Ketones Supplementation and Postprandial Lipemia

NCT ID: NCT03729934

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-01-01

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.

Conditions

Obesity; Overweight and Obesity; Overweight; Triglycerides High

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

This arm receives no treatment control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ketone Ester

This arm receives 25 g ketone ester.

Group Type: EXPERIMENTAL

Ketone Ester

Intervention Type: DIETARY_SUPPLEMENT

This arm receives 25 g ketone ester.

Ketone Salt

This arm receives 25 g ketone salt.

Group Type: EXPERIMENTAL

Ketone Salt

Intervention Type: DIETARY_SUPPLEMENT

This arm receives 25 g ketone salt.

Interventions

Ketone Ester

This arm receives 25 g ketone ester.

Intervention Type: DIETARY_SUPPLEMENT

Ketone Salt

This arm receives 25 g ketone salt.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Eric P. Plaisance

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KBS2018

Identifier Type: -

Identifier Source: org_study_id