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Withdrawn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
About this trial
This is an interventional prevention trial for Obesity
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
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
NCT ID
NCT03729934
First Posted
October 23, 2018
Last Updated
April 29, 2021
Sponsor
University of Alabama at Birmingham
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Withdrawn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
Learn more about this trial
Ketones Supplementation and Postprandial Lipemia
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