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

NCT06106620 | Completed DMC

• 1 other identifier: SS-1023-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (6)

• Breath alcohol level

  Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

• Blood alcohol level

  Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

• Blood alcohol dehydrogenase level

  Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

• Blood acetaldehyde level

  Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

• Blood aldehyde dehydrogenase level

  Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.

Other Outcomes (3)

• Systolic blood pressure

  Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.

• Diastolic blood pressure

  Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.

• Heart rate

  Change from baseline to 60 minutes, 120 minutes, 180 minutes and 240 minutes.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

12 oz of flavor-matched water.

Dietary Supplement: Placebo

Safety Shot

EXPERIMENTAL

12 oz of Safety Shot containing a blend of vitamins, minerals and botanical extracts.

Dietary Supplement: Safety Shot

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo drink consisting of 12 oz of flavor-matched water.

Placebo

Safety Shot DIETARY_SUPPLEMENT

Safety Shot consisting of a 12 oz drink containing vitamins, mineral, and botanical extracts.

Safety Shot

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: December 30, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)