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Trial record 71 of 7493 for:    Area Under Curve

Exogenous Ketones and Glucose Tolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461068
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Brief Summary:
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to an oral glucose tolerance test in individuals with impaired fasting glucose.

Condition or disease Intervention/treatment Phase
Ketones Dietary Supplements Dietary Supplement: Ketone monoester Dietary Supplement: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Placebo masked with flavouring and participants consume in opaque containers
Primary Purpose: Basic Science
Official Title: The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketone monoester
Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)
Dietary Supplement: Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.

Placebo Comparator: Placebo
Acute morning dose of flavour-matched placebo.
Dietary Supplement: Placebo
Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.




Primary Outcome Measures :
  1. Glucose area under the curve [ Time Frame: 2-hour ]
    Area under the curve for glucose during oral glucose tolerance test


Secondary Outcome Measures :
  1. Insulin area under the curve [ Time Frame: 2-hour ]
    Insulin area under the curve during oral glucose tolerance test

  2. Free fatty acids area under the curve [ Time Frame: 2-hour ]
    Non-esterified fatty acids area under the curve during oral glucose tolerance test

  3. Caspase-1 activation [ Time Frame: 15 minutes ]
    Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning

  4. Inflammatory cytokines [ Time Frame: 15 minutes ]
    Inflammatory cytokines assessed before and after ketone or placebo ingestion in the morning

  5. C-peptide area under the curve [ Time Frame: 2-hour ]
    C-peptide area under the curve during oral glucose tolerance test

  6. GLP-1 area under the curve [ Time Frame: 2-hour ]
    GLP-1 area under the curve during oral glucose tolerance test

  7. Glucagon area under the curve [ Time Frame: 2-hour ]
    Glucagon area under the curve during oral glucose tolerance test

  8. Glucose incremental area under the curve [ Time Frame: 2-hour ]
    Incremental area under the curve (above baseline) for glucose during oral glucose tolerance test

  9. Insulin incremental area under the curve [ Time Frame: 2-hour ]
    Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test

  10. 2-hr glucose level [ Time Frame: 2-hour ]
    Plasma glucose assessed 2-hr after oral glucose tolerance test.

  11. Oral glucose sensitivity index [ Time Frame: 2-hour ]
    Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not taking any medications affecting glucose metabolism.
  • Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index >28 kg/m2 OR elevated waist circumference (>102 cm for males, >88 cm for females)

Exclusion Criteria:

  • Diagnosed with diabetes.
  • Diagnosed with heart disease.
  • Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
  • Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
  • Current consumption of ketone supplements
  • Pregnant or planning to become pregnant during the study (if female)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461068


Locations
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Canada, British Columbia
University of British Columbia, Okanagan.
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03461068     History of Changes
Other Study ID Numbers: H16-01846
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No