Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy of a Healthy Meal Plan in Improving Health Biomarkers and Promoting Healthy Weight Management.
Lead Sponsor:
Green Chef Corporation
Collaborating Sponsors:
Citruslabs
Conditions:
Healthy Diet
Healthy Nutrition
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
This is a 16-week, two-arm, hybrid, randomized controlled clinical trial designed to evaluate the effect of the Green Chef Calorie Smart \& Brain Health meal plans on health biomarkers and perceived w...
Eligibility Criteria
Inclusion
- Males and females aged 25 years or older.
- Participants who struggle with healthy weight management and have a desire to lose weight.
- Participants who eat takeout or at restaurants at least four times per week.
- Participants not currently using a meal kit.
- Participants who are willing to cook meals twice daily for the 16-week study period.
- Participants who are willing to cook and consume meals as instructed, fill out regular questionnaires, take regular weight and blood pressure measurements, and attend blood tests at Quest for Baseline and Endline assessments for the 16-week study period.
- Participants must not have introduced any new prescription medications, supplements, or herbal remedies targeting weight management within the past three months.
- Participants must be willing to discontinue any prescription medications, supplements, or herbal remedies that target weight management for the duration of the trial.
- Participants must agree to not introduce any new prescription medications, vitamins, minerals, nutraceuticals, or herbal supplements for the duration of the trial.
- Participants must consider themselves in good general health and not have any chronic health conditions that could impact their participation in the study.
- Participants must reside in the United States.
Exclusion
- Individuals who have undergone surgeries or invasive treatments in the last six months or have any planned for the duration of the trial.
- Individuals who have undergone weight loss surgery.
- Individuals who have experienced dramatic weight changes (gain or loss) within the past three months.
- Individuals who consider themselves to be chronic dieters or "always on a diet" (e.g., those who have been dieting or restricting calories for a prolonged period of time or who tend to jump from one diet to the next regularly).
- Individuals with a known history of severe digestive disorders, including but not limited to acid reflux, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), ulcerative colitis (UC), Crohn's disease, or gastrointestinal tract surgeries.
- Individuals with a known history of any chronic illness such as hypertension, diabetes, or cancer.
- Individuals with any known allergies or hypersensitivities to foods.
- Individuals with a history of disordered eating behaviors or an eating disorder.
- Individuals who regularly take laxatives, or antacids.
- Individuals who regularly take anticoagulants (also referred to as blood thinners).
- Individuals with chronic health conditions, including oncological or psychiatric disorders, that could impact participation.
- Individuals with known serious allergic reactions requiring the use of an Epi-Pen.
- Individuals who are currently pregnant, trying to conceive, or breastfeeding.
- Individuals currently participating or planning to participate in another research study within the next 16 weeks.
- Individuals with a history of substance abuse.
- Individuals with specific dietary restrictions that make consuming the test meals impossible (e.g., pescatarian, vegetarian, vegan, Whole 30, FODMAP).
- Anyone who has taken a GLP-1 agonist in the last 3 months.
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07140978
Start Date
November 19 2024
End Date
June 30 2025
Last Update
August 26 2025
Active Locations (1)
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1
Citruslabs
Las Vegas, Nevada, United States, 89118