Campbell Soup Company
Camden, New Jersey, 08103, United States
NCT Number: NCT03424395
The objective of this study is to determine the impact of an integrated personalized dietary and wellness program which includes dietary advice, meals, and counseling on health and wellness.
Looking for future studies?
Notify Me30 year–65 year
All sexes
Interventional
Not applicable
Camden, New Jersey, 08103, United States
The objective of this study is to determine the impact of an integrated personalized dietary and wellness program, which includes personalized dietary advice, meals, and behavior guidance, on markers of health and wellness, body composition, and psychosocial measures. Behavior questionnaires, motivational interviewing, psychosocial questionnaires, and participants' self-generated data on diet, preferences, activity, and sleep will be used in combination with anthropometric and biological data (fasted blood-based measures following an oral protein glucose lipid tolerance test [liquid meal challenge test], and selected single nucleotide polymorphisms) to create individualized, tailored dietary advice, meal and counseling plans.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
A composite score that includes aggregated changes in blood biomarkers (glucose, C-peptide, high-density lipoprotein cholesterol, total cholesterol, and triglyceride levels).
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
systolic and diastolic blood pressures
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
composite score and individual ratings from the WHOQOL-BREF questionnaire
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
weekly averages of hours from a Fitbit®
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
composite score from the Diet Self-efficacy Questionnaire and Food Behavior and Activity Inventory
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
weekly averages of hours from a Fitbit®
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
weekly averages of nutrients and food intake from diet records
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
composite score and individual ratings from the Perceived Stress Scale
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
The change from 0 to 30 min, 0 to 120 min, and area under the curve from 0 to 120 min pre- and post-oral protein glucose lipid tolerance test (liquid meal challenge test).
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
The change from 0 to 30 min, 0 to 120 min, and area under the curve from 0 to 120 min pre- and post-oral protein glucose lipid tolerance test (liquid meal challenge test).
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
The change from 0 to 30 min, 0 to 120 min, and area under the curve from 0 to 120 min pre- and post-oral protein glucose lipid tolerance test (liquid meal challenge test) for hepatic insulin index and Matsuda insulin sensitivity index.
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
The change from 0 to 30 min, 0 to 120 min, and area under the curve from 0 to 120 min pre- and post-oral protein glucose lipid tolerance test (liquid meal challenge test) for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides.
Time frame: The change between the run-in (control) period (baseline; 10 weeks) and each intervention period (personalized advice + meals or personalized advice only; 10 weeks each)
The change from 0 to 30 min, 0 to 120 min, and area under the curve from 0 to 120 min pre- and post-oral protein glucose lipid tolerance test (liquid meal challenge test).
Habit, LLC
Industry
A Clinical Trial to Evaluate the Effects of Proprietary Personalized Dietary Programs on Markers of Health and Wellness, Body Composition, and Quality of Life
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07020234
Behavior, Healthy
St Louis, Missouri, United States
View Trial DetailsNCT04802499
Behavior, Health Knowledge, Attitudes, Practice
Hatay, Merkez, Turkey (Türkiye)
View Trial DetailsNCT05927038
Behavior, Healthy
Cork, Ireland
View Trial DetailsNCT05927103
Behavior, Healthy
Cork, Ireland
View Trial Details