Clinical trial NCT06106620: Effects of a Multi-Ingredient Dietary Supplement on Blood and Breath Alcohol Levels
Official title: Effects of a Multi-Ingredient Dietary Supplement Consisting of Vitamins, Minerals, Botanicals, and Nootropics on Blood and Breath Alcohol Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol.

Detailed description: This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease.

Participants will attend three study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, and background baseline diet. During Visits 2 and 3 participants will ingest 100 mL (3.4 oz) of 40% alcohol, along with a commercially available liquid blend of dietary supplements or a placebo, and undergo assessments of breath alcohol content, blood alcohol levels, blood alcohol dehydrogenase levels, and various visual analog scales (VAS) for indices of affect (headache, nausea, fatigue, energy, tiredness, thirst, concentration) for 4 hours post-ingestion. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.

Eligibility criteria: Inclusion Criteria:

* Provide voluntary signed and dated informed consent.
* Be in good health as determined by medical history and routine blood chemistries.
* Age between the ages of 21 and 55 (inclusive).
* Body Mass Index of 18.5-34.9 (inclusive).
* Body weight of at least 110 pounds.
* Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
* Normal seated, resting heart rate (\<90 per minute).
* Willing to duplicate their previous 24-hour diet, refrain from alcohol for 48 hours, caffeine and exercise for 24 hours prior to each trial, and fast for 10 hours prior each of the treatments.
* Agreeable to have a third-party transport home following interventional visits.
* Able to provide an adequate blood draw.
* Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
* Subject is willing and able to comply with the study protocol.

Exclusion Criteria:

* History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
* Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or history of drug/alcohol abuse or dependence.
* History of diabetes or endocrine disorder.
* Fasting blood sugar of \> 125 mg/dL.
* Current smokers or cessation of smoking within the past month.
* History of hyperparathyroidism or an untreated thyroid disease.
* History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
* Prior gastrointestinal bypass surgery (Lapband), etc., known gastrointestinal disorder that may impact nutrient absorption e.g., short bowel syndrome, atrophic gastritis, IBD, diarrheal illnesses, history of colon resection, gastro-paresis, celiac disease, Inborn-Errors-of-Metabolism (such as PKU).
* Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's Disease, ulcerative colitis, lupus, HIV/AIDS, etc.).
* Previous medical diagnosis of asthma, gout, or fibromyalgia.
* Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
* Known sensitivity to any ingredient in the test formulations as listed in the product label.
* Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Primary outcomes:
measure: Headache
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Nausea
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Fatigue
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Energy
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Tiredness
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Thirst
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Concentration
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary outcomes:
measure: Breath alcohol level
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Blood alcohol level
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Blood alcohol dehydrogenase level
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Blood acetaldehyde level
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Blood aldehyde dehydrogenase level
timeFrame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Urine volume
timeFrame: Change from baseline to 60 minutes, 120 minutes, 180 minutes, and 240 minutes.
Other outcomes:
measure: Systolic blood pressure
timeFrame: Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Diastolic blood pressure
timeFrame: Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.
measure: Heart rate
timeFrame: Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
References: