Back to resultsA Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Primary Purpose
Weight Loss
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreshlyFit Meals
Sponsored by
About this trial
This is an interventional other trial for Weight Loss
Eligibility Criteria
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).
Sites / Locations
- Biofortis Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Low carbohydrate, high protein meals
Outcomes
Primary Outcome Measures
Weight Change
Secondary Outcome Measures
Full Information
NCT ID
NCT04793113
First Posted
March 8, 2021
Last Updated
March 10, 2021
Sponsor
Freshly, Inc.
Collaborators
Biofortis Clinical Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04793113
Brief Title
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Official Title
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
September 23, 2021 (Anticipated)
Study Completion Date
September 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Freshly, Inc.
Collaborators
Biofortis Clinical Research, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Low carbohydrate, high protein meals
Intervention Type
Other
Intervention Name(s)
FreshlyFit Meals
Intervention Description
FreshlyFit meals are low carbohydrate, high protein meals
Primary Outcome Measure Information:
Title
Weight Change
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Scheller
Phone
732-773-1534
Email
brooke.scheller@freshly.com
Facility Information:
Facility Name
Biofortis Clinical Research
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Kaden
Phone
773-454-8378
Email
valerie.kaden@mxns.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
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