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

Healthy Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181214
• Other study ID #: AG-01-0623
• Status: Completed
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: October 4, 2023

Study information

• Verified date: March 2024
• Source: Athletic Greens International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 4, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 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 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.

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Healthy Aging

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Athletic Greens International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete Metabolic Blood Panel	Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine	28 Days
Secondary	Complete Blood Count	Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit	28 Days
Secondary	Exploratory nutrient status markers	Circulating concentrations of nutrient status (e.gg, zinc, vitamin c, folate, & magnesium)	28 days
Secondary	Exploratory Digestive Measures	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	28 days
Secondary	Exploratory Stool Consistency	Bristol Stool Scale (score 1-7) questionnaire that allows participants to identify how loose or hard their stool consistency is	28 days
Secondary	Exploratory Stool Frequency	100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements	28 days