Effect of Cocoa Supplementation Peripheral and Autonomic Diabetic Neuropathy

NCT05247034 | Completed Results

• 2 other identifiers: 202103202094
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

Type 2 diabetes mellitus is a high incidence disease in Mexico and is associated with the development of chronic degenerative complications such as diabetic neuropathy. The latter manifests itself as a set of disorders that occur as a consequence of a chronic hyperglycemic state that can induce oxidative stress and inflammation, resulting in damage to the autonomic and peripheral nervous system. In Mexico, it has been reported that this complication usually occurs between 29% and 90% of patients with diabetes. Cocoa is a food with a high content of flavonoids, which are phenolic compounds with antioxidant and anti-inflammatory effects. Additionally, its consumption has been associated with a decrease in hyperglycemia and insulin resistance, improvement in mitochondrial function, and, based on the above, an effect on diabetic complications has been suggested; This has been demonstrated in in vivo and in vitro models, but not in the human population. Once the symptoms of diabetic neuropathy have started, palliative treatments are prescribed, and to date there are no pharmacological compounds that have been shown to reverse the consequences of diabetic peripheral and autonomic neuropathy. Additionally, clinical trials of compounds with antioxidant properties have only performed subjective evaluations based on questionnaires on the perception of the improvement of diabetic neuropathy and some biochemical markers or nerve conduction tests, however, the results shown have not been conclusive. This is why a double-blind, randomized controlled clinical trial is proposed, with the objective of evaluating the effect of cocoa supplementation in patients with type 2 diabetes mellitus and peripheral and autonomic diabetic neuropathy on a) the biochemical profile, which includes the evaluation of the glycemic and lipid profile, quantification of pro-inflammatory cytokines and oxidative stress markers; b) the clinical profile through the application of standardized questionnaires, anthropometric measurements and blood pressure, and c) somatosensory processing through the paired pulse H reflex test. The hypothesis of this study is that cocoa supplementation will have a beneficial effect on the biochemical and clinical profile and somatosensory processing of peripheral and autonomic diabetic neuropathy.

Conditions

Diabetic Neuropathies

Keywords

Cocoa; Diabetic neuropathy; H-reflex; Cardiometabolic risk factor; Polyphenols; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Toronto Clinical Scoring System (TCSS)

  It is a system of clinical evaluations carried out by the researcher to identify peripheral neuropathy, assigning a score to symptomatology, reflexes and sensory tests. For the purposes of this study, the total score, i.e., the sum of all units on the scale, is reported. The minimum score that can be obtained is 0 points, while the maximum is 19 points. This means that the higher the score, the greater the severity (no grades were established based on the severity of the neuropathy). For the data represented in the row "Change from baseline at Week 12", it is the delta of the final measurement vs. the initial measurement, that is, the final measurement minus the baseline measurement.

  At baseline and after 12 weeks

Secondary Outcomes (17)

• Rate-dependent Depression of the H-reflex

  At baseline and after 12 weeks

• BEST Questionnaire

  At baseline, after 4, 8 and 12 weeks

• Bristol Stool Form Scale

  At baseline and 12 weeks

• Weight

  At baseline, after 4, 8 and 12 weeks

• Waist Circumference

  At baseline, after 4, 8 and 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Diet for patients with diabetes + 4 capsules of cocoa powder, 500 mg each, daily for 12 weeks.

Dietary Supplement: Cocoa

Control group

PLACEBO COMPARATOR

Diet for patients with diabetes + 4 capsules of methylcellulose 500 mg each, daily for 12 weeks.

Other: Placebo

Interventions

Cocoa DIETARY_SUPPLEMENT

Each capsule of cocoa powder contains 12.5 mg of flavonoids, providing a total of 50 mg per day.

Intervention group

Placebo OTHER

Each capsule contains 500 mg of methylcellulose

Control group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 40-60 years with a diagnosis of type 2 diabetes mellitus and diabetic neuropathy
• Minimum time of diagnosis of T2DM of 5 years
• Who have a Michigan Neuropathy Screening Instrument (MNSI) score ≥2
• Male and Female
• Have them sign the informed consent letter

You may not qualify if:

• Subjects who modify their pharmacological treatment during the study
• Subjects who do not attend one of the intermediate consultations

Sponsors & Collaborators

• Anahuac University: lead

Study Sites (3)

Universidad Anáhuac México Norte

Huixquilucan, State of Mexico, 52786, Mexico

Location

Centro de Especialidades del Riñón

Naucalpan, State of Mexico, 53100, Mexico

Location

Clínica de Medicina Familiar "Nueva Oxtotitlán" ISSSTE

Toluca, State of Mexico, 50100, Mexico

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Evaluation of inflammation and oxidative stress parameters was proposed, however, given the cost involved, neutrophil/lymphocyte ratio was used as a marker of inflammation, but oxidative stress was not measured. It was necessary to include different centers for recruiting potential candidates. The follow-up period was established based on human resources and the budget; however, it can be considered a short time to identify significant differences in outcomes such as RDD of the H-reflex.

Results Point of Contact

• Title: Dr. Carlos Alberto Cuéllar Ramos
• Organization: Universidad Anáhuac México Norte

carlos.cuellarra@anahuac.mx

5556270210

Study Officials

• Carlos Cuéllar-Ramos, PhD

  Anahuac University

  STUDY DIRECTOR

• Gabriela Gutiérrez-Salmeán, PhD

  Anahuac University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 18, 2022
• Study Start: June 4, 2021
• Primary Completion: June 30, 2024
• Study Completion: September 3, 2024
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Locations

ME (3)