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

Sponsor
University of Toronto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06121713
Collaborator
Iovate Health Sciences International Inc (Industry)
20
3
7.5

Study Details

Study Description

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. Whilst some studies examining chronic and high dose GCE supplementation (4-12 weeks) report beneficial effects on glucose metabolism and reductions in body mass following supplementation, comparably less is known about the effect of acute (single dose) GCE supplementation. Another natural compound, alpha-lipoic acid (ALA) has antioxidant properties and may also benefit glucose metabolism. The purpose of the current study is to determine the impact of acute supplementation of GCE with ALA on postprandial blood glucose concentration following consumption of a carbohydrate drink in healthy adults. A secondary objective is to evaluate the effect of GCE+ALA on blood insulin concentrations, insulin sensitivity, glucose oxidation, and perceptions of appetite.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: GCE + Low ALA
  • Dietary Supplement: GCE + High ALA
  • Dietary Supplement: Placebo
N/A

Detailed Description

The primary purpose of this study is to determine if GCE combined with ALA supplementation influences postprandial glucose metabolism. Participants will complete 3 visits to the investigator's laboratory at the University of Toronto. On each occasion, participants will consume a sugary drink (75g sugar) and investigators will take blood and breath samples for 2 hours. Participants will also be asked to fill out some questionnaires about appetite during this time. Thirty minutes before consuming the sugary drink, participants will consume one of the following pill supplements in a randomized order: 1) 200mg CGE + 200mg ALA; 2) 200mg GCE

  • 400mg ALA; or 3) Placebo (no CGE or ALA).

The study will advance knowledge regarding the effects of GCE and ALA on postprandial glycemia and insulin sensitivity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Green Coffee Extract Combined With Alpha-Lipoic Acid on Blood Glucose Homeostasis in Healthy Adults
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GCE + Low ALA

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

Dietary Supplement: GCE + Low ALA
Participants will consume a pill containing 200mg green coffee extract and 200mg alpha-lipoic acid 30 minutes before a 75g oral glucose tolerance test

Active Comparator: GCE + High ALA

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

Dietary Supplement: GCE + High ALA
Participants will consume a pill containing 200mg green coffee extract and 400mg alpha-lipoic acid 30 minutes before a 75g oral glucose tolerance test

Placebo Comparator: Placebo

Inert placebo pill prior to an oral glucose tolerance test

Dietary Supplement: Placebo
Participants will consume a placebo pill (500mg insoluble microcrystalline cellulose, 5mg magnesium stearate, 5mg silicon dioxide) prior to a 75g oral glucose tolerance test

Outcome Measures

Primary Outcome Measures

  1. Glucose incremental area under the curve [2 hours]

    glucose incremental area under the curve measured during an oral glucose tolerance test

Secondary Outcome Measures

  1. Mean glucose concentration [2 hours]

    Mean glucose concentration measured during an oral glucose tolerance test

  2. Insulin incremental area under the curve [2 hours]

    insulin incremental area under the curve measured during an oral glucose tolerance test

  3. Mean insulin concentration [2 hours]

    mean insulin concentration measured during an oral glucose tolerance test

  4. peak glucose concentration [2 hours]

    peak glucose concentration measured during an oral glucose tolerance test

  5. peak insulin concentration [2 hours]

    peak insulin concentration measured during an oral glucose tolerance test

  6. Postprandial glucose oxidation [2 hours]

    Postprandial glucose oxidation measured with a metabolic tracer

  7. Appetite perceptions [2 hours]

    Visual analog scales (0-100) will be used to determine perceptions of hunger, satisfaction, fullness, and prospective food consumption with higher scores denoting increased perceptions.

  8. Insulin sensitivity [2 hours]

    insulin sensitivity measured via the Matsuda Index during an oral glucose tolerance test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18-45 years

  • BMI 20 - 30 kg/m2

  • Weight stable (within ± 2kg for at least 6 months)

  • Experiencing monthly menstrual periods (eumenorrheic) if female

  • Non-smoker

Exclusion Criteria:
  • Previous history of cardiovascular or metabolic disease

  • Use of medication for managing blood glucose or lipid metabolism

  • Current use of monophasic or biphasic oral contraceptives within the last 3 months (triphasic oral contraceptives are okay)

  • Current supplementation of green coffee extract or supplementing in the last 3 months

  • Irregular menstrual cycles (<21 days or >35 days)

  • Pregnant or lactating

  • Recreational smoking of any form (tobacco or cannabis)

  • Not willing to consume the 24-hour control diet prior to metabolic trials

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Toronto
  • Iovate Health Sciences International Inc

Investigators

  • Principal Investigator: Jenna Gillen, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jenna Gillen, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier:
NCT06121713
Other Study ID Numbers:
  • 44741
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 9, 2023