Effects of a Multi-Ingredient Dietary Supplement on Blood and Breath Alcohol Levels

Alcohol Drinking Clinical Trial

Official title:

Effects of a Multi-Ingredient Dietary Supplement Consisting of Vitamins, Minerals, Botanicals, and Nootropics on Blood and Breath Alcohol Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106620
• Other study ID #: SS-1023-001
• Status: Completed
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: May 2024
• Source: The Center for Applied Health Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Dietary Supplement:
• Placebo
Placebo drink consisting of 12 oz of flavor-matched water.
• Safety Shot
Safety Shot consisting of a 12 oz drink containing vitamins, mineral, and botanical extracts.

Locations

Country	Name	City	State
United States	The Center for Applied Health Sciences	Canfield	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Center for Applied Health Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic blood pressure	Systolic blood pressure in mm of mercury.	Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Other	Diastolic blood pressure	Diastolic blood pressure in mm of mercury.	Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Other	Heart rate	Heart rate in beats per minute.	Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Headache	Headache as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent a greater headache.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Nausea	Nausea as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater nausea.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Fatigue	Fatigue as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater fatigue.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Energy	Energy as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater energy.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Tiredness	Tiredness as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater tiredness.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Thirst	Thirst as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater thirst.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Primary	Concentration	Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater concentration.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary	Breath alcohol level	Breath alcohol level measured in %.	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary	Blood alcohol level	Blood alcohol level measured in milligrams per deciliter (mg/dL).	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary	Blood alcohol dehydrogenase level	Blood alcohol dehydrogenase level measured picograms per milliliter (pg/mL).	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary	Blood acetaldehyde level	Blood acetaldehyde level as measured in milligrams per deciliter (mg/dL).	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary	Blood aldehyde dehydrogenase level	Blood aldehyde dehydrogenase level as measured in nanograms per milliliter (ng/mL).	Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary	Urine volume	Urine volume as measured in milliliters.	Change from baseline to 60 minutes, 120 minutes, 180 minutes, and 240 minutes.