This study is a triple-blind, placebo-controlled, randomized controlled trial of 120 adults that will evaluate the impact of a novel nutritional supplement on improving nutrient gaps and changing nutrient status and the gut microbiome among glucagon-like peptide-1 receptor agonist (GLP-1 RA) users.
Be male or female
Be aged 18-59.
Has a BMI between 20-31.9.
Anyone currently taking GLP-1 medication at their maintenance dose (week 8+), and without any plans to alter their dosage. This includes: Semaglutide (Ozempic®, Wegovy®, Rybelsus®), Liraglutide (Saxenda®, Victoza®), Dulaglutide (Trulicity®), Exenatide (Byetta®, Bydureon®), Lixisenatide (Adlyxin®)
Anyone with a diagnosis of Type I or Type II diabetes.
Anyone with a diagnosis of any metabolic health condition, such as hypertension and dyslipidemia.
Anyone who has taken any multivitamin/multimineral supplements within the past 3 months.
Anyone who has taken a probiotic supplement within the past month.
Parallel
AG1 - Nutritional Supplement
Dietary supplementAG1 - Nutritional Supplement
Placebo
Dietary supplementMaltodextrin Placebo
Nutrient Gaps
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
Nutrient Status Markers
Circulating concentrations of nutrient status (homocysteine, folate, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamin, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Zinc)
Gut Microbiome
Examine changes in the gut microbiome via fecal metagenomics
GI Symptoms
The Gastrointestinal Symptom Rating Scale will be provided to assess the effect of the intervention on GI symptoms. Scores range from 1 to 7 with a higher score indicating a higher level of discomfort
Digestive Quality of Life
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
Functional Impairment
The Sheehan Disability Scale will be utilized to assess functional impairment.
Ingestive Behavior
Food cravings will be measured using the General Food Cravings Questionnaire.
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