Personalized Dietary Program and Markers of Wellness

Habit, LLC

Status: Completed

Conditions: Metabolism; Healthy

Treatments: Other: Personalized dietary and wellness program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03424395

Habit-1701

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Personalized dietary and wellness program

Other group

Description:

An integrated personalized nutrition program which includes a combination of dietary and wellness advice/counseling on wellness and meals, or dietary and wellness advice/counseling alone, each for 10 weeks.

Treatment:

Other: Personalized dietary and wellness program