Obesity Clinical Trial
Official title:
Effects of Ketones Supplementation on Postprandial Lipemia
Verified date | April 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
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 |
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