The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health

• ClinicalTrials.gov Identifier: NCT06181214
• Recruitment Status: Completed
• First Posted: December 26, 2023
• Last Update Posted: March 22, 2024
• Sponsor: Athletic Greens International
• Information provided by (Responsible Party): Athletic Greens International

Tracking Information

• First Submitted Date: December 5, 2023
• First Posted Date: December 26, 2023
• Last Update Posted Date: March 22, 2024
• Actual Study Start Date: August 14, 2023
• Actual Primary Completion Date: October 4, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 21, 2024)

Gut Microbiome [ Time Frame: 28 days ]

Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.

Original Primary Outcome Measures (submitted: December 12, 2023)

• Gut Microbiome [ Time Frame: 28 days ]
  Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.
• Digestive Measures [ Time Frame: 28 days ]
  A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life
• Stool Consistency [ Time Frame: 28 days ]
  Bristol Stool Scale (score 1-7) questionnaire that allows participants to identify how loose or hard their stool consistency is
• Stool Frequency [ Time Frame: 28 days ]
  100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements

Current Secondary Outcome Measures (submitted: February 21, 2024)

• Complete Metabolic Blood Panel [ Time Frame: 28 Days ]
  Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine
• Complete Blood Count [ Time Frame: 28 Days ]
  Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
• Exploratory nutrient status markers [ Time Frame: 28 days ]
  Circulating concentrations of nutrient status (e.gg, zinc, vitamin c, folate, & magnesium)
• Exploratory Digestive Measures [ Time Frame: 28 days ]
  A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life
• Exploratory Stool Consistency [ Time Frame: 28 days ]
  Bristol Stool Scale (score 1-7) questionnaire that allows participants to identify how loose or hard their stool consistency is
• Exploratory Stool Frequency [ Time Frame: 28 days ]
  100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements

Original Secondary Outcome Measures (submitted: December 12, 2023)

• Complete Metabolic Blood Panel [ Time Frame: 28 Days ]
  Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine
• Complete Blood Count [ Time Frame: 28 Days ]
  Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
• Exploratory nutrient status markers [ Time Frame: 28 days ]
  Circulating concentrations of nutrient status (e.gg, zinc, vitamin c, folate, & magnesium)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
• Official Title: The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
• Brief Summary: This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, Double-Blind, Placebo Controlled Design

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other

Condition

• Gastrointestinal Microbiome
• Nutrition, Healthy
• Healthy Aging

Intervention

• Dietary Supplement: AG1 - Nutritional Supplement
  A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
• Dietary Supplement: Placebo
  Maltodextrin placebo

Study Arms

• Placebo Comparator: Placebo
  Maltodextrin + Flavoring
  Intervention: Dietary Supplement: Placebo
• Experimental: AG1 - Nutritional Supplement
  A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
  Intervention: Dietary Supplement: AG1 - Nutritional Supplement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 12, 2023): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 4, 2023
• Actual Primary Completion Date: October 4, 2023 (Final data collection date for primary outcome measure)

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 18 and 50 yr (inclusive).
• Body Mass Index of 18.5-29.9 (inclusive).
• Body weight of at least 120 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 caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit.
• 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 conditions.
• History of diabetes or endocrine disorder.
• History of use of medications or dietary supplements known to confound the study or its endpoints.
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
• Current smokers or smoking within the past month.
• History of hyperparathyroidism or an untreated thyroid condition.
• 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.
• Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, Irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, 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.
• Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
• Any other 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06181214
• Other Study ID Numbers: AG-01-0623
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Athletic Greens International
• Original Responsible Party: Same as current
• Current Study Sponsor: Athletic Greens International
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Athletic Greens International
• Verification Date: March 2024