NCT06121713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

November 2, 2023

Last Update Submit

July 24, 2024

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (1)

  • Glucose incremental area under the curve

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

    2 hours

Secondary Outcomes (8)

  • Mean glucose concentration

    2 hours

  • Insulin incremental area under the curve

    2 hours

  • Mean insulin concentration

    2 hours

  • peak glucose concentration

    2 hours

  • peak insulin concentration

    2 hours

  • +3 more secondary outcomes

Study Arms (3)

GCE + Low ALA

ACTIVE COMPARATOR

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

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

Dietary Supplement: GCE + High ALA

Placebo

PLACEBO COMPARATOR

Inert placebo pill prior to an oral glucose tolerance test

Dietary Supplement: Placebo

Interventions

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 + Low ALA
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

GCE + High ALA
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

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • BMI 20 - 30 kg/m2
  • Weight stable (within ± 2kg for at least 6 months)
  • Experiencing monthly menstrual periods (eumenorrheic) if female
  • Non-smoker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M4K1C8, Canada

Location

Study Officials

  • Jenna Gillen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

February 8, 2024

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)