Clinical trial NCT06332898: The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life
Official title: The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Gastrointestinal Microbiome
Healthy Aging
Lead sponsor: Athletic Greens International
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-03-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo Controlled Design
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Homocysteine
timeFrame: 90 days
measure: Vitamin B12
timeFrame: 90 days
measure: Folate
timeFrame: 90 days
measure: Red Blood Cell Folate
timeFrame: 90 days
measure: Zinc
timeFrame: 90 days
measure: Vitamin C
timeFrame: 90 days
measure: Gut Microbiome
timeFrame: 90 days
Secondary outcomes:
measure: Dietary habits
timeFrame: 90 Days
measure: Gastrointestinal Health
timeFrame: 90 Days
measure: Fatigue & energy
timeFrame: 90 Days
measure: Well-being
timeFrame: 90 Days
measure: Complete Metabolic Blood Panel
timeFrame: 90 Days
measure: Complete Blood Count
timeFrame: 90 Days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Ellen O'Gorman
role: PRINCIPAL_INVESTIGATOR
References: