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

Freshly, Inc.1 site in 1 country50 target enrollmentMarch 15, 2021

ConditionsWeight Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Weight Loss
Sponsor: Freshly, Inc.
Enrollment: 50
Locations: 1
Primary Endpoint: Weight Change
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 15, 2021

End Date

September 23, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Freshly, Inc.

Responsible Party

Sponsor

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).