Nutrition, HealthyGCENCT06121713
Effect of Green Coffee Extract Combined With Alpha-Lipoic Acid on Blood Glucose Homeostasis in Healthy Adults
A study testing GCE + Low ALA and GCE + High ALA in people with Nutrition, Healthy, run by University of Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- GCE + Low ALA and GCE + High ALA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2024to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M4K1C8
About this study
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.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- GCE + Low ALA, GCE + High ALA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCE + Low ALADietary 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 ALADietary 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
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| GCE + Low ALA | Active comparator | Green coffee extract and a low dose of alpha-lipoic acid prior to an oral glucose tolerance test Receives: Dietary Supplement: GCE + Low ALA |
| GCE + High ALA | Active comparator | Green coffee extract and a moderate dose of alpha-lipoic acid prior to an oral glucose tolerance test Receives: Dietary Supplement: GCE + High ALA |
| Placebo | Placebo comparator | Inert placebo pill prior to an oral glucose tolerance test Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose incremental area under the curve
glucose incremental area under the curve measured during an oral glucose tolerance test
Measured: 2 hours
Secondary outcomes (8)
Mean glucose concentration
Mean glucose concentration measured during an oral glucose tolerance test
Measured: 2 hours
Insulin incremental area under the curve
insulin incremental area under the curve measured during an oral glucose tolerance test
Measured: 2 hours
Mean insulin concentration
mean insulin concentration measured during an oral glucose tolerance test
Measured: 2 hours
peak glucose concentration
peak glucose concentration measured during an oral glucose tolerance test
Measured: 2 hours
peak insulin concentration
peak insulin concentration measured during an oral glucose tolerance test
Measured: 2 hours
Postprandial glucose oxidation
Postprandial glucose oxidation measured with a metabolic tracer
Measured: 2 hours
Appetite perceptions
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.
Measured: 2 hours
Insulin sensitivity
insulin sensitivity measured via the Matsuda Index during an oral glucose tolerance test
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start8 Feb 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Responsible party
- Principal investigator, Jenna Gillen, University of Toronto
- Investigators
- Jenna Gillen, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121713
- Sponsor's protocol ID
- 44741
- Acronym
- GCE
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Green Coffee Extract Combined With Alpha-Lipoic Acid on Blood Glucose Homeostasis in Healthy Adults
- ClinicalTrials.gov ID
- NCT06121713
- Acronym / sponsor ID
- GCE / 44741
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GCE + Low ALA | Active comparator | Dietary Supplement: GCE + Low ALAGreen coffee extract and a low dose of alpha-lipoic acid prior to an oral glucose tolerance test |
| GCE + High ALA | Active comparator | Dietary Supplement: GCE + High ALAGreen coffee extract and a moderate dose of alpha-lipoic acid prior to an oral glucose tolerance test |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInert placebo pill prior to an oral glucose tolerance test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCE + Low ALAParticipants will consume a pill containing 200mg green coffee extract and 200mg alpha-lipoic acid 30 minutes before a 75g oral glucose tolerance test | Dietary supplement | GCE + Low ALA |
| GCE + High ALAParticipants will consume a pill containing 200mg green coffee extract and 400mg alpha-lipoic acid 30 minutes before a 75g oral glucose tolerance test | Dietary supplement | GCE + High ALA |
| PlaceboParticipants will consume a placebo pill (500mg insoluble microcrystalline cellulose, 5mg magnesium stearate, 5mg silicon dioxide) prior to a 75g oral glucose tolerance test | Dietary supplement | Placebo |
Primary outcome
Glucose incremental area under the curve
Time frame: 2 hours
glucose incremental area under the curve measured during an oral glucose tolerance test
8 secondary outcomes
Mean glucose concentration
Time frame: 2 hours
Insulin incremental area under the curve
Time frame: 2 hours
Mean insulin concentration
Time frame: 2 hours
peak glucose concentration
Time frame: 2 hours
peak insulin concentration
Time frame: 2 hours
Postprandial glucose oxidation
Time frame: 2 hours
Appetite perceptions
Time frame: 2 hours
Insulin sensitivity
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna Gillen, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GCE + Low ALA and GCE + High ALA in people with Nutrition, Healthy, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose incremental area under the curve (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.