Status:
UNKNOWN
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Lead Sponsor:
Freshly, Inc.
Collaborating Sponsors:
Biofortis Clinical Research, Inc.
Conditions:
Weight Loss
Eligibility:
All Genders
21-55 years
Phase:
NA
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 overwei...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04793113
Start Date
March 15 2021
End Date
September 23 2021
Last Update
March 12 2021
Active Locations (1)
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1
Biofortis Clinical Research
Addison, Illinois, United States, 60101