The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life

Healthy Aging Clinical Trial

Official title:

The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332898
• Other study ID #: AG-01-0324
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: February 4, 2025

Study information

• Verified date: March 2024
• Source: Athletic Greens International
• Contact: Ellen O'Gorman
• Phone: (805) 292-0714.
• Email: ellen[@]citruslabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 4, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Provide voluntary signed and dated informed consent.

• No known history of chronic illness or disease.

• Aged between 18 and 59.9 years (inclusive).

• Body Mass Index of 20-34.9 (inclusive).

• Willing to duplicate their previous 24-hour diet, refrain from caffeine and exercise for 24 hours, and fast for 10 hours prior to each Quest visit.

• Agree to maintain existing dietary and physical activity patterns throughout the study period.

• Willing and able to comply with the study protocol.

Exclusion Criteria:

• History of unstable or new-onset cardiovascular, liver, or renal conditions.

• History of diabetes or endocrine disorder.

• Multivitamin/Multimineral supplement consumption within the past 3 months.

• Regular consumption (i.e., at least five days/week) of resveratrol, quercetin, pterostilbene, coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber, green tea, niacin (vitamin B3), or products meant to promote "healthy aging" or "anti-aging" or "longevity" in the 2 months prior to screening as well as throughout the study.

• Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 90 days prior to study.

• History of use of medications or dietary supplements known to confound the study or its endpoints.

• Excessive 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, IBS/IBD, diarrheal illnesses, history of colon resection, gastroparesis, 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 conceive, women less than 120 days postpartum, or nursing women.

• A change in hormone therapy, including oral contraceptives, within 4 weeks prior to screening, or unwilling to maintain current hormone therapy/oral contraceptive use throughout the course of the study.

• Known allergy or 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.

>10% weight change in the last 6 months.

• Specific exclusion type diets like vegan, vegetarian, carnivore, paleo, atkins, ketogenic etc.

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
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Athletic Greens International	Citruslabs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homocysteine	Circulating Serum Homocysteine Concentrations (umol/L)	90 days
Primary	Vitamin B12	Circulating Serum Vitamin B12 Concentrations (pg/mL)	90 days
Primary	Folate	Circulating Serum Folate Concentrations (ng/mL)	90 days
Primary	Red Blood Cell Folate	Circulating Red Blood Cell Folate Concentrations (nmol/L)	90 days
Primary	Zinc	Circulating Serum Zinc Concentrations (ug/dL)	90 days
Primary	Vitamin C	Serum Vitamin C Concentrations (	90 days
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.	90 days
Secondary	Dietary habits	Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	90 Days
Secondary	Gastrointestinal Health	Gastrointestinal symptom rating scale (GSRS). Symptom score change after 90 days of administration, compared to Baseline. Score base on a 1-7 scale with a higher score meaning a worse outcome.	90 Days
Secondary	Fatigue & energy	Multidimensional Fatigue Inventory (MFI).The MFI is a 20-item instrument consisting of several subscales including general fatigue and reduced activity and will be assessed after 90 days of administration compared to baseline.	90 Days
Secondary	Well-being	World Health Organization-5 Well-being Index Questionnaire.The World Health Organization-5 Well-Being Index is a brief scale, composed of five questions in which the participants indicate in each one of them, based on the last two weeks, the frequency of their sensations, being 0 (at no time) and 5 (all of the time). The result is given as the sum of the numbers of each statement, with values ranging from 0, which represents the worst possible quality of life and 25, which is associated with the best possible quality of life. Will be assessed at baseline and after 90 days of administration.	90 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	90 Days
Secondary	Complete Blood Count	Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit	90 Days