Ketones Supplementation and Postprandial Lipemia

NCT03729934 | Withdrawn

• 1 other identifier: KBS2018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Overweight and Obesity; Overweight; Triglycerides High

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Control

NO INTERVENTION

This arm receives no treatment control.

Ketone Ester

EXPERIMENTAL

This arm receives 25 g ketone ester.

Dietary Supplement: Ketone Ester

Ketone Salt

EXPERIMENTAL

This arm receives 25 g ketone salt.

Dietary Supplement: Ketone Salt

Interventions

Ketone Ester DIETARY_SUPPLEMENT

This arm receives 25 g ketone ester.

Ketone Ester

Ketone Salt DIETARY_SUPPLEMENT

This arm receives 25 g ketone salt.

Ketone Salt

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Obesity; Overweight; Hypertriglyceridemia

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 5, 2018
• Study Start: December 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-04