Green Coffee Effect on Metabolic Syndrome

NCT05688917 | Completed

• 1 other identifier: FPTU-11-2020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Supportive Care; Metabolic Syndrome; Obesity; Hypertension

Outcome Measures

Primary Outcomes (5)

• Adiponectin (µg/mL)

  Serum Level

  six months

• TNF-α (pg/mL)

  Serum Level

  six months

• Resistin (ng/mL)

  Serum Level

  six months

• Homocysteine (µmol/L)

  Serum Level

  six months

• Hs-CRP (mg/L)

  Serum Level

  Six months

Secondary Outcomes (2)

• BMI (kg/m2)

  six months

• LDL-C (mg/dL)

  six Months

Study Arms (2)

green been extract treated group

EXPERIMENTAL

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

Dietary Supplement: Green coffee been extract

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Green coffee been extract DIETARY_SUPPLEMENT

supportive treatment

green been extract treated group

Placebo OTHER

Placebo capsule

Placebo group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead
• Damanhour University: collaborator

Study Sites (1)

Naglaa Khedr

Tanta, Gharbia Governorate, 35127, Egypt

Location

Related Publications (4)

• 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.

  PMID: 36231426 BACKGROUND

• 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.

  PMID: 29307310 RESULT

• 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.

  PMID: 36381474 RESULT

• 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.

  PMID: 39468643 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Hypertension

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rehab H Werida, Ass. Prof.

  Damanhour University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind randomised controlled study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biochemistry

Model Details: 160 obese patients supplemented with GCBE capsules (800 mg) daily for six months

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 18, 2023
• Study Start: September 3, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months
• Access Criteria: data after analysis

Locations

EG (1)