A Clinical Trial to Evaluate the Efficacy of a Healthy Meal Plan in Improving Health Biomarkers and Promoting Healthy Weight Management.

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 well-being. The study aims to measure improvements in blood lipids, body composition, weight, and blood pressure, as well as subjective health indicators through surveys.

Study Overview

• Status: Completed
• Conditions: Healthy Diet; Healthy Nutrition
• Intervention / Treatment: Dietary supplement: Green Chef Meal Delivery Program

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Citruslabs

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants in the intervention group will receive Green Chef meals for lunch and dinner, along with guidelines for preparing healthy breakfasts. Participants will follow this diet for 16 weeks.	Dietary supplement: Green Chef Meal Delivery Program; Participants will receive Green Chef meals for lunch and dinner, delivered weekly for 16 weeks. Meals include organic produce, responsibly sourced protein, and nutritionist-approved recipes. Participants will also receive guidelines for preparing healthy breakfasts and will use smart devices to record biomarker data.
No Intervention: Control Group; Participants in the control group will continue their usual eating habits with no dietary changes for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Lipid Biomarkers (LDL, HDL, Triglycerides)	Blood lipid levels (LDL, HDL, triglycerides) will be measured at baseline and week 16 via fasting blood draws to evaluate the effect of the Green Chef meal plan on cardiovascular health.	Baseline to Week 16
Change in Weight and Body Composition	Body weight and composition will be measured using a Withings smart scale at baseline, week 8, and week 16 to assess changes related to the dietary intervention.	Baseline, Week 8, Week 16
Change in Blood Pressure	Systolic and diastolic blood pressure will be measured using a Withings smart blood pressure cuff at baseline, week 8, and week 16 to assess impact of the meal plan on cardiovascular function.	Baseline, Week 8, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Reported Health Perceptions	Participants will complete surveys at 5 time points to assess subjective changes in energy, digestion, eating habits, physical appearance, and overall well-being.	Baseline, Week 4, Week 8, Week 12, Week 16

Collaborators and Investigators

• Sponsor: Green Chef Corporation
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: August 21, 2025
• First Posted (Estimated): August 26, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Weight management; Healthy meal plan
• Other Study ID Numbers: 20678

Drug and device information, study documents

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