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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04793113
• Other study ID #: BIO-2105
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 23, 2021

Study information

• Verified date: March 2021
• Source: Freshly, Inc.
• Contact: Brooke Scheller
• Phone: 732-773-1534
• Email: brooke.scheller[@]freshly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Weight Loss

Intervention

Other:
• FreshlyFit Meals
FreshlyFit meals are low carbohydrate, high protein meals

Locations

Country	Name	City	State
United States	Biofortis Clinical Research	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Freshly, Inc.	Biofortis Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change		16 Weeks