Ketones Supplementation and Postprandial Lipemia

Obesity Clinical Trial

Official title:

Effects of Ketones Supplementation on Postprandial Lipemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03729934
• Other study ID #: KBS2018
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Triglycerides High

Intervention

Dietary Supplement:
• Ketone Ester
This arm receives 25 g ketone ester.
• Ketone Salt
This arm receives 25 g ketone salt.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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