850 PBC
Phoenix, Arizona, 85004, United States
NCT Number: NCT05698381
The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.
Looking for future studies?
Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
Recent research, in animal and human subjects, suggests that vinegar intake is inversely associated with insulin resistance, mood states and depression, inflammation, and other disease parameters. The study will be conducted as a randomized controlled trial in overweight adults to further examine these relationships and possible mechanisms. Although the mechanisms are not known, research suggests that changes in the gut microbiome, a response to the ingestion of the postbiotic acetic acid, may factor into the beneficial effects of vinegar ingestion. Through analyses of blood, changes in key blood metabolites associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health (e.g., LPS binding protein) and inflammation (e.g., CRP) will be assessed. Additionally mood state will be assessed using validated measures and determine risk for metabolic syndrome, a cluster of risk factors associated with many chronic conditions. It is hypothesized that vinegar ingestion will promote beneficial changes to these health parameters.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 tablespoons consumed twice daily with meals
2 pills consumed upon waking
Time frame: change from baseline at week 4
Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)
Time frame: change from baseline at week 4
Center for Epidemiologic Studies Depression Scale (CES-D); scores range from 0 to 60 (higher scores suggest a greater presence of depressive symptoms. A score of 15 or higher is interpreted to indicate a risk for depression).
Time frame: change from baseline at week 4
Blood levels of the neurotransmitter GABA
Time frame: change from baseline at week 4
A cluster of conditions that increase risk of heart disease, stroke and type 2 diabetes: increased blood pressure, high blood sugar, waist circumference, and abnormal cholesterol or triglyceride levels. siMS score = 2*Waist/Height + Gly/5.6 + Tg/1.7 + TAsystolic/130-HDL/1.02 or 1.28 (for male or female subjects, respectively) (adapted from Soldatovic et al. (2016) siMS Score: Simple Method for Quantifying Metabolic Syndrome. PLoS ONE 11(1): e014614)
Time frame: change from baseline at week 4
Blood C-reactive protein
Time frame: change from baseline at week 4
Blood Lipopolysaccharide binding protein
Arizona State University
Other
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State, Inflammatory State, and Risk for Metabolic Syndrome in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03794531
Behavior, Behavior, Animal
San Juan, Puerto Rico
View Trial DetailsNCT06186102
Arterial Occlusive Diseases, Arteriosclerosis
Aarhus, Jutland, Denmark
View Trial DetailsNCT06055322
Alzheimer Disease, Behavior
Lubbock, Texas, United States
View Trial DetailsNCT03973996
Bacteremia, Dysbiosis
Columbus, Ohio, United States
View Trial Details