Gastrointestinal Microbiome, Healthy Aging, Nutrition, Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAG1 - Nutritional Supplement
A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
DIETARY_SUPPLEMENTPlacebo
Maltodextrin placebo
Sponsors
Citruslabs
Athletic Greens International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, Double-Blind, Placebo Controlled Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome | 90 days | 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. |
| Homocysteine | 90 days | Circulating Serum Homocysteine Concentrations (umol/L) |
| Vitamin B12 | 90 days | Circulating Serum Vitamin B12 Concentrations (pg/mL) |
| Folate | 90 days | Circulating Serum Folate Concentrations (ng/mL) |
| Red Blood Cell Folate | 90 days | Circulating Red Blood Cell Folate Concentrations (nmol/L) |
| Zinc | 90 days | Circulating Serum Zinc Concentrations (ug/dL) |
| Vitamin C | 90 days | Serum Vitamin C Concentrations ( |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Health | 90 Days | 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. |
| Fatigue & energy | 90 Days | 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. |
| Well-being | 90 Days | 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. |
| Complete Metabolic Blood Panel | 90 Days | Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine |
| Complete Blood Count | 90 Days | Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit |
| Dietary habits | 90 Days | Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool |
Countries
United States
Outcome results
None listed