Ketones Supplementation and Postprandial Lipemia

• ClinicalTrials.gov Identifier: NCT03729934
• Recruitment Status: Withdrawn
• First Posted: November 5, 2018
• Last Update Posted: May 4, 2021
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Eric P. Plaisance, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Overweight and Obesity; Overweight; Triglycerides High	Dietary Supplement: Ketone Ester; Dietary Supplement: Ketone Salt	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Effects of Ketones Supplementation on Postprandial Lipemia
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: January 1, 2021
• Actual Study Completion Date: January 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline plasma glucagon-like peptide 1 at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Plasma levels of glucagon-like peptide 1 in pg/L
2. Change from baseline serum triglycerides at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Serum levels of triglycerides in mg/DL
3. Change from baseline serum glucose at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Serum levels of glucose in mg/dL
4. Change from baseline serum Insulin at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Serum levels of insulin in pmol/L
5. Change from baseline serum B-hydroxybutyrate at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Serum levels of B-hydroxybutyrate in mmol/L
6. Change from baseline plasma ghrelin at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Plasma levels of ghrelin in pg/mL
7. Change from baseline plasma leptin at 240 minutes [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption ]
   Plasma levels of leptin in ng/mL

Eligibility Criteria

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Eric P. Plaisance, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03729934
• Other Study ID Numbers: KBS2018
• First Posted: November 5, 2018
• Last Update Posted: May 4, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight