A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2021
CompletedMarch 12, 2021
March 1, 2021
6 months
March 8, 2021
March 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Weight Change
16 Weeks
Study Arms (1)
Intervention
EXPERIMENTALLow carbohydrate, high protein meals
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Freshly, Inc.lead
- Biofortis Clinical Research, Inc.collaborator
Study Sites (1)
Biofortis Clinical Research
Addison, Illinois, 60101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 11, 2021
Study Start
March 15, 2021
Primary Completion
September 23, 2021
Study Completion
September 23, 2021
Last Updated
March 12, 2021
Record last verified: 2021-03