Healthy DietNCT07140978
A Clinical Trial to Evaluate the Efficacy of a Healthy Meal Plan in Improving Health Biomarkers and Promoting Healthy Weight Management.
A study testing Green Chef Meal Delivery Program in people with Healthy Diet and Healthy Nutrition, run by Green Chef Corporation at 1 site in United States.
Trial 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 well-being. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Healthy Nutrition
- What is being tested?
- Green Chef Meal Delivery Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Diet, Healthy Nutrition
- Being tested
- Green Chef Meal Delivery Program
- Keywords
- Healthy meal plan, Weight management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Chef Meal Delivery ProgramDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Dietary Supplement: Green Chef Meal Delivery Program |
| Control Group | No intervention | Participants in the control group will continue their usual eating habits with no dietary changes for 16 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 8, Week 16
Secondary outcomes (1)
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start19 Nov 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Chef Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140978
- Sponsor's protocol ID
- 20678
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy of a Healthy Meal Plan in Improving Health Biomarkers and Promoting Healthy Weight Management.
- ClinicalTrials.gov ID
- NCT07140978
- Acronym / sponsor ID
- 20678
- Conditions
- Healthy Diet, Healthy Nutrition
- Keywords
- Healthy meal plan, Weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Green Chef CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Green Chef Meal Delivery ProgramParticipants 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. |
| Control Group | No intervention | –Participants in the control group will continue their usual eating habits with no dietary changes for 16 weeks. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Chef Meal Delivery ProgramParticipants 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. | Dietary supplement | Intervention Group |
Primary outcome
Change in Blood Lipid Biomarkers (LDL, HDL, Triglycerides)
Time frame: Baseline to Week 16
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.
Change in Weight and Body Composition
Time frame: Baseline, Week 8, Week 16
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.
Change in Blood Pressure
Time frame: Baseline, Week 8, Week 16
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.
1 secondary outcome
Change in Self-Reported Health Perceptions
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Chef Meal Delivery Program in people with Healthy Diet and Healthy Nutrition, run by Green Chef Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Lipid Biomarkers (LDL, HDL, Triglycerides) (time frame: Baseline to Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.