Effects of Exogenous Ketones in Healthy Young Adults

Study Overview
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Brief Summary
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Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.

Detailed Description
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A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.

Official Title
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Effects of Exogenous Ketones in Healthy Young Adults

Conditions
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Healthy Young Adults

Intervention / Treatment
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* Dietary Supplement: Ketone Salts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy (no known conditions) Exclusion Criteria: Chronic smoker Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blinded, 2-groups (condition and placebo)
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Ketone Salts|Subjects will take 2 servings of ketone salts daily for 6 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood health parameters | Comprehensive Metabolic Panel | 6 weeks on the supplement | 
| Blood health parameter | Complete blood count | 6 weeks on the supplement | 
| Blood health parameter | Lipid Panel | 6 weeks on the supplement | 
| Blood health parameter | Insulin | 6 weeks on the supplement | 
| Blood ketone levels | Blood ketones assessed 30- and 60 minutes after consuming the supplement | Baseline and 6 weeks after chronic consumption | 
| Cardiovascular | Blood Pressure | 6 weeks on the supplement | 
| Body Composition | Skinfold measure | 6 weeks on the supplement | 
| Body Composition | Weight | 6 weeks on the supplement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exogenous ketone salts, ketosis, safety, comprehensive metabolic panel, complete blood count, lipid panel, insulin