The beneficial effect on sugar metabolism of a food supplement based on plant extracts, zinc and chromium
| ISRCTN | ISRCTN15697400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15697400 |
| Secondary identifying numbers | GLIKUR_01 |
- Submission date
- 24/01/2024
- Registration date
- 16/02/2024
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Metabolic Syndrome (MetS) is a multifactorial disease given the diverse range of risk factors involved and the numerous complications that can develop over time, affecting various bodily systems. Lifestyle modifications, especially dietary habits can significantly reduce MetS prevalence. When lifestyle changes and a healthy diet are insufficient to manage risk factors associated with MetS, medications become essential for controlling blood pressure, improving insulin sensitivity, and reducing cholesterol and triglyceride levels. In cases where lifestyle modifications are ineffective but before resorting to medication, the use of food supplements could be a safe and effective strategy for mitigating MetS risk factors. In recent years, researchers have been looking into a new extract from a type of Italian purple corn (Zea mays L.) known as Moradyn. This extract, rich in polyphenols, shows promise in inhibiting digestive enzymes that break down carbohydrates and preventing the formation of AGEs (advanced glycation end-products) – substances associated with aging. Additionally, leaves from the Gymnema sylvestre plant have been studied for their potential to control blood sugar levels. These leaves contain various beneficial compounds, including gymnemic acid, guaranine peptide, stigmasterol, quercetol, betaine, choline, and trimethylamine. There is also a connection between mineral deficiency, particularly in zinc and chromium, and disruptions in glucose and insulin regulation. Zinc is crucial for insulin synthesis and secretion, as well as for pathways that regulate insulin's actions. A zinc deficiency is linked to risk factors for diabetes and cardiovascular diseases. Chromium, another essential element, acts as a cofactor for insulin. Inadequate chromium intake may lead to increased insulin secretion, resulting in issues like hyperinsulinemia, insulin resistance, and weight gain. This clinical trial aims to demonstrate that the food supplement consisting of Zea mays L. and Gymenema sylvestre (Retz.) R.br. ex Sm extracts, zinc, and chromium play a positive role in maintaining the normal metabolism of carbohydrates and lipids, bringing benefits to the subjects who take this food supplement.
Who can participate?
Patients aged 18-77 years old who present impaired fasting blood glucose
What does the study involve?
Participants will consume a food supplement based on Moradyn® (purple corn variety extract Zea mays L. fruit), Gymnema sylvestre (Retz.) R.Br. ex Sm. leaves, zinc and chromium, at two different doses, or a placebo, for 90 days, based on the randomization group.
What are the possible benefits and risks of participating?
An improvement in the clinical cardiovascular health of participants in the two food supplement groups is hypothesized. However, no benefit may be achieved. No risks are foreseen.
Where is the study run from?
National Inter-university Consortium of Research in Innovative Pharmaceutical Technologies - Tefarco Innova (Italy)
When is the study starting and how long is it expected to run for?
February 2021 to December 2021
Who is funding the study?
National Inter-university Consortium of Research in Innovative Pharmaceutical Technologies - Tefarco Innova (Italy)
Who is the main contact?
1. Prof. Maria Daglia (scientific) maria.daglia@unina.it
2. Dr. Alessandra Baldi (public) alessandra.baldi.alimenti@gmail.com
Contact information
Public
Parco Area delle Scienze, 27/A
Parma
43124
Italy
 ORCID ID |
0000-0002-2877-9445 |
|---|---|
| Phone | +39 0521 905073 |
| alessandra.baldi.alimenti@gmail.com |
Scientific
Via Domenico Montesano, 49
Napoli
80131
Italy
| ORCID ID |
0000-0002-2877-9445 |
|---|---|
| Phone | 081 678102 |
| maria.daglia@unina.it |
Principal Investigator
Via Tommaso Picazio, 26
Caserta
81100
Italy
| Phone | 082424244 |
|---|---|
| agostino.greco@alice.it |
Study information
| Study design | Interventional monocentric randomized parallel three-arm double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Efficacy study of the food supplement based on Moradyn® (purple corn variety extract Zea mays L.), Gymnema, Zinc, and Chromium, commercial name “GLIKUR Advance” for the maintenance of normal carbohydrate metabolism through the reduction of slightly altered plasma glucose levels, as cardiovascular risk factors: single-center, controlled, randomized, parallel-group, double-blind clinical study. |
| Study acronym | GLIKUR |
| Study hypothesis | This study aims to evaluate the efficacy of the supplementation of the diet with a food supplement based on Moradyn® (purple corn variety extract Zea mays L. fruit), Gymnema sylvestre (Retz.) R.Br. ex Sm. leaves, zinc and chromium, in the maintenance of normal carbohydrate metabolism through the reduction of plasma glucose levels in patients with impaired fasting plasma glucose (fasting plasma glucose between 90 and 120 mg/dL), which numerous clinical studies define as an important cardiovascular risk factor. |
| Ethics approval(s) |
Approved 18/04/2021, Ethics Committee of North Campania (Contrada Amoretta - Città Ospedaliera, Avellino, 83100, Italy; +39 (0)825/203025; comitatoeticoav@gmail.com), ref: 817 |
| Condition | Impaired fasting plasma glucose (fasting plasma glucose between 90 and 120 mg/dL) |
| Intervention | The subjects recruited in the present clinical study will consume a food supplement based on Moradyn® (purple corn variety extract Zea mays L. fruit), Gymnema sylvestre (Retz.) R.Br. ex Sm. leaves, zinc and chromium, at two doses (1560 mg/day – 2 tabs, or 780 mg/day - 1 tab), or a placebo, for 90 days, based on the randomization group. In particular, to maintain the double-blind design, Group 1 will be treated with two tablets of Glikur Advance (based on Moradyn®, Gymnema, Zinc and Chromium) daily for 3-months, Group 2 will be treated with one tablet of the dietary supplement and one tablet of cellulose (placebo) daily for 3-months, while Group 3 consisted of subjects who have taken two tablets of placebo, according to the parallel group design. The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list will be kept hidden. The participants will be assigned to each of the two treatment groups (food supplement or placebo) casually and by simple randomization (1:1:1 allocation ratio). The randomization code will consist of a three-digit number as indicated in the respective Case Report Form (CRF). In the clinical study, 81 participants will be enrolled and divided into three groups (27 for each group): - Group 1: two tablets of the dietary supplement Glikur Advance* (based on Moradyn®, Gymnema, Zinc and Chromium) daily for 3-months - Group 2: one tablet of the dietary supplement Glikur Advance* and one tablet of cellulose (placebo) daily for 3-months - Group 3: two tablets of placebo daily for 3-months Participants will undergo three visits (baseline = t0; after 30 days of treatment = t1; after 90 days of treatment = t2) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. The clinical trial design is reported below: During the screening visit, subjects will undergo the study participation requirements confirmation: - Impaired fasting glycemia (IFG) between 98 and 125 mg/dl. Subsequently, all enrolled subjects will undergo the following: - at t0, and t2 (at baseline, and 90 days from the start of treatment) the recruited subjects were submitted to blood sampling for the evaluation of the following biochemical parameters: fasting glucose levels, HbA1c, insulin, HOMA Index, total cholesterol (TC), Low-Density Lipoproteins (LDL-C) cholesterol, High-Density Lipoprotein (HDL-C) cholesterol, Triglycerides (TG), SGOT and SGPT (hepatic toxicity), Creatinine (renal toxicity). |
| Intervention type | Supplement |
| Primary outcome measure | Improvement in fasting plasma glucose levels measured using blood tests for fasting serum glucose levels, HbA1c, fasting serum insulin levels and HOMA Index at baseline (t0), 90 days of treatment (t2) |
| Secondary outcome measures | 1. Beneficial effect on lipid metabolism measured using the determination of blood levels of total cholesterol (TC), Low-Density Lipoproteins (LDL-C) cholesterol, High-Density Lipoprotein (HDL-C) cholesterol, Triglycerides (TG) at baseline (t0), 90 days of treatment (t2) 2. Height/weight assessment to calculate BMI at baseline (t0), 90 days of treatment (t2) 3. Liver and kidney toxicity measured using blood tests for the biomarkers aspartate transaminase (AST or SGOT), alanine transaminase (ALT or SGPT), and creatinine at baseline (t0), 30 days of treatment (t1), 90 days of treatment (t2). |
| Overall study start date | 13/02/2021 |
| Overall study end date | 13/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 81 |
| Total final enrolment | 81 |
| Participant inclusion criteria | 1. Aged 18-75 years old of both sexes 2. Able to understand and sign the informed consent 3. 98 mg/dL < impaired fasting glycemia < 125 mg/dL |
| Participant exclusion criteria | 1. Aged < 18 and > 75 years old 2. A medical history or condition that could affect the subject's safety or negatively impact the validity of the study results 3. Pregnant or breastfeeding women 4. With a history of allergy to ingredients contained in the study treatments (dietary supplement and placebo) 5. Exposed to a high risk of cardiovascular events based on 8 risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterolemia, hdl-cholesterolemia and antihypertensive treatment) 6. Following drug therapy for diabetes even at low dosages 7. Taking supplements to control cholesterol, blood sugar and metabolic syndrome, in the two weeks prior to recruitment 8. Women who suspect pregnant or planning pregnancy 9. Blood donors in the three months prior to recruitment 10. Non-self-sufficient individuals 11. Who does not show a propensity to collaborate 12. Who have difficulty getting to the reference facility within the scheduled time 13. Who are not considered suitable by the investigators due to the presence of other pathologies considered incompatible with enrollment. |
| Recruitment start date | 13/05/2021 |
| Recruitment end date | 10/06/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Caserta
81100
Italy
Sponsor information
Research organisation
Parco Area delle Scienze, 27/A
Parma
43124
Italy
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication. |
Editorial Notes
06/03/2024: The intention to publish date was changed from 28/02/2024 to 30/06/2024.
29/01/2024: Study's existence confirmed by the Ethics Committee of North Campania.
