Ketones Supplementation and Postprandial Lipemia

Effects of Ketones Supplementation on Postprandial Lipemia

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Overweight; Overweight and Obesity; Triglycerides High
• Intervention / Treatment: Dietary supplement: Ketone Ester; Dietary supplement: Ketone Salt

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This arm receives no treatment control.
Experimental: Ketone Ester; This arm receives 25 g ketone ester.	Dietary supplement: Ketone Ester; This arm receives 25 g ketone ester.
Experimental: Ketone Salt; This arm receives 25 g ketone salt.	Dietary supplement: Ketone Salt; This arm receives 25 g ketone salt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline plasma glucagon-like peptide 1 at 240 minutes	Plasma levels of glucagon-like peptide 1 in pg/L	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum triglycerides at 240 minutes	Serum levels of triglycerides in mg/DL	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum glucose at 240 minutes	Serum levels of glucose in mg/dL	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum Insulin at 240 minutes	Serum levels of insulin in pmol/L	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum B-hydroxybutyrate at 240 minutes	Serum levels of B-hydroxybutyrate in mmol/L	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline plasma ghrelin at 240 minutes	Plasma levels of ghrelin in pg/mL	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline plasma leptin at 240 minutes	Plasma levels of leptin in ng/mL	0, 30, 60, 120, 180, and 240 minutes post-supplement consumption

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: KBS2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No