Daily supplement of 2 g cinnamomum zeylanicum orally (capsules) for a period of 90 days

Daily placebo capsules orally (wheat flour without any active compound) for a period of 90 days.

Type 2 Diabetes

Capsules of 2 g cinnamomum zeylanicum orally

Cinnamomum zeylanicum

Placebo

C.A.A.P.S.

ISSSTE Family Medicine Clinic

Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes

Evaluation of the Effect of Cinnamomum Zeylanicum on Glycemic Levels of Mexican Adult Patients With Type 2 Diabetes at 3 Months: Randomized Clinical Trial

Julio Alfredo Garcia Puga

Principal Investigator

Universidad de Sonora

Randomized Controlled Trial This is a simple blind randomized clinical trial with patients with type 2 diabetes, the subjects will be divided into two groups, the intervention supplemented with 2 g daily of cinnamomum zeylanicum orally (capsules) and the control group with a placebo. There will be a follow-up of 3 months every two weeks to measure the variables of interest in the study.

A simple blinding (participants blinded to the belonging group). The person who will randomize the participants will not be involved in the recruitment of participants. This will be done when we have the total sample of participants.

A group of 14 patients (7 women and 7 men) with DM2 without adequate control, treated with metformin 850mg daily, who will receive 1g of cinnamomum cassia orally every 8 hours, for 90 days.

A group of 14 patients (7 women and 7 men) with DM2 without adequate control, treated with metformin 850mg daily, who will receive 1g of placebo (calcined magnesia) orally every 8 hours, for 90 days.

Diabetes Mellitus, Type 2

The sample size will be 28 patients, 14 men and 14 women.

The intervention period will be 90 days, unlike other trials with Cinnamomum cassia and the main effect sought is on IGF1 levels, in addition to metabolic control.

Cinnamomum Cassia

The intervention period will be 90 days, unlike other trials with Cinnamomum cassia and comparison with placebo. The main effect sought is on IGF1 levels, in addition to metabolic control.

Placebo (calcined magnesia)

Pubchem; 2017.Accessed at https://pubchem.ncbi.nlm.nih.gov on 15 June 2017.

Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.

Cinnamomum Cassia Effect on IGF1 and Metabolic Control in Patients With DM2 Without Glycemic Control Metformin Treated

Effect of Cinnamomum Cassia as an Enhancer of the Insulin Response of the Insulin-Like Growth Factor-1 and Metabolic Control in Patients With Type 2 Diabetes Mellitus Treated With Metformin Without Glycemic Control

Changes in the levels of the fasting glucose decrease and glycated hemoglobin

Changes in the levels of total cholesterol

Changes in the levels of systolic and diastolic blood pressure

All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)

Sandra Ofelia Hernández González

Medical Research Associate C, Unit in Clinical Epidemiology, Specialities Hospital, Medical Unit of High Specialty; West National Medical Center, Mexican Institute of Social Security.

Coordinación de Investigación en Salud, Mexico

Controlled clinical trial, of two parallel groups, double blind, with random assignment and control group.
Process:
Visit 1 / Day -7: Period of scrutiny, study information, consent signature, clinical history, anthropometry, baseline laboratory tests.
Visit 2 / Day 0: Start the intervention period, simple random assignment for study groups, delivery of medication, general recommendations of diet and exercise.
Visit 3 / Day 30 - Visit 4 / Day 60: Adherence to treatment, taking laboratory tests, evaluation of adverse events, general recommendations of diet and exercise, general recommendations of diet and exercise will be evaluated.
Final Visit / Day 90 ± 7: Anthropometric measurements will be taken, laboratory tests will be taken, treatment adherence and adverse events will be evaluated, end of the intervention period.

Random assignment of groups and blinding:
All participants will be submitted to the selection of a sealed envelope which will have a numerical code previously defined by a third party for each intervention group.
The total number of envelopes required to complete the minimum number of participants (28) will be divided according to sex in two boxes, there will be 14 envelopes for men and 14 envelopes for women, with numerical codes that identify the bottle of intervention treatment that should receive the participant during the intervention period. They will be divided into 7 blinded codes for cinnamomum cassia group and 7 for placebo to complete the size of each subsample. Chance guarantees blinding, neither the participant nor the researcher will know the type of treatment. The database for the blinded statistical analysis will be completed. The blind man will be removed once the statistical analysis has been completed.

5 capsules of placebo (microcrystalline cellulose) taken once in the morning with breakfast and once in the evening with dinner for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal

For presentation to volunteers, the daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:
EnduraCell broccoli sprout powder: 3 capsules
Bulk Powders Green tea extract: 1 capsule
Bulk Powders Cinnamon Bark Extract: 1 capsule to be taken for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal

Dietary Supplementation During Exercise

Microcrystalline cellulose capsules x 5 morning and night with meals for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal

Daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:
EnduraCell broccoli sprout powder: 3 capsules
Bulk Powders Green tea extract: 1 capsule
Bulk Powders Cinnamon Bark Extract: 1 capsule taken for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal

Intervention

University of Aberdeen, The Rowett Institute

ADAPT: Efficacy of a Dietary Supplement During and After Exercise

ADAPT: Efficacy of a Dietary Supplement to Increase Resilience and Inhibit the Oxidative Stress Response During and After Exercise

Plasma TBARS:Plasma TBARS will be measured by HPLC (High Performance Liquid Chromatography).

Glutathione peroxidase, superoxide dismutase, and acetaldehyde dehydrogenase will be measured in plasma by spectrophotometer.

Plasma F2-Isoprostanes: will be measured by ELISA.

Plasma high sensitivity C-Reactive Protein (hs-CRP): Plasma hsCRP will be assessed by automated analysis using KONE.

Plasma insulin: Plasma insulin will be assessed by ELISA.

Plasma glucose will be assessed by automated analysis using KONE.

Will be measured by automated analysis using KONE.

Plasma Creatine Kinase activity will assessed by spectrophotometer Plasma Lactate dehydrogenase activity will assessed by spectrophotometer

This is a test of lower body strength and will be assessed throughout the study visits using a vertical jump meter.

Questionnaires to be applied during exercise challenge test days

To assess lifestyle factors such as fatigue, sleep, and mood.

Rating of perceived soreness (pre, post, 48hr post) - Volunteers will rate their perceived soreness in their quadriceps on a ten point scale.

Ratings of perceived exhaustion (during exercise challenge) - Volunteers will rate their perceived exhaustion using Borg's modified R.P.E scale (10 point).

cinnamomum camphora/antioxidant

Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes

Cinnamomum Cassia Effect on IGF1 and Metabolic Control in Patients With DM2 Without Glycemic Control Metformin Treated

ADAPT: Efficacy of a Dietary Supplement During and After Exercise

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