Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance

NCT05292300 | Completed

• 1 other identifier: 09.2018.652
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of 3 months supplementation of lyophilize dried cornelian cherry (Cornus mas L.) on women diagnosed with insulin resistance. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.

Conditions

Insulin Resistance; Obesity; PreDiabetes

Keywords

Cornelian Cherry; Cornus mas L.; Insulin Resistance; Nutrition; Anthropometry

Outcome Measures

Primary Outcomes (5)

• Change from Baseline in the Fasting Blood Glucose (mg/dl) at 12 weeks

  The fasting blood glucose (mg/dl) at the baseline and 12 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 3 months), Cornelian Cherry and Diet Group (who received additional 20 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 20 g/day of dried powdered Cornelian Cherry ).

  3 months

• Change from Baseline in the Fasting Insulin (mU/L) at 12 weeks

  The fasting insulin (mU/L) values of the women with insulin resistance at the baseline and 12 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 3 months), Cornelian Cherry and Diet Group (who received additional 20 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 20 g/day of dried powdered Cornelian Cherry ).

  3 months

• Change from Baseline in the HOMA-IR at 12 weeks

  The fasting blood glucose (mg/dl) and fasting insulin (mU/L) values of the women with insulin resistance at the baseline and 12 weeks later will be taken noted from the routinely requested tests in the hospital. HOMA-IR will be calculated with the formula (fasting glucose (mg/dl) x fasting insulin (mU/L)) / 405. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 3 months), Cornelian Cherry and Diet Group (who received additional 20 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 20 g/day of dried powdered Cornelian Cherry ).

  3 months

• Change from Baseline in the BMI (kg/m2)

  The body weight (kg) and height (m) of the women with insulin resistance at the baseline, 4 weeks, 8 weeks and 12 weeks will be taken by the researcher and noted in their files. The height of the patients will be measured with a fixed height meter with 0.5 cm intervals, with shoes off. For body analysis, an 8-electrode bioelectrical impedance (BIA) device Tanita MC 780 MA, which performs segmental analysis, will be used. Patients will be asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.), any heavy clothing, shoes, and socks before stepping on the device. The device is set to -1.0 kg for the remaining clothes. From these measurements, body weight, body fat (kg), body fat percentage (%), body muscle (kg) and body water (kg) values will be recorded. Body mass index (BMI) will be calculated as weight (kg) divided by height (m) squared.

  3 months

• Change from Baseline in the Anthropometric Measurements

  The anthropometric measurements of the women with insulin resistance at the baseline, 4, 8 and 12 weeks will be taken by the researcher. These measurements are; waist circumference(cm), hip circumference(cm), mid-upper arm circumference(cm), neck circumference(cm), waist to height ratio(cm) and waist to hip ratio(cm). Waist circumference will be measured using an inflexible tape at the umbilicus level after normal exhalation to the nearest 0-1 cm. Hip circumference will be measured from the widest area between the waist and the thigh. The waist-to-hip will be calculated from the formula waist(cm)/hip(cm) and waist-to-height ratios will be calculated from the formula waist(cm)/height(cm). Middle-upper arm circumference will be measured on the left arm of the patients. Neck circumference will be measured with the shoulders in the free position from the point where the thyroid cartilage is most protruding.

  3 months

Study Arms (4)

Control Group

NO INTERVENTION

Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group.

Cornelian Cherry Group

EXPERIMENTAL

Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group. Patients in this group will receive 20 g/day Cornelian Cherry powder.

Dietary Supplement: Cornelian Cherry (Cornus mas L.)

Diet Group

EXPERIMENTAL

Among those who applied to the clinic, those who want to follow their diet will be randomized into this group. Patients in this group will be followed by a personalized diet.

Behavioral: Diet

Cornelian Cherry and Diet Group

EXPERIMENTAL

Among those who applied to the clinic, those who want to follow their diet will be randomized into this group. Patients in this group will be followed by a personalized diet and will receive 20 g/day Cornelian Cherry powder for their one portion fruit a day.

Dietary Supplement: Cornelian Cherry (Cornus mas L.); Behavioral: Diet

Interventions

Cornelian Cherry (Cornus mas L.) DIETARY_SUPPLEMENT

Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement.

Cornelian Cherry Group; Cornelian Cherry and Diet Group

Diet BEHAVIORAL

Patient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician.

Cornelian Cherry and Diet Group; Diet Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18 and 45 years with insulin resistance.
• Those who have not experienced menopause
• Those who applied to the obesity clinic
• Volunteers
• Those who signed the consent form

You may not qualify if:

• Those who use medicine for diabetes and thyroid diseases,
• Those taking hormone therapy
• Pregnant and lactating women
• Those with a history of cancer
• Patients with communication problems.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Prediabetic State

Interventions

Diet

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fatma Esra Güneş, PhD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutrition and Dietetics

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: March 23, 2022
• Study Start: May 24, 2021
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)