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

NCT06181214 | Completed

• 1 other identifier: AG-01-0623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Microbiome; Nutrition, Healthy; Healthy Aging

Outcome Measures

Primary Outcomes (1)

• Gut Microbiome

  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.

  28 days

Secondary Outcomes (6)

• Complete Metabolic Blood Panel

  28 Days

• Complete Blood Count

  28 Days

• Exploratory nutrient status markers

  28 days

• Exploratory Digestive Measures

  28 days

• Exploratory Stool Consistency

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin + Flavoring

Dietary Supplement: Placebo

AG1 - Nutritional Supplement

EXPERIMENTAL

A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

Dietary Supplement: AG1 - Nutritional Supplement

Interventions

AG1 - Nutritional Supplement DIETARY_SUPPLEMENT

A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

AG1 - Nutritional Supplement

Placebo DIETARY_SUPPLEMENT

Maltodextrin placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athletic Greens International: lead

Study Sites (1)

Center for Applied Health Sciences

Canfield, Ohio, 44046, United States

Location

Related Publications (1)

• La Monica MB, Raub B, Hartshorn S, Gustat AL, Grdic J, Kirby TO, Townsend JR, Sandrock J, Ziegenfuss TN. The effects of AG1(R) supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial. J Int Soc Sports Nutr. 2024 Dec;21(1):2409682. doi: 10.1080/15502783.2024.2409682. Epub 2024 Oct 1.

  PMID: 39352252 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo Controlled Design

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 26, 2023
• Study Start: August 14, 2023
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

US (1)