Green Coffee Effect on Metabolic Syndrome

NCT ID: NCT05688917

Last Updated: 2023-05-26

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2022-09-30

Brief Summary

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The present study aimed to investigate the effect of green coffee bean extract (GCBE) on the inflammatory biomarkers in obese patients with a metabolic syndrome via analyzing some inflammatory biomarkers as resistin, TNF-α, total sialic acid, homocysteine, high sensitivity C-reactive protein (hs-CRP) and anti-inflammatory cytokine, adiponectin

Detailed Description

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160 obese patients supplemented with either GCBE capsules (800 mg) daily or placebo for 6 months and advised to take a balanced diet. Blood samples were collected at baseline and after three months of supplementation

Conditions

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Supportive Care Metabolic Syndrome Obesity Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

160 obese patients supplemented with GCBE capsules (800 mg) daily for six months
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
double-blind randomised controlled study

Study Groups

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green been extract treated group

Participants included in the study were maintained on a balanced diet and supplemented with Green Coffee Bean (Coffea Arabica) extract capsules (800 mg/capsule

Group Type EXPERIMENTAL

Green coffee been extract

Intervention Type DIETARY_SUPPLEMENT

supportive treatment

Placebo group

Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsule

Interventions

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Green coffee been extract

supportive treatment

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Participants were enrolled if they were

* aged 20-60y
* waist circumference \>102 cm in male; 88 cm in female
* triglycerides ≥150 mg/dL (1.7 mmol/L)
* HDL-C\<40 mg/dL (1.03 mmol/L) in males \& \<50 mg/dL (1.29 mmol/L) in females
* systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg.

Exclusion Criteria

* liver, kidney, coronary artery disease, type I diabetes, autoimmune diseases, cancer, infection, smoking, recent major surgery, routine coffee consumption, pregnancy or breast-feeding, use of anti-inflammatory drugs, corticosteroids, hormone replacement therapy, weight-loss and anti-hypercholesterolemic medications three months or less prior to enrolment
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damanhour University

OTHER

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Naglaa Khedr

Professor of Biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rehab H Werida, Ass. Prof.

Role: STUDY_CHAIR

Damanhour University

Locations

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Naglaa Khedr

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Lange E, Keszycka PK, Palkowska-Gozdzik E, Billing-Marczak K. Comparison of Glycemic Response to Carbohydrate Meals without or with a Plant-Based Formula of Kidney Bean Extract, White Mulberry Leaf Extract, and Green Coffee Extract in Individuals with Abdominal Obesity. Int J Environ Res Public Health. 2022 Sep 25;19(19):12117. doi: 10.3390/ijerph191912117.

Reference Type BACKGROUND
PMID: 36231426 (View on PubMed)

Roshan H, Nikpayam O, Sedaghat M, Sohrab G. Effects of green coffee extract supplementation on anthropometric indices, glycaemic control, blood pressure, lipid profile, insulin resistance and appetite in patients with the metabolic syndrome: a randomised clinical trial. Br J Nutr. 2018 Feb;119(3):250-258. doi: 10.1017/S0007114517003439. Epub 2018 Jan 8.

Reference Type RESULT
PMID: 29307310 (View on PubMed)

Meshkani M, Saedisomeolia A, Yekaninejad M, Mousavi SA, Ildarabadi A, Vahid-Dastjerdi M. The Effect of Green Coffee Supplementation on Lipid Profile, Glycemic Indices, Inflammatory Biomarkers and Anthropometric Indices in Iranian Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. Clin Nutr Res. 2022 Oct 28;11(4):241-254. doi: 10.7762/cnr.2022.11.4.241. eCollection 2022 Oct.

Reference Type RESULT
PMID: 36381474 (View on PubMed)

Khedr NF, Zahran ES, Ebeid AM, Melek ST, Werida RH. Effect of green coffee on miR-133a, miR-155 and inflammatory biomarkers in obese individuals. Diabetol Metab Syndr. 2024 Oct 28;16(1):256. doi: 10.1186/s13098-024-01478-7.

Reference Type DERIVED
PMID: 39468643 (View on PubMed)

Other Identifiers

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FPTU-11-2020

Identifier Type: -

Identifier Source: org_study_id

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