Weight Loss
Conditions
Brief summary
The primary objective of this trial is to examine the weight-loss efficacy of Freshly Fit meals, as well as body composition, waist/hip circumference, metabolic markers, and quality of life in overweight and obese adults.
Interventions
FreshlyFit meals are low carbohydrate, high protein meals
Sponsors
Study design
Eligibility
Inclusion criteria
* Male or female, 21-55 years of age, inclusive, at Visit 1 (Day -10). * BMI of 25.00 to 34.99 kg/m2, inclusive, at Visits 1 and 2 (Day -10 and -3). * Non-smoker and has no plans to change smoking habits during the study period. * Willing to follow study instructions. * Willing and able to comply with the visit schedule (e.g., subjects with travel plans and cannot fully comply with study instructions will be excluded).
Exclusion criteria
* Abnormal laboratory test result of clinical significance at Visit 1 (Day -10), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -3) for subjects with abnormal laboratory test results. * History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator. * History of gastrointestinal surgery for weight reducing purposes. * Participation in a weight loss trial within 12 mo of Visit 1 (Day -10). * Weight loss or gain ≥10 lb (4.5 kg) within the 6 mo prior to Visit 1 (Day -10). Participation in a program/service intended to alter body weight (e.g., Nutrisystem, Weight Watchers, Noom) within 6 mo of Visit 1 (Day -10).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Change | 16 Weeks |
Countries
United States