Effects of Ketones Supplementation on Postprandial Lipemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Change from baseline serum triglycerides at 240 minutes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
This arm receives no treatment control.
Ketone Ester
This arm receives 25 g ketone ester.
Intervention: Ketone Ester (Dietary Supplement)
Ketone Salt
This arm receives 25 g ketone salt.
Intervention: Ketone Salt (Dietary Supplement)
Outcomes
Primary Outcomes
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
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
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
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
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
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Eric P. Plaisance
Associate Professor
University of Alabama at Birmingham