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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06121713
Acronym
GCE
Enrollment
20
Registered
2023-11-08
Start date
2024-02-08
Completion date
2024-06-28
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Healthy

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.

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.

Interventions

DIETARY_SUPPLEMENTGCE + 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

DIETARY_SUPPLEMENTGCE + 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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Iovate Health Sciences International Inc
CollaboratorINDUSTRY
University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Glucose incremental area under the curve2 hoursglucose incremental area under the curve measured during an oral glucose tolerance test

Secondary

MeasureTime frameDescription
Insulin incremental area under the curve2 hoursinsulin incremental area under the curve measured during an oral glucose tolerance test
Mean insulin concentration2 hoursmean insulin concentration measured during an oral glucose tolerance test
peak glucose concentration2 hourspeak glucose concentration measured during an oral glucose tolerance test
Mean glucose concentration2 hoursMean glucose concentration measured during an oral glucose tolerance test
Postprandial glucose oxidation2 hoursPostprandial glucose oxidation measured with a metabolic tracer
Appetite perceptions2 hoursVisual analog scales (0-100) will be used to determine perceptions of hunger, satisfaction, fullness, and prospective food consumption with higher scores denoting increased perceptions.
Insulin sensitivity2 hoursinsulin sensitivity measured via the Matsuda Index during an oral glucose tolerance test
peak insulin concentration2 hourspeak insulin concentration measured during an oral glucose tolerance test

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026