Pre DiabetesNCT05346978
Nasturtium (Tropaeolum Majus L) Intake and Biochemical Parameters in Pre-diabetic Subjects in Bogota Colombia
A study testing Nasturtium (Tropaeolum majus) in people with Pre Diabetes, run by Javeriana University at 1 site in Colombia.
Trial summary
Brassicaceae plant family have a high content of bioactive compounds such as e.g. glucosinolates (GSLs) and isothiocyanates (ICTs) associated, recently, with diabetes prevention. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Nasturtium (Tropaeolum majus)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2018to 15 Nov 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 25-60 years, with a clinical diagnosis of glucose intolerance for at least six months.
- Body mass index (BMI) > 30 kg/m2. The BMI will be restricted to > 30 kg/m2 to reduce the variability in the lipid profile parameters, which frequently are normal in subject with normal BMI.
- Sign informed consent
Who cannot join
- Severe impairment of cardiac, hepatic or renal function.
- Gestation or lactation
- Use of insulin injection
- Pharmacotherapy with metformin or iDPP4, which alter insulin sensitivity or Glycaemia
- Consumption of antioxidant or vitamin supplements
- Consumption of estrogen or vitamin K-antagonists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Consumption of a Lyophilized Nasturtium (Tropaeolum Majus L), on the Insulin Response, Lipid Profile, Antioxidant Capacity and Gene Expression in Pre-diabetic Subjects: Bogotá-Colombia
Brassicaceae plant family have a high content of bioactive compounds such as e.g. glucosinolates (GSLs) and isothiocyanates (ICTs) associated, recently, with diabetes prevention. This research proposal has the intention of evaluating if the ingestion of freeze-dried nasturtium has a positive effect on the insulin response, lipid profile, oxidative stress biomarkers and gene expression of RESISTIN, GLUT 4, acetyl-CoA carboxylase-a (ACC), fatty acid synthase (FASN), NRF-2, NQO1, SFRXN1, glutathione peroxidase 2 (GPx-2), FOXO1, FOXO3 and FOXO6 in subjects with glucose intolerance.
Read the detailed description
Epidemiological and animal studies have shown that consumption of fruits and vegetables decreases the risk of chronic diseases. Especially in T2D, the primary prevention is considered as a public health priority. Some studies show an inverse association between vegetables intake and T2D prevention, although the underlying mechanisms and the effect of individual antioxidant compounds are still unclear.
Brassicaceae plant family (e.g., broccoli, cabbage, brussels sprouts, watercress, Nasturtium, garden cress, kale, cauliflower), have a high content of bioactive compounds such as e.g. glucosinolates (GSLs), isothiocyanates (ICTs) and polyphenols, associated, recently, with diabetes prevention (18). Human studies in diabetic patients have shown that the consumption of broccoli sprouts powder (BSP) containing high concentration of the GLS sulphoraphane for 4 weeks decreases serum insulin concentration, homoeostasis model assessment of insulin resistance (HOMA-IR), LDL, inflammation and antioxidant markers. Besides sulphoraphane other GLSs have showed a protective effect in diabetes. Recently, mice fed with very high fat diet (VHFD) supplemented with 5% of moringa concentrate rich in benzyl isothiocyanate showed that moringa isothiocyanates (MICs) improved glucose tolerance and insulin signaling; reduced plasma leptin, resistin, cholesterol, IL-1β, TNFα, and lower hepatic glucose-6-phosphatase (G6Pase) gene expression. This evidence suggest that MICs could play a role in T2D prevention probably by inhibiting rate-limiting steps in liver gluconeogenesis resulting in direct or indirect increase in insulin signaling and sensitivity.
Recently in vitro studies in human and osteosarcoma hepatoma cells (HepG2 cells) stimulated with benzyl isothiocyanate (BITC) from Tropaeolum majus, show that this compound is able of 1) regulate the insulin signaling pathway, 2) down-regulate the gene and protein expression of gluconeogenic enzymes G6Pase and phosphoenol piruvatokinase (PEPCK) and 3) up-regulate the gene expression of antioxidant and phase II detoxification genes manganese superoxide dismutase (MnSOD), nuclear factor (erythroid derived)-like2 (NRF2), NAD(P)H dehydrogenase (quinone 1) (NQO1) and sulfiredoxin-1 (SFRXN1) (21). According with this evidence BITC could mimics the fasting state, in which insulin stimuli is absent and transcription factors remain in the nucleus modulating gene expression of their target genes, with the advantage of down-regulating gluconeogenesis instead of increase it suggesting that BITC could have a therapeutic role in the prevention or treatment of T2D.
Despite of strong evidence of 1) chronic inflammation as an underlying cause of T2D, and 2) high levels of oxidative stress under T2D conditions the use of ITC-rich foods as therapeutics in T2D remains virtually unknown. For that reason this research proposal has the intention of evaluating if the ingestion of freeze-dried nasturtium has a positive effect on the insulin response, lipid profile, oxidative stress biomarkers and gene expression of RESISTIN, GLUT 4, acetyl-CoA carboxylase-a (ACC), fatty acid synthase (FASN), NRF-2, NQO1, SFRXN1, glutathione peroxidase 2 (GPx-2), FOXO1, FOXO3 and FOXO6 in subjects with glucose intolerance.
- Conditions
- Pre Diabetes
- Being tested
- Nasturtium (Tropaeolum majus), Placebo
- Keywords
- Tropaeolum majus L.
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasturtium (Tropaeolum majus)Dietary supplement
Freeze dried nasturtium (Edible flower)
PlaceboDietary supplement
collagen colored with green pigment used in the food industry
| Study group | Role | What they receive |
|---|---|---|
| Nasturtium (NT) | Experimental | 5g freeze-dried nasturtium leaf powder ; Each participant was supplemented with 15 grams of freeze-dried nasturtium leaf powder (NT) or placebo (PLC) per wk during 4 wk. Each participant received 3 envelopes per wk with 5 g NT each or 3 g PLC. In total each participant was given 24 envelopes (12 NT and 12 PLC) packaged in the same way to be indistinguishable from each other. The participants were instructed to take three days at wk one NT or PLC envelope diluted in 300 ml (about 10.14 oz) in chilly water in a bottle provided for the study Receives: Dietary Supplement: Nasturtium (Tropaeolum majus) |
| Placebo (PLC) | Placebo comparator | 3g collagen colored with green pigment used in the food industry; Each participant was supplemented with 15 grams of freeze-dried nasturtium leaf powder (NT) or placebo (PLC) per wk during 4 wk. Each participant received 3 envelopes per wk with 5 g NT each or 3 g PLC. In total each participant was given 24 envelopes (12 NT and 12 PLC) packaged in the same way to be indistinguishable from each other. The participants were instructed to take three days at wk one NT or PLC envelope diluted in 300 ml (about 10.14 oz) in chilly water in a bottle provided for the study Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response
Fasting and postprandial blood glucose (mmol/L) was measured by the enzymatic colorimetric method (Beckman Coulter, CA, USA)
Measured: 4 weeks
Lipid profile
total cholesterol (mmol/L), triglycerides level (mmol/L), High density lipoprotein cholesterol (mmol/L) and Low density lipoprotein cholesterol (mmol/L) were measured by enzymatic colorimetric analysis (Beckman Coulter, CA, USA).
Measured: 4 weeks
Secondary outcomes (5)
IR-HOMA
Homeostatic model assessment for Insulin Resistance was calculated with the formula (Basal Insulin (μU/L) x fasting blood glucose (mmol/L)/22.5)
Measured: 4 weeks
Insulin
Insulin (uU/mL) was measured by chemiluminescent microparticle immunoassay (CMIA) (Abbott, IL, USA).
Measured: 4 weeks
Castelli's risk index I and II
CT/HDL-c and LDL-c/HDL-c were calculated as cardiovascular risk factors parameters, at baseline and 4 weeks after treatment.
Measured: 4 weeks
Oxidized LDL
OX-LDL (pg/mL). For quantify the concentration of serum oxidized LDL used ELISA kit (Novus Biologicals, USA)
Measured: 4 weeks
Atherogenic Coefficient (AC)
non- HDLc)/ HDL-c were calculated as cardiovascular risk factors parameters, at baseline and 4 weeks after treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jun 2018
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javeriana University
- Sponsor type
- University, hospital or other
- Collaborators
- Leibniz Institute of Vegetable and Ornamental Crops (IGZ), University Medical Center Freiburg
- Responsible party
- Principal investigator, Valentina Guzman, Javeriana University
- Investigators
- Valentina Guzman, PhD, Principal investigator, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346978
- Sponsor's protocol ID
- 7147
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bahadoran Z, Mirmiran P, Hosseinpanah F, Rajab A, Asghari G, Azizi F. Broccoli sprouts powder could improve serum triglyceride and oxidized LDL/LDL-cholesterol ratio in type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial. Diabetes Res Clin Pract. 2012 Jun;96(3):348-54. doi: 10.1016/j.diabres.2012.01.009. Epub 2012 Feb 9.
PubMed 22325157Bahadoran Z, Tohidi M, Nazeri P, Mehran M, Azizi F, Mirmiran P. Effect of broccoli sprouts on insulin resistance in type 2 diabetic patients: a randomized double-blind clinical trial. Int J Food Sci Nutr. 2012 Nov;63(7):767-71. doi: 10.3109/09637486.2012.665043. Epub 2012 Apr 26.
PubMed 22537070Carter P, Gray LJ, Troughton J, Khunti K, Davies MJ. Fruit and vegetable intake and incidence of type 2 diabetes mellitus: systematic review and meta-analysis. BMJ. 2010 Aug 18;341:c4229. doi: 10.1136/bmj.c4229.
PubMed 20724400Dinkova-Kostova AT, Kostov RV. Glucosinolates and isothiocyanates in health and disease. Trends Mol Med. 2012 Jun;18(6):337-47. doi: 10.1016/j.molmed.2012.04.003. Epub 2012 May 10.
PubMed 22578879Gomez-Martinez S, Diaz-Prieto LE, Vicente Castro I, Jurado C, Iturmendi N, Martin-Ridaura MC, Calle N, Duenas M, Picon MJ, Marcos A, Nova E. Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes. Nutrients. 2021 Dec 24;14(1):57. doi: 10.3390/nu14010057.
PubMed 35010932American Diabetes Association Professional Practice Committee. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S39-S45. doi: 10.2337/dc22-S003.
PubMed 34964876Platz S, Kuhn C, Schiess S, Schreiner M, Kemper M, Pivovarova O, Pfeiffer AF, Rohn S. Bioavailability and metabolism of benzyl glucosinolate in humans consuming Indian cress (Tropaeolum majus L.). Mol Nutr Food Res. 2016 Mar;60(3):652-60. doi: 10.1002/mnfr.201500633. Epub 2015 Dec 28.
PubMed 26610401
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of a Lyophilized Nasturtium (Tropaeolum Majus L), on the Insulin Response, Lipid Profile, Antioxidant Capacity and Gene Expression in Pre-diabetic Subjects: Bogotá-Colombia
- ClinicalTrials.gov ID
- NCT05346978
- Acronym / sponsor ID
- 7147
- Conditions
- Pre Diabetes
- Keywords
- Tropaeolum majus L.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Javeriana UniversityUniversity, hospital or other
- Collaborators
- Leibniz Institute of Vegetable and Ornamental Crops (IGZ), University Medical Center Freiburg
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brassicaceae plant family have a high content of bioactive compounds such as e.g. glucosinolates (GSLs) and isothiocyanates (ICTs) associated, recently, with diabetes prevention. This research proposal has the intention of evaluating if the ingestion of freeze-dried nasturtium has a positive effect on the insulin response, lipid profile, oxidative stress biomarkers and gene expression of RESISTIN, GLUT 4, acetyl-CoA carboxylase-a (ACC), fatty acid synthase (FASN), NRF-2, NQO1, SFRXN1, glutathione peroxidase 2 (GPx-2), FOXO1, FOXO3 and FOXO6 in subjects with glucose intolerance.
Detailed description
Epidemiological and animal studies have shown that consumption of fruits and vegetables decreases the risk of chronic diseases. Especially in T2D, the primary prevention is considered as a public health priority. Some studies show an inverse association between vegetables intake and T2D prevention, although the underlying mechanisms and the effect of individual antioxidant compounds are still unclear.
Brassicaceae plant family (e.g., broccoli, cabbage, brussels sprouts, watercress, Nasturtium, garden cress, kale, cauliflower), have a high content of bioactive compounds such as e.g. glucosinolates (GSLs), isothiocyanates (ICTs) and polyphenols, associated, recently, with diabetes prevention (18). Human studies in diabetic patients have shown that the consumption of broccoli sprouts powder (BSP) containing high concentration of the GLS sulphoraphane for 4 weeks decreases serum insulin concentration, homoeostasis model assessment of insulin resistance (HOMA-IR), LDL, inflammation and antioxidant markers. Besides sulphoraphane other GLSs have showed a protective effect in diabetes. Recently, mice fed with very high fat diet (VHFD) supplemented with 5% of moringa concentrate rich in benzyl isothiocyanate showed that moringa isothiocyanates (MICs) improved glucose tolerance and insulin signaling; reduced plasma leptin, resistin, cholesterol, IL-1β, TNFα, and lower hepatic glucose-6-phosphatase (G6Pase) gene expression. This evidence suggest that MICs could play a role in T2D prevention probably by inhibiting rate-limiting steps in liver gluconeogenesis resulting in direct or indirect increase in insulin signaling and sensitivity.
Recently in vitro studies in human and osteosarcoma hepatoma cells (HepG2 cells) stimulated with benzyl isothiocyanate (BITC) from Tropaeolum majus, show that this compound is able of 1) regulate the insulin signaling pathway, 2) down-regulate the gene and protein expression of gluconeogenic enzymes G6Pase and phosphoenol piruvatokinase (PEPCK) and 3) up-regulate the gene expression of antioxidant and phase II detoxification genes manganese superoxide dismutase (MnSOD), nuclear factor (erythroid derived)-like2 (NRF2), NAD(P)H dehydrogenase (quinone 1) (NQO1) and sulfiredoxin-1 (SFRXN1) (21). According with this evidence BITC could mimics the fasting state, in which insulin stimuli is absent and transcription factors remain in the nucleus modulating gene expression of their target genes, with the advantage of down-regulating gluconeogenesis instead of increase it suggesting that BITC could have a therapeutic role in the prevention or treatment of T2D.
Despite of strong evidence of 1) chronic inflammation as an underlying cause of T2D, and 2) high levels of oxidative stress under T2D conditions the use of ITC-rich foods as therapeutics in T2D remains virtually unknown. For that reason this research proposal has the intention of evaluating if the ingestion of freeze-dried nasturtium has a positive effect on the insulin response, lipid profile, oxidative stress biomarkers and gene expression of RESISTIN, GLUT 4, acetyl-CoA carboxylase-a (ACC), fatty acid synthase (FASN), NRF-2, NQO1, SFRXN1, glutathione peroxidase 2 (GPx-2), FOXO1, FOXO3 and FOXO6 in subjects with glucose intolerance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasturtium (NT) | Experimental | Dietary Supplement: Nasturtium (Tropaeolum majus)5g freeze-dried nasturtium leaf powder ; Each participant was supplemented with 15 grams of freeze-dried nasturtium leaf powder (NT) or placebo (PLC) per wk during 4 wk. Each participant received 3 envelopes per wk with 5 g NT each or 3 g PLC. In total each participant was given 24 envelopes (12 NT and 12 PLC) packaged in the same way to be indistinguishable from each other. The participants were instructed to take three days at wk one NT or PLC envelope diluted in 300 ml (about 10.14 oz) in chilly water in a bottle provided for the study |
| Placebo (PLC) | Placebo comparator | Dietary Supplement: Placebo3g collagen colored with green pigment used in the food industry; Each participant was supplemented with 15 grams of freeze-dried nasturtium leaf powder (NT) or placebo (PLC) per wk during 4 wk. Each participant received 3 envelopes per wk with 5 g NT each or 3 g PLC. In total each participant was given 24 envelopes (12 NT and 12 PLC) packaged in the same way to be indistinguishable from each other. The participants were instructed to take three days at wk one NT or PLC envelope diluted in 300 ml (about 10.14 oz) in chilly water in a bottle provided for the study |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 25-60 years, with a clinical diagnosis of glucose intolerance for at least six months.
- Body mass index (BMI) > 30 kg/m2. The BMI will be restricted to > 30 kg/m2 to reduce the variability in the lipid profile parameters, which frequently are normal in subject with normal BMI.
- Sign informed consent
Key exclusion criteria (6 listed)
- Severe impairment of cardiac, hepatic or renal function.
- Gestation or lactation
- Use of insulin injection
- Pharmacotherapy with metformin or iDPP4, which alter insulin sensitivity or Glycaemia
- Consumption of antioxidant or vitamin supplements
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 |
|---|---|---|
| Nasturtium (Tropaeolum majus)Freeze dried nasturtium (Edible flower) | Dietary supplement | Nasturtium (NT) |
| Placebocollagen colored with green pigment used in the food industry | Dietary supplement | Placebo (PLC) |
Primary outcome
Glucose response
Time frame: 4 weeks
Fasting and postprandial blood glucose (mmol/L) was measured by the enzymatic colorimetric method (Beckman Coulter, CA, USA)
Lipid profile
Time frame: 4 weeks
total cholesterol (mmol/L), triglycerides level (mmol/L), High density lipoprotein cholesterol (mmol/L) and Low density lipoprotein cholesterol (mmol/L) were measured by enzymatic colorimetric analysis (Beckman Coulter, CA, USA).
5 secondary outcomes
IR-HOMA
Time frame: 4 weeks
Insulin
Time frame: 4 weeks
Castelli's risk index I and II
Time frame: 4 weeks
Oxidized LDL
Time frame: 4 weeks
Atherogenic Coefficient (AC)
Time frame: 4 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 26 Apr 2022.
- Background: PubMed 22325157Bahadoran Z, Mirmiran P, Hosseinpanah F, Rajab A, Asghari G, Azizi F. Broccoli sprouts powder could improve serum triglyceride and oxidized LDL/LDL-cholesterol ratio in type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial. Diabetes Res Clin Pract. 2012 Jun;96(3):348-54. doi: 10.1016/j.diabres.2012.01.009. Epub 2012 Feb 9.
- Background: PubMed 22537070Bahadoran Z, Tohidi M, Nazeri P, Mehran M, Azizi F, Mirmiran P. Effect of broccoli sprouts on insulin resistance in type 2 diabetic patients: a randomized double-blind clinical trial. Int J Food Sci Nutr. 2012 Nov;63(7):767-71. doi: 10.3109/09637486.2012.665043. Epub 2012 Apr 26.
- Background: PubMed 20724400Carter P, Gray LJ, Troughton J, Khunti K, Davies MJ. Fruit and vegetable intake and incidence of type 2 diabetes mellitus: systematic review and meta-analysis. BMJ. 2010 Aug 18;341:c4229. doi: 10.1136/bmj.c4229.
- Background: PubMed 22578879Dinkova-Kostova AT, Kostov RV. Glucosinolates and isothiocyanates in health and disease. Trends Mol Med. 2012 Jun;18(6):337-47. doi: 10.1016/j.molmed.2012.04.003. Epub 2012 May 10.
- Background: PubMed 35010932Gomez-Martinez S, Diaz-Prieto LE, Vicente Castro I, Jurado C, Iturmendi N, Martin-Ridaura MC, Calle N, Duenas M, Picon MJ, Marcos A, Nova E. Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes. Nutrients. 2021 Dec 24;14(1):57. doi: 10.3390/nu14010057.
- Background: PubMed 34964876American Diabetes Association Professional Practice Committee. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S39-S45. doi: 10.2337/dc22-S003.
- Background: PubMed 26610401Platz S, Kuhn C, Schiess S, Schreiner M, Kemper M, Pivovarova O, Pfeiffer AF, Rohn S. Bioavailability and metabolism of benzyl glucosinolate in humans consuming Indian cress (Tropaeolum majus L.). Mol Nutr Food Res. 2016 Mar;60(3):652-60. doi: 10.1002/mnfr.201500633. Epub 2015 Dec 28.
- Nasturtium (Tropaeolum majus L.) contains high concentrations of benzylglcosinolate. We found that a hydrolysis product of benzyl glucosinolate-the benzyl isothiocyanate (BITC)-modulates the intracellular localization of the transcription factor ForkheadLink provided by the sponsor.
- 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.
Valentina Guzman, PhD principal investigator
Pontificia Universidad Javeriana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasturtium (Tropaeolum majus) in people with Pre Diabetes, run by Javeriana University at 1 site in Colombia.
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 3 inclusion and 6 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 26 Apr 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 Colombia. 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?
Glucose response (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346978, which also lists 7 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 26 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.