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Ketones Supplementation and Postprandial Lipemia

Primary Purpose

Obesity, Overweight and Obesity, Overweight

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketone Ester
Ketone Salt
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight or obese men as defined by a BMI of greater than or equal to 25 kg/m2, but less than 35 kg/m2
  • Between the ages of 25 and 45 years
  • Fasting triglyceride levels less than 250 mg/dL

Exclusion Criteria:

  • Participates in regular physical activity (≥3 days/week at 30 minutes or more per day)
  • Diagnosed cardiovascular disease or metabolic disease (type 1 or type 2 diabetes)
  • Currently following a low carbohydrate (<100 g/day) diet
  • Lost greater than or equal to 5% body weight over the last 2 months
  • Alcohol/smoking/antibiotics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control

    Ketone Ester

    Ketone Salt

    Arm Description

    This arm receives no treatment control.

    This arm receives 25 g ketone ester.

    This arm receives 25 g ketone salt.

    Outcomes

    Primary Outcome Measures

    Change from baseline plasma glucagon-like peptide 1 at 240 minutes
    Plasma levels of glucagon-like peptide 1 in pg/L
    Change from baseline serum triglycerides at 240 minutes
    Serum levels of triglycerides in mg/DL
    Change from baseline serum glucose at 240 minutes
    Serum levels of glucose in mg/dL
    Change from baseline serum Insulin at 240 minutes
    Serum levels of insulin in pmol/L
    Change from baseline serum B-hydroxybutyrate at 240 minutes
    Serum levels of B-hydroxybutyrate in mmol/L
    Change from baseline plasma ghrelin at 240 minutes
    Plasma levels of ghrelin in pg/mL
    Change from baseline plasma leptin at 240 minutes
    Plasma levels of leptin in ng/mL

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2018
    Last Updated
    April 29, 2021
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03729934
    Brief Title
    Ketones Supplementation and Postprandial Lipemia
    Official Title
    Effects of Ketones Supplementation on Postprandial Lipemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Dissertation for student changed.
    Study Start Date
    December 1, 2020 (Actual)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit.
    Detailed Description
    Previous studies conducted by the investigative team in rodents show that male mice fed a diet containing 30% ketone ester (by kcals) results in greater fecal content and energy loss. While the investigators are unsure of the exact macronutrient content of the energy loss, the hypothesis is that the energy excretion is attributed to lower fat absorption. In the context of this study, it's hypothesized that ketone salts and ketone esters (both available commercially and used for a variety of health-related claims) will reduce the absorption of dietary fats leading to lower circulating triglyceride concentrations if consumed prior to a high-fat mixed meal. If the hypothesis is correct, ketones supplementation could become a valuable strategy to reduce the rise in circulating triglycerides often present in obesity. Triglyceride concentrations in the blood following a meal have been linked to development of cardiovascular disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Overweight and Obesity, Overweight, Triglycerides High

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    This arm receives no treatment control.
    Arm Title
    Ketone Ester
    Arm Type
    Experimental
    Arm Description
    This arm receives 25 g ketone ester.
    Arm Title
    Ketone Salt
    Arm Type
    Experimental
    Arm Description
    This arm receives 25 g ketone salt.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ketone Ester
    Intervention Description
    This arm receives 25 g ketone ester.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ketone Salt
    Intervention Description
    This arm receives 25 g ketone salt.
    Primary Outcome Measure Information:
    Title
    Change from baseline plasma glucagon-like peptide 1 at 240 minutes
    Description
    Plasma levels of glucagon-like peptide 1 in pg/L
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
    Title
    Change from baseline serum triglycerides at 240 minutes
    Description
    Serum levels of triglycerides in mg/DL
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
    Title
    Change from baseline serum glucose at 240 minutes
    Description
    Serum levels of glucose in mg/dL
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
    Title
    Change from baseline serum Insulin at 240 minutes
    Description
    Serum levels of insulin in pmol/L
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
    Title
    Change from baseline serum B-hydroxybutyrate at 240 minutes
    Description
    Serum levels of B-hydroxybutyrate in mmol/L
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
    Title
    Change from baseline plasma ghrelin at 240 minutes
    Description
    Plasma levels of ghrelin in pg/mL
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
    Title
    Change from baseline plasma leptin at 240 minutes
    Description
    Plasma levels of leptin in ng/mL
    Time Frame
    0, 30, 60, 120, 180, and 240 minutes post-supplement consumption

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Overweight or obese men as defined by a BMI of greater than or equal to 25 kg/m2, but less than 35 kg/m2 Between the ages of 25 and 45 years Fasting triglyceride levels less than 250 mg/dL Exclusion Criteria: Participates in regular physical activity (≥3 days/week at 30 minutes or more per day) Diagnosed cardiovascular disease or metabolic disease (type 1 or type 2 diabetes) Currently following a low carbohydrate (<100 g/day) diet Lost greater than or equal to 5% body weight over the last 2 months Alcohol/smoking/antibiotics

    12. IPD Sharing Statement

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    Ketones Supplementation and Postprandial Lipemia

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