The Effect of Green Coffee Extract on Blood Glucose Homeostasis in Healthy Adults

NCT06137066 | Completed

• 1 other identifier: 6039146
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Green coffee extract (GCE) supplementation has been shown to induce favourable health benefits on glucose metabolism and weight management. Previous literature suggests that the benefits of GCE are due to the high bioavailability of chlorogenic acid (CGA) which is known for its antioxidant and anti-inflammatory properties but is destroyed during the bean roasting process used to make coffee in Western societies. While some studies examining chronic and high-dose GCE supplementation (4-12 weeks) report beneficial effects on glucose handling and reductions in body mass following supplementation, comparably less is known about the effect of acute (single dose) GCE supplementation. The purpose of the current study is to determine the impact of acute supplementation of GCE on blood sugar levels following consumption of a carbohydrate drink in healthy adults. A secondary objective is to evaluate the effect of GCE on insulin levels, other measures of glucose metabolism, and appetite perceptions.

Conditions

Healthy

Keywords

Green Coffee Extract; Chlorogenic Acid; Alpha-Lipoic Acid; Dihydroberberine

Outcome Measures

Primary Outcomes (1)

• 2-hour plasma glucose incremental area under the curve

  Determination of the total rise in plasma glucose during an oral glucose tolerance test, to be assessed by an enzyme-linked immunosorbent assay.

  2 hours

Secondary Outcomes (8)

• 2- hour plasma insulin incremental area under the curve

  Aggregate 2 hours during the oral glucose tolerance test

• Postprandial glucose oxidation

  Aggregate 2 hours during the oral glucose tolerance test

• Appetite perceptions

  -30 minutes, 0 minutes, 60 minutes, 120 minutes, during the oral glucose tolerance test.

• Mean glucose concentration

  2 hours

• Mean insulin concentration

  2 hours

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo supplement consisting of microcrystalline cellulose with 5mg magnesium stearate and 5mg silicon dioxide.

Dietary Supplement: Placebo

200mg GCE +200mg ALA

EXPERIMENTAL

200mg green coffee extract +200mg alpha-lipoic acid

Dietary Supplement: 200mg GCE +200mg ALA

200mg GCE +400mg ALA

EXPERIMENTAL

200mg green coffee extract +200mg alpha-lipoic acid

Dietary Supplement: 200mg GCE +400mg ALA

200mg GCE +200mg DHB

EXPERIMENTAL

200mg green coffee extract + 200mg dihydroberberine

Dietary Supplement: 200mg GCE + 200mg DHB

Interventions

200mg GCE +200mg ALA DIETARY_SUPPLEMENT

200mg green coffee extract + 200mg alpha-lipoic acid

200mg GCE +200mg ALA

200mg GCE +400mg ALA DIETARY_SUPPLEMENT

200mg green coffee extract + 400mg alpha-lipoic acid

200mg GCE +400mg ALA

200mg GCE + 200mg DHB DIETARY_SUPPLEMENT

200mg green coffee extract + 200mg dihydroberberine

200mg GCE +200mg DHB

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose with 5 mg magnesium stearate and 5 mg silicon dioxide

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females 18-45 years
• BMI between 18.5-30 kg/m2
• No history of smoking or cardiovascular and metabolic diseases (stroke, hypertension, type II diabetes) or other diseases that could impact the study outcomes
• Weight stable (within ±2kg for 6 months)
• Generally healthy as assessed by medical and physical activity questionnaires
• No oral contraceptive use except for triphasic contraceptives

You may not qualify if:

• Any concurrent medical, psychiatric, or orthopedic condition that, subject to investigators' discernment, would negatively affect the subject's ability to comply with the study requirements
• Any history of cardiovascular, neurological, respiratory, skeletal muscle or metabolic disease
• Using medication to manage blood glucose or lipid metabolism
• Bleeding disorders or antiplatelet/ anticoagulation therapy
• Currently using (or use within the last 3 months) monophasic or biphasic oral contraceptives
• Currently supplementing with GCE, ALA, or dihydroberberine
• Any known allergies to green coffee extract, alpha-lipoic acid, dihydroberberine or berberine, or supplementing within the last 3 months
• Currently pregnant or lactating
• Have irregular menstrual cycles (\<21 days or \>35 days)
• Any form of cancer currently or in the last 5 years
• Are recreational smokers of any form (tobacco or cannabis)
• Use of corticosteroids, testosterone replacement therapy, or any anabolic steroid
• Not willing to consume the 24-hour control diet prior to metabolic trials
• Any current Illness which could interfere with the study (e.g., prolonged diarrhea, regurgitation, etc.)

Sponsors & Collaborators

• Dr. Chris McGlory, PhD: lead
• Iovate Health Sciences International Inc: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Interventions

dihydrodibutylstilbestrol

Study Officials

• Chris McGlory

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplements will be coded as either 'A', 'B', 'C', or 'D'. A third-party researcher not involved in data collection will store the code key and only reveal the information after the data has been analyzed to maintain the double-blinded nature of the trial.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Four-arm study. All participants receive all acute nutritional interventions: placebo (microcrystalline cellulose with 5mg magnesium stearate and 5mg silicon dioxide), 200mg GCE +200mg ALA, 200mg GCE + 400mg ALA, 200mg GCE + 200mg dihydroberberine.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)