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

Status unconfirmed · Not applicable

Conditions studied: Weight Loss

In brief

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.

Key facts

Study ID

NCT04793113

Run by

Freshly, Inc.

People needed

50

Starts

2021-03-15

Expected to finish

2021-09-23

Last updated by the study team

2021-03-12

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• Biofortis Clinical Research — Addison, Illinois, United States

Full record on ClinicalTrials.gov

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