Personalized Dietary Program and Markers of Wellness



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:30 - 65
Updated:2/27/2019
Start Date:October 28, 2017
End Date:December 21, 2018

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A Clinical Trial to Evaluate the Effects of Proprietary Personalized Dietary Programs on Markers of Health and Wellness, Body Composition, and Quality of Life

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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
1
site
1 Campbell Place
Camden, New Jersey 08103
Phone: 856-285-6143
?
mi
from
Camden, NJ
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