The Effect of Green Coffee Extract on Blood Glucose Homeostasis in Healthy Adults
NCT ID: NCT06137066
Last Updated: 2024-05-10
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-12-01
2024-05-08
Brief Summary
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Detailed Description
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Alpha-lipoic acid (ALA) is a cofactor of mitochondrial dehydrogenase complexes and a potent antioxidant that has been implicated in glucose metabolism. ALA increases the translocation of glucose transporter type 4 to cell membranes and improves insulin sensitivity through adenosine monophosphate-activated protein kinase (AMPK) activation, both of which facilitate glucose uptake. Furthermore, 300mg of ALA has been shown to improve endothelial function and reduce fasted blood glucose concentrations in clinical populations. Therefore, investigating the effects of a lower ALA dosage, specifically 200mg, compared to 400mg in the acute fed state, as well as whether ALA and GCE can act synergistically to elicit favourable effects on postprandial glucose control requires further investigation in healthy adults.
Berberine, a known AMPK activator, is a natural alkaloid present in various parts (root, stem, fruit, bark) of multiple plants including, in particular, species found in the Coptis, Hydrastis, and Berberis genus. Chronic berberine supplementation (lasting 1 month) resulted in reduced fasting blood glucose, 2-hour postprandial blood glucose levels, and insulin resistance index scores, outperforming standard care alone in individuals with metabolic syndrome, suggesting that berberine may assist with blood glucose regulation in this population. Berberine has low bioavailability (\<1%) reported in both animal and human models largely due to poor intestinal absorption and high levels of first-pass removal in the intestines and liver. To overcome this limitation, higher doses of berberine (500-1500mg) are commonly administered, which may lead to gastrointestinal adverse events. Dihydroberberine (DHB), a highly bioavailable form of berberine, has been shown to achieve greater area under the curve as well as peak berberine concentrations when compared to oral ingestion of 500 mg berberine or placebo in humans. However, whether acute DHB supplementation in combination with green coffee extract elicits beneficial effects on postprandial glucose handling in healthy adults has yet to be elucidated.
The purpose of the current study is to determine the impact of acute supplementation of GCE on postprandial glycemia in healthy adults. A secondary objective is to evaluate the effect of GCE on postprandial insulinemia, insulin sensitivity, glucose oxidation and appetite perceptions. The investigators hypothesize that compared to placebo, a 200mg dose of GCE combined with 400 mg alpha-lipoic acid consumed 30 min prior to a 75g oral glucose challenge will 1) lower 2-hour glucose incremental area under the curve (AUC; primary outcome); 2) lower 2-hour insulin incremental AUC and insulin resistance (Matsuda Index); 3) increase rates of glucose oxidation; and 4) lower appetite perceptions. The investigators also hypothesize that the 200 mg dose of GCE combined with 400 mg alpha-lipoic acid will exert effects like, or greater than, the 200 mg dose of GCE with 200 mg of DHB.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo
Placebo supplement consisting of microcrystalline cellulose with 5mg magnesium stearate and 5mg silicon dioxide.
Placebo
microcrystalline cellulose with 5 mg magnesium stearate and 5 mg silicon dioxide
200mg GCE +200mg ALA
200mg green coffee extract +200mg alpha-lipoic acid
200mg GCE +200mg ALA
200mg green coffee extract + 200mg alpha-lipoic acid
200mg GCE +400mg ALA
200mg green coffee extract +200mg alpha-lipoic acid
200mg GCE +400mg ALA
200mg green coffee extract + 400mg alpha-lipoic acid
200mg GCE +200mg DHB
200mg green coffee extract + 200mg dihydroberberine
200mg GCE + 200mg DHB
200mg green coffee extract + 200mg dihydroberberine
Interventions
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200mg GCE +200mg ALA
200mg green coffee extract + 200mg alpha-lipoic acid
200mg GCE +400mg ALA
200mg green coffee extract + 400mg alpha-lipoic acid
200mg GCE + 200mg DHB
200mg green coffee extract + 200mg dihydroberberine
Placebo
microcrystalline cellulose with 5 mg magnesium stearate and 5 mg silicon dioxide
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.)
18 Years
45 Years
ALL
Yes
Sponsors
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Iovate Health Sciences International Inc
INDUSTRY
Dr. Chris McGlory, PhD
OTHER
Responsible Party
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Dr. Chris McGlory, PhD
Assistant Professor
Principal Investigators
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Chris McGlory
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Queen's University
Kingston, Ontario, Canada
Countries
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Other Identifiers
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6039146
Identifier Type: -
Identifier Source: org_study_id
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