Effect of resveratrol on cognitive functions and inflammation in a population of older adults with type 2 diabetes mellitus

ISRCTN	ISRCTN15172592
DOI	https://doi.org/10.1186/ISRCTN15172592
Secondary identifying numbers	IN308120

Submission date: 24/07/2021
Registration date: 27/09/2021
Last edited: 09/10/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Currently, people live longer and this has caused an increase in the presence of diseases such as high blood pressure, obesity and type 2 diabetes mellitus (DM2), among others.
Oxidative stress (an imbalance between free radicals and antioxidants in your body) is thought to play a role in complications of diabetes.
Resveratrol (RV) is part of a group of compounds called polyphenols. They’re thought to act like antioxidants, protecting the body against damage that can put you at higher risk for things like cancer and heart disease. It’s in the skin of red grapes, but you can also find it in peanuts and berries.
The main objective of this project is to know how resveratrol works on markers of oxidative stress, chronic inflammation and cognitive functions in a group of elderly patients with DM2.

Who can participate?
Adults over 60 years of age, residents of Mexico City, diagnosed with DM2, without intake of alcohol, tobacco, or antioxidant supplements or hormone replacement in the case of women.

What does the study involve?
Participants are randomly divided into three groups: i) Experimental A (500 mg of RV), ii) Experimental B (1000 mg of RV) and iii) Placebo. Oxidative stress markers, chronic inflammatory response and cognitive functions will be measured in each subject pre and post-intervention at 6 and 12 months.

What are the possible benefits and risks of participating?
The tests carried out and the RV will have no cost. The information collected will be strictly confidential. The results of glucose, lipid profile, kidney profile, hematic biometry and glycated hemoglobin will be delivered to the patients for the control and monitoring of their health status.
There is no health risk, RV has been shown to be safe and approved for use in humans. The taking of blood samples will be carried out by qualified personnel, with new and disposable material.

Where is this study run from?
National Autonomous University of Mexico (Mexico)

When is the study starting and how long is it expected to run for?
May 2020 to October 2022

Who is funding this study?
National Autonomous University of Mexico

Who is the main contact?
Dr Mirna Ruiz-Ramos, mirna1411@yahoo.com.mx

Study website

Contact information

Dr Mirna Ruiz-Ramos
Scientific

Guelatao 66 Colonia Ejercito de Oriente Delegación Iztapalapa
Mexico City
09230
Mexico

ORCID ID	0000-0001-9971-3905
Phone	+52 (0)5556230700 Etx. 39182
Email	mirnar@comunidad.unam.mx

Dr Víctor Manuel Mendoza-Núñez
Scientific

Guelatao 66 Colonia Ejercito de Oriente Delegación Iztapalapa
Mexico City
09230
Mexico

ORCID ID	0000-0002-9137-3405
Phone	+52 (0)5556230700 Ext. 39182
Email	mendovic@unam.mx

Study information

Study design	Single-centre interventional double-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	https://www.zaragoza.unam.mx/proceso-inflamatorio-cronico-y-enfermedades-cronicas/
Scientific title	Effect of oral administration of resveratrol on markers of oxidative stress, inflammation and cognitive functions in a population of older adults with type 2 diabetes mellitus
Study objectives	Taking into account the scientific reports regarding the effectiveness of resveratrol intake on glycemic control and its antioxidant, anti-inflammatory and neuroprotective properties, it is assumed that the oral administration of resveratrol will improve the levels of oxidative stress markers and chronic inflammation, as well as performance in cognitive tests, in addition to stabilizing biochemical markers in patients with type 2 diabetes mellitus.
Ethics approval(s)	Approved 16/05/2021, Ethics, Bioethics and Biosafety Committee of the Research Committee of Facultad de Estudios Superiores Zaragoza, UNAM (C. Bonilla 66, Ejercito de Oriente, Delegación Iztapalapa, 09230, Mexico; +521 5556230724; div.posgrado.investigacion@zaragoza.unam.mx), ref: FESZ-CE/20-118-01
Health condition(s) or problem(s) studied	Type 2 diabetes mellitus
Intervention	The sample will be randomly divided into three groups: 1. Experimental A will receive a capsule with 500 mg of resveratrol (RV) daily for 12 months 2. Experimental B will receive two capsules with 500 mg RV daily for 12 months 3. Placebo will receive a capsule of identical appearance to those of the other groups daily for 12 months All participants must be under similar antidiabetic treatment regimens (metformin and/or glibenclamide) at the time of their inclusion in the study. All patients will be verbally informed and signed a consent form. In order to evaluate the effect of oral administration of resveratrol on cognitive functions, the following will be carried out: Rey's auditory-verbal learning test, series of digits and symbols test and the trace test. To evaluate the effect on oxidative stress markers, isoprostanes, DNA damage, total antioxidant activity and antioxidant capacity of the enzymes superoxide dismutase and glutathione peroxidase will be measured. To evaluate the effect on chronic inflammation markers, the following will be measured: CRP, IL1, IL6, TNF-a and IL10 Finally, to evaluate the degree of diabetic control, the following will be carried out: measurement of glucose levels, HBA1c, lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides), kidney profile (uric acid, creatinine, urea) and blood pressure.
Intervention type	Supplement
Primary outcome measure	Cognitive functions that are measured at the beginning and at 12 months by: 1. Rey's auditory-verbal learning test 2. The digit and symbol string test 3. The stroke test
Secondary outcome measures	1. Markers of oxidative stress measured at the beginning of the study and at 12 months using: 1.1 Isoprostanes, by enzyme-linked immunosorbent assay (ELISA) 1.2 DNA damage by alkaline electrophoresis 1.3 Total antioxidant activity, by spectrophotometric technique using a commercial kit from Randox Laboratories Ltd. 1.4 The antioxidant capacity of the enzymes superoxide dismutase and glutathione peroxidase, by spectrophotometric technique using a commercial kit from Randox Laboratories Ltd. 2. Markers of chronic inflammation at baseline and at 12 months measured using: 2.1 C-reactive protein (CRP), by nephelometry using a commercial kit from Randox Laboratories Ltd. 2.2 IL1, IL6, TNF-α and IL10, will be performed by flow cytometry with a commercial BD kit. 3. Degree of control measured at the beginning and at 12 months through levels of: 3.1 glucose, HBA1c, lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), kidney profile (uric acid, creatinine, urea) that will be carried out in an automated equipment (Selectra Junior), and commercial kits will be used (Randox Laboratories Ltd.). 3.2 Blood pressure, measured by trained nursing personnel.
Overall study start date	10/05/2020
Completion date	10/10/2022

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	120
Key inclusion criteria	1. Clinical diagnosis of diabetes mellitus type 2 2. People over 60 years of age 3. Residence in Mexico City 4. Either sex
Key exclusion criteria	1. Smoking or alcoholism 2. People who have taken antioxidant supplements or anti-inflammatories in the last 6 months 3. Without replacement hormones, in the case of women
Date of first enrolment	16/05/2020
Date of final enrolment	30/09/2022

Locations

Countries of recruitment

Guatemala
Mexico

Study participating centre

Gerontology Research Unit, FES Zaragoza (Unidad de Investigación en Gerontología, FES Zaragoza, UNAM)

Batalla 5 de mayo s/n
Esquina Fuerte de Loreto
Ejercito de Oriente
Delegación Iztapalapa
Mexico City
09230
Mexico

Sponsor information

National Autonomous University of Mexico
University/education

J.C. Bonilla 66 Ejercito de Oriente Delegación Iztapalapa
Mexico City
09230
Mexico

Phone	+52 (0)5556230724
Email	div.posgrado.investigacion@zaragoza.unam.mx
Website	http://www.unam.mx/index/en
"ROR"	https://ror.org/01tmp8f25

Funders

Funder type

University/education

Universidad Nacional Autónoma de México
Government organisation / Local government

Alternative name(s): National Autonomous University of Mexico, UNAM
Location: Mexico

Results and Publications

Intention to publish date	14/11/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The data generated during the study will be available upon request to the researcher, PhD. Mirna Ruiz Ramos, by requesting it by mail to the email address mirnar@comunidad.unam.mx, which will be available from September 2023.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		18/04/2023	09/10/2024	Yes	No

Editorial Notes

09/10/2024: Publication reference added.
13/09/2021: Trial's existence confirmed by Bioethics and Biosafety Committee of the Research Committee of Facultad de Estudios Superiores Zaragoza, UNAM.