Ketones Supplementation and Postprandial Lipemia

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Overweight; Overweight and Obesity; Triglycerides High; Obesity

Treatments: Dietary Supplement: Ketone Ester; Dietary Supplement: Ketone Salt

Study type: Interventional

Funder types: Other

Identifiers

NCT03729934

KBS2018

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 25 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Control

No Intervention group

Description:

This arm receives no treatment control.

Ketone Ester

Experimental group

Description:

This arm receives 25 g ketone ester.

Treatment:

Dietary Supplement: Ketone Ester

Ketone Salt

Experimental group

Description:

This arm receives 25 g ketone salt.

Treatment:

Dietary Supplement: Ketone Salt