Clinical trial NCT05688917: Green Coffee Effect on Metabolic Syndrome
Official title: Effect of Green Coffee Supplementation on Inflammatory Biomarkers in Obese Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supportive Care
Metabolic Syndrome
Obesity
Hypertension
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Damanhour University
First posted: 2023-01-18
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 160 obese patients supplemented with GCBE capsules (800 mg) daily for six months
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Adiponectin (µg/mL)
timeFrame: six months
measure: TNF-α (pg/mL)
timeFrame: six months
measure: Resistin (ng/mL)
timeFrame: six months
measure: Homocysteine (µmol/L)
timeFrame: six months
measure: Hs-CRP (mg/L)
timeFrame: Six months
Secondary outcomes:
measure: BMI (kg/m2)
timeFrame: six months
measure: LDL-C (mg/dL)
timeFrame: six Months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Naglaa Khedr
state: Gharbia
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass. Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.