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Nasturtium (Tropaeolum Majus L) Intake and Biochemical Parameters in Pre-diabetic Subjects in Bogota Colombia

Primary Purpose

Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Nasturtium (Tropaeolum majus)
Placebo
Sponsored by
Javeriana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes focused on measuring Tropaeolum majus L.

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital Universitario San Ignacio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nasturtium (NT)

Placebo (PLC)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glucose response
Fasting and postprandial blood glucose (mmol/L) was measured by the enzymatic colorimetric method (Beckman Coulter, CA, USA)
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).

Secondary Outcome Measures

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)
Insulin
Insulin (uU/mL) was measured by chemiluminescent microparticle immunoassay (CMIA) (Abbott, IL, USA).
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.
Oxidized LDL
OX-LDL (pg/mL). For quantify the concentration of serum oxidized LDL used ELISA kit (Novus Biologicals, USA)
Atherogenic Coefficient (AC)
non- HDLc)/ HDL-c were calculated as cardiovascular risk factors parameters, at baseline and 4 weeks after treatment.

Full Information

First Posted
April 5, 2022
Last Updated
April 23, 2022
Sponsor
Javeriana University
Collaborators
Leibniz Institute of Vegetable and Ornamental Crops (IGZ), University Medical Center Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT05346978
Brief Title
Nasturtium (Tropaeolum Majus L) Intake and Biochemical Parameters in Pre-diabetic Subjects in Bogota Colombia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Javeriana University
Collaborators
Leibniz Institute of Vegetable and Ornamental Crops (IGZ), University Medical Center Freiburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes
Keywords
Tropaeolum majus L.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasturtium (NT)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo (PLC)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Nasturtium (Tropaeolum majus)
Intervention Description
Freeze dried nasturtium (Edible flower)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
collagen colored with green pigment used in the food industry
Primary Outcome Measure Information:
Title
Glucose response
Description
Fasting and postprandial blood glucose (mmol/L) was measured by the enzymatic colorimetric method (Beckman Coulter, CA, USA)
Time Frame
4 weeks
Title
Lipid profile
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
IR-HOMA
Description
Homeostatic model assessment for Insulin Resistance was calculated with the formula (Basal Insulin (μU/L) x fasting blood glucose (mmol/L)/22.5)
Time Frame
4 weeks
Title
Insulin
Description
Insulin (uU/mL) was measured by chemiluminescent microparticle immunoassay (CMIA) (Abbott, IL, USA).
Time Frame
4 weeks
Title
Castelli's risk index I and II
Description
CT/HDL-c and LDL-c/HDL-c were calculated as cardiovascular risk factors parameters, at baseline and 4 weeks after treatment.
Time Frame
4 weeks
Title
Oxidized LDL
Description
OX-LDL (pg/mL). For quantify the concentration of serum oxidized LDL used ELISA kit (Novus Biologicals, USA)
Time Frame
4 weeks
Title
Atherogenic Coefficient (AC)
Description
non- HDLc)/ HDL-c were calculated as cardiovascular risk factors parameters, at baseline and 4 weeks after treatment.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Guzman, PhD
Organizational Affiliation
Pontificia Universidad Javeriana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario San Ignacio
City
Bogotá
State/Province
Cundinamarca
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22325157
Citation
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.
Results Reference
background
PubMed Identifier
22537070
Citation
Bahadoran 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.
Results Reference
background
PubMed Identifier
20724400
Citation
Carter 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.
Results Reference
background
PubMed Identifier
22578879
Citation
Dinkova-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.
Results Reference
background
PubMed Identifier
35010932
Citation
Gomez-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.
Results Reference
background
PubMed Identifier
34964876
Citation
American 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.
Results Reference
background
PubMed Identifier
26610401
Citation
Platz 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.
Results Reference
background
Links:
URL
http://doi.org/10.1371/journal.pone.0162397
Description
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 Forkhead

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Nasturtium (Tropaeolum Majus L) Intake and Biochemical Parameters in Pre-diabetic Subjects in Bogota Colombia

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