NCT04793113UnknownNot Applicable
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Freshly, Inc.2 sites in 1 country50 target enrollmentStarted: March 15, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Weight Change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
Weight Change
Time Frame: 16 Weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight LossOverweightNCT00529919University of Alabama at Birmingham53
Recruiting
Not Applicable
Mobile Applet for Weight Management in Obese Heart Failure PatientsOverweight and ObesityWeight LossHeart Failure With Reduced Ejection FractionHeart FailureNCT06455878Heart Health Research Center830
Completed
Not Applicable
Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)Appetitive BehaviorNCT05892003University of Aberdeen20
Completed
Phase 1
A Food Effect Study of JAB-21822 in Healthy SubjectsFood Effect in Healthy ParticipantsNCT05875493Allist Pharmaceuticals, Inc.18
Unknown
Phase 1
A Food-Effect Study of SHC014748M in Healthy SubjectsHealthy VolunteerNCT04006860Nanjing Sanhome Pharmaceutical, Co., Ltd.16