Skip to main content
OpenTrials
Completed

NCT Number: NCT06121713

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nutrition, Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldring Centre for High Performance Sport

Toronto, Ontario, M4K1C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GCE + Low ALA

Dietary Supplement

Participants will consume a pill containing 200mg green coffee extract and 200mg alpha-lipoic acid 30 minutes before a 75g oral glucose tolerance test

GCE + High ALA

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Glucose incremental area under the curve

    Time frame: 2 hours

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

Secondary outcomes

  1. Mean glucose concentration

    Time frame: 2 hours

    Mean glucose concentration measured during an oral glucose tolerance test

  2. Insulin incremental area under the curve

    Time frame: 2 hours

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

  3. Mean insulin concentration

    Time frame: 2 hours

    mean insulin concentration measured during an oral glucose tolerance test

  4. peak glucose concentration

    Time frame: 2 hours

    peak glucose concentration measured during an oral glucose tolerance test

  5. peak insulin concentration

    Time frame: 2 hours

    peak insulin concentration measured during an oral glucose tolerance test

  6. Postprandial glucose oxidation

    Time frame: 2 hours

    Postprandial glucose oxidation measured with a metabolic tracer

  7. Appetite perceptions

    Time frame: 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

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Iovate Health Sciences International Inc

Registry information

Acronym: GCE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.