A Clinical Trial to Evaluate the Efficacy of a Healthy Meal Plan in Improving Health Biomarkers and Promoting Healthy Weight Management.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Blood Lipid Biomarkers (LDL, HDL, Triglycerides)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Green Chef Meal Delivery Program (Dietary Supplement)
Control Group
Participants in the control group will continue their usual eating habits with no dietary changes for 16 weeks.
结局指标
主要结局
Change in Blood Lipid Biomarkers (LDL, HDL, Triglycerides)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Self-Reported Health Perceptions(Baseline, Week 4, Week 8, Week 12, Week 16)