitamins and minerals, is low in lactose, and gluten-free, making it a suitable option for various dietary needs. 5 scoops will be mixed in 200 mL of water, and this amounts to 228 calories, with 30.01g of carbohydrates, 10.16g of protein, and 8.70g of fat. This will be given twice, as a breakfast replacement and an afternoon snack replacement. | Dietary supplement | DSNF + MNT |
| Medical Nutrition TherapyAlso: MNTMedical Nutrition Therapy is the standard of care for the management of metabolic syndrome | Other | DSNF + MNT, MNT |
Primary outcome
change from baseline to post-intervention in fasting blood sugar
Time frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: fasting blood sugar, measured in mg/dL.
change from baseline to post-intervention in HDL cholesterol
Time frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: HDL cholesterol, measured in mg/dL.
change from baseline to post-intervention in serum triglycerides
Time frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: serum triglycerides, measured in mg/dL.
change from baseline to post-intervention in systolic blood pressure
Time frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: systolic blood pressure, measured in mmHg.
change from baseline to post-intervention in diastolic blood pressure
Time frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: diastolic blood pressure, measured in mmHg.
change from baseline to post-intervention in waist circumference
Time frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: waist circumference, measured in centimeters.
9 secondary outcomes
change from baseline to post-intervention in glycosylated hemoglobin
Time frame: 3 months
change from baseline to post-intervention in LDL cholesterol
Time frame: 3 months
change from baseline to post-intervention in total cholesterol
Time frame: 3 months
change from baseline to post-intervention in body weight
Time frame: 3 months
change from baseline to post-intervention in body mass index
Time frame: 3 months
Adverse events related to the DSNF
Time frame: 3 months
Satiety scale
Time frame: 3 months
DSNF Compliance
Time frame: 3 months
Participants' perception of DSNF
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 11742409Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
- BackgroundInternational Diabetes Federation. The IDF consensus worldwide definition of the metabolic syndrome. Accessed November 7, 2024. https://idf.org/media/uploads/2023/05/attachments-30.pdf
- Background: PubMed 25581945Amihaesei IC, Chelaru L. Metabolic syndrome a widespread threatening condition; risk factors, diagnostic criteria, therapeutic options, prevention and controversies: an overview. Rev Med Chir Soc Med Nat Iasi. 2014 Oct-Dec;118(4):896-900.
- Background: PubMed 28109251Ranasinghe P, Mathangasinghe Y, Jayawardena R, Hills AP, Misra A. Prevalence and trends of metabolic syndrome among adults in the asia-pacific region: a systematic review. BMC Public Health. 2017 Jan 21;17(1):101. doi: 10.1186/s12889-017-4041-1.
- Individual participant dataSharing planned: Undecided
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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.
Joy Arabelle C Fontanilla, Doctor of Medicine principal investigator
St. Luke's Medical Center, Philippines
Maria Patricia Deanna D Maningat, Doctor of Medicine principal investigator
St. Luke's Medical Center, Philippines
Sahra May O Paragas, Doctor of Medicine principal investigator
St. Luke's Medical Center, Philippines
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes-specific nutrition formula (DSNF) and Medical Nutrition Therapy in people with Metabolic Syndrome, run by St. Luke's Medical Center, Philippines.
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 15 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: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelica Marie P Real, Doctor of Medicine (+639190979650, ampreal@stlukes.com.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline to post-intervention in fasting blood sugar (time frame: 3 months). The study lists 6 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 NCT06729008, which also lists 4 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 11 Dec 2024.