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

NCT ID: NCT05292300

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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The main purpose of this study is to determine the efficacy of the lyophilizer-dried powder form of cornelian cherry (Cornus mas L.) grown in our country on inflammation in women with insulin resistance by biochemical parameters.

Sub-objectives of the study;

* Determining the presence of inflammation in women with insulin resistance.
* Determination of the effect of cornelian cherry on both fasting blood glucose, insulin and blood lipid profile.
* Determination of both anti-inflammatory, antidiabetic and antioxidant effects of cornelian cherry.
* Determination of the effect of cornelian cherry on anthropometric measurements.

The aim of this study is to compare the anthropometric measurements and biomarkers of women with insulin resistance as a result of the consumption of powdered cornelian cherry (Cornus mas L.) that has been freeze-dried at -55 degrees with a Lyophilizer device for 12 weeks.

Conditions

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Insulin Resistance Obesity PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Cornelian Cherry Group

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.

Group Type EXPERIMENTAL

Cornelian Cherry (Cornus mas L.)

Intervention Type DIETARY_SUPPLEMENT

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

Diet Group

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.

Group Type EXPERIMENTAL

Diet

Intervention Type 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

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.

Group Type EXPERIMENTAL

Cornelian Cherry (Cornus mas L.)

Intervention Type DIETARY_SUPPLEMENT

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

Diet

Intervention Type BEHAVIORAL

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

Interventions

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Cornelian Cherry (Cornus mas L.)

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

Intervention Type DIETARY_SUPPLEMENT

Diet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Margot Celik

Nutrition and Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Esra Güneş, PhD

Role: STUDY_DIRECTOR

Marmara University

Locations

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Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2018.652

Identifier Type: -

Identifier Source: org_study_id

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