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GCE + Low ALA for Healthy Nutrition (GCE Trial)

N/A

Recruiting

Led By Jenna Gillen, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Awards & highlights

GCE Trial Summary

This trial aims to study the effects of a single dose of green coffee extract (GCE) combined with alpha-lipoic acid (ALA) on blood sugar levels after consuming a carbohydrate drink in healthy

Who is the study for?

This trial is for healthy adults aged 18-45 with a BMI of 20-30 kg/m2, who have maintained their weight within ±2kg for the last six months. Women must be experiencing regular menstrual cycles and participants should not smoke.Check my eligibility

What is being tested?

The study tests how green coffee extract (GCE) combined with different levels of alpha-lipoic acid (ALA) affects blood sugar control after drinking a carbohydrate drink. It compares high ALA+GCE, low ALA+GCE, and placebo groups to see effects on blood glucose and insulin levels, sensitivity, oxidation, and appetite perception.See study design

What are the potential side effects?

Potential side effects are not specified in the provided information but could include digestive discomfort or allergic reactions due to GCE or ALA's antioxidant properties.

GCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose incremental area under the curve

Secondary outcome measures

Appetite perceptions

Insulin incremental area under the curve

Insulin sensitivity

+5 more

GCE Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: GCE + Low ALAActive Control1 Intervention

Green coffee extract and a low dose of alpha-lipoic acid prior to an oral glucose tolerance test

Group II: GCE + High ALAActive Control1 Intervention

Green coffee extract and a moderate dose of alpha-lipoic acid prior to an oral glucose tolerance test

Group III: PlaceboPlacebo Group1 Intervention

Inert placebo pill prior to an oral glucose tolerance test

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

690 Previous Clinical Trials

1,019,623 Total Patients Enrolled

Iovate Health Sciences International IncIndustry Sponsor

5 Previous Clinical Trials

179 Total Patients Enrolled

Jenna Gillen, PhDPrincipal InvestigatorUniversity of Toronto

3 Previous Clinical Trials

139 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for participation in this research study?

"As recorded on clinicaltrials.gov, this medical investigation is actively seeking suitable candidates. It was initially posted for recruitment purposes on February 8th, 2024 and most recently updated on March 19th of the same year."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this study?

"This medical research study is currently open to enrollment for 20 individuals aged between 18 and 45, who are presently maintaining a healthy dietary intake. Potential participants must fulfill the subsequent conditions: Age ranging from 18 to 45 years, Body Mass Index (BMI) falling within the range of 20 - 30 kg/m2, Steady weight (with fluctuations not exceeding ±2kg over a period lasting at least half a year), Regular monthly menstrual cycles for females (eumenorrheic status), Non-engagement in smoking activities."

Answered by AI

Does this particular research study include individuals who are 75 years of age or older?

"Inclusion in this study mandates that participants are between 18 and 45 years old. There are a total of 14 trials targeting individuals under 18 years old, and 34 focusing on those above the age of 65."

Answered by AI

What is the aggregate count of individuals currently enrolled in this clinical investigation?

"Indeed, the details available on clinicaltrials.gov confirm that this research endeavor is actively seeking eligible participants. Originally shared on February 8th, 2024, and most recently revised on March 19th, 2024. The investigation aims to enroll a total of 20 individuals from a sole designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Green Coffee Extract Combined With Alpha-Lipoic Acid on Blood Glucose Homeostasis in Healthy Adults

Jenna Gillen 2024. "Effect of Green Coffee Extract Combined With Alpha-Lipoic Acid on Blood Glucose Homeostasis in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121713.