A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults

Not Applicable

• Conditions: Weight Loss
• Interventions: Other: FreshlyFit Meals

• Registration Number: NCT04793113
• Lead Sponsor: Freshly, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-12
• Study Start: 2021-03-15
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	FreshlyFit Meals	Low carbohydrate, high protein meals

Primary Outcome Measures

Name	Time	Method
Weight Change	16 Weeks

Trial Locations

Locations (1)

Biofortis Clinical Research; 🇺🇸 Addison, Illinois, United States