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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Aging; Nutrition, Healthy; Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: AG1 - Nutritional Supplement

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen O'Gorman; Phone Number: (805) 292-0714.; Email: ellen@citruslabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin + Flavoring	Dietary supplement: Placebo; Maltodextrin placebo
Experimental: AG1 - Nutritional Supplement; AG1, a foundational nutritional supplement	Dietary supplement: AG1 - Nutritional Supplement; A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homocysteine	Circulating Serum Homocysteine Concentrations (umol/L)	90 days
Vitamin B12	Circulating Serum Vitamin B12 Concentrations (pg/mL)	90 days
Folate	Circulating Serum Folate Concentrations (ng/mL)	90 days
Red Blood Cell Folate	Circulating Red Blood Cell Folate Concentrations (nmol/L)	90 days
Zinc	Circulating Serum Zinc Concentrations (ug/dL)	90 days
Vitamin C	Serum Vitamin C Concentrations (	90 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary habits	Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	90 Days
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
Complete Blood Count	Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit	90 Days
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
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
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

Collaborators and Investigators

• Sponsor: Athletic Greens International
• Collaborators: Citruslabs
• Investigators: Principal Investigator: Ellen O'Gorman, Citruslabs

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): February 4, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AG-01-0324

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No