Personalized Dietary Program and Markers of Wellness

Completed · Not applicable

Conditions studied: Healthy, Metabolism

In brief

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.

Key facts

Study ID

NCT03424395

Run by

Habit, LLC

People needed

110

Starts

2017-10-28

Expected to finish

2018-12-21

Last updated by the study team

2019-02-25

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, 30-65 years of age, inclusive.
• BMI 18.5-39.9 kilograms per meters squared.
• Willing to follow study program instructions, including consumption of meals on site (5 days/week; breakfast and lunch), consumption of all provided meals, use of a Fitbit®, self-administered capillary blood draws and dried blood spot collection, and visit schedule, where relevant.
• Willing and able to comply with the visit/contact schedule.
• Willing to avoid vigorous activity and alcohol consumption (24 h) and willing to fast (10-14 h, water only) prior to completion of the at-home oral protein glucose lipid tolerance test.
• Normally active and judged to be in good health on the basis of the medical history.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
• Subject has access to an internet-ready device and email.

You may not qualify if…

• A history or presence of clinically important endocrine, cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders that could interfere with the interpretation of the study results.
• A history or presence of a gastrointestinal condition that could potentially interfere with digestion and absorption of the study product including, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, and history of frequent diarrhea; and gastroparesis.
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
• A history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• A history of unconventional sleep patterns.
• Major trauma or a surgical event within 3 months of screening.
• Nicotine users.
• Use of medications which can alter the lipid profile with the exception of stable statin use.
• Unstable use of any thyroid medication.
• Use of antibiotics, hypoglycemic medications, and/or systemic corticosteroids.
• Signs or symptoms of an active infection.
• Current or recent history of drug or alcohol abuse.
• Known allergy and/or sensitivity to the study foods or products.
• Extreme dietary habits (e.g., very high protein diets, vegan, very low carbohydrate, etc.).
• A change (increase or decrease) in body weight of >10%.
• Females who are pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
• Study staff or those who will be involved in the conduct of the study.

Where it is running

• Campbell Soup Company — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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