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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04793113
Enrollment
50
Registered
2021-03-11
Start date
2021-03-15
Completion date
2021-09-23
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

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.

Interventions

OTHERFreshlyFit Meals

FreshlyFit meals are low carbohydrate, high protein meals

Sponsors

Biofortis Clinical Research, Inc.
CollaboratorINDUSTRY
Freshly, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Weight Change16 Weeks

Countries

United States

Contacts

Primary ContactBrooke Scheller
brooke.scheller@freshly.com732-773-1534

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026