NCT05346978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

3.5 years

First QC Date

April 5, 2022

Last Update Submit

April 23, 2022

Conditions

Pre Diabetes

Keywords

Tropaeolum majus L.

Outcome Measures

Primary Outcomes (2)

  • Glucose response

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

    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).

    4 weeks

Secondary Outcomes (5)

  • IR-HOMA

    4 weeks

  • Insulin

    4 weeks

  • Castelli's risk index I and II

    4 weeks

  • Oxidized LDL

    4 weeks

  • Atherogenic Coefficient (AC)

    4 weeks

Study Arms (2)

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

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

Dietary Supplement: Placebo

Interventions

Nasturtium (Tropaeolum majus)DIETARY_SUPPLEMENT

Freeze dried nasturtium (Edible flower)

Nasturtium (NT)
PlaceboDIETARY_SUPPLEMENT

collagen colored with green pigment used in the food industry

Placebo (PLC)

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Cundinamarca, Colombia

Location

Related Publications (7)

  • 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.

    PMID: 22325157BACKGROUND

  • 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.

    PMID: 22537070BACKGROUND

  • 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.

    PMID: 20724400BACKGROUND

  • 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.

    PMID: 22578879BACKGROUND

  • 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.

    PMID: 35010932BACKGROUND

  • 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.

    PMID: 34964876BACKGROUND

  • 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.

    PMID: 26610401BACKGROUND

Related Links

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Valentina Guzman, PhD

    Pontificia Universidad Javeriana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 26, 2022

Study Start

June 1, 2018

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)