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Supportive CareNCT05688917

Green Coffee Effect on Metabolic Syndrome

A study testing Green coffee been extract in people with Supportive Care and Metabolic Syndrome, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Supportive Care, Metabolic Syndrome, Obesity
What is being tested?
Green coffee been extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteEgypt
Study dates
3 Sep 2020to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Naglaa Khedr

    Tanta, Gharbia Governorate, 35127

Other trials in Egypt

About this study

Official title: Effect of Green Coffee Supplementation on Inflammatory Biomarkers in Obese Patients With Metabolic Syndrome

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

Read the 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

Being tested
Green coffee been extract, Placebo
Medical subject headings
Metabolic Syndrome, Obesity, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Green coffee been extractDietary supplement

    supportive treatment

  • PlaceboOther

    Placebo capsule

Study groups in NCT05688917
Study groupRoleWhat they receive
green been extract treated groupExperimentalParticipants included in the study were maintained on a balanced diet and supplemented with Green Coffee Bean (Coffea Arabica) extract capsules (800 mg/capsule
Receives: Dietary Supplement: Green coffee been extract
Placebo groupPlacebo comparatorParticipants included in the study were maintained on a balanced diet and supplemented with placebo capsules.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adiponectin (µg/mL)

    Serum Level

    Measured: six months

  2. TNF-α (pg/mL)

    Serum Level

    Measured: six months

  3. Resistin (ng/mL)

    Serum Level

    Measured: six months

  4. Homocysteine (µmol/L)

    Serum Level

    Measured: six months

  5. Hs-CRP (mg/L)

    Serum Level

    Measured: Six months

Secondary outcomes (2)

  1. BMI (kg/m2)

    Weight / hight squared.

    Measured: six months

  2. LDL-C (mg/dL)

    calculated according to Friedewald formula.

    Measured: six Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start3 Sep 2020
  3. Primary completion1 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
160 obese patients supplemented with GCBE capsules (800 mg) daily for six months
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688917
Sponsor's protocol ID
FPTU-11-2020
Status last verified
May 2023
First submitted
24 Jan 2021
Last updated
26 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Not applicable. the data will published in specialized journal

Publications

  • 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.

    PubMed 36231426

  • 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.

    PubMed 29307310

  • 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.

    PubMed 36381474

  • 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.

    PubMed 39468643

Questions about this trial

What is this clinical trial studying?

A study testing Green coffee been extract in people with Supportive Care and Metabolic Syndrome, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adiponectin (µg/mL) (time frame: six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05688917, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.

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