Clinical trial NCT03424395: Personalized Dietary Program and Markers of Wellness
Official title: A Clinical Trial to Evaluate the Effects of Proprietary Personalized Dietary Programs on Markers of Health and Wellness, Body Composition, and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Metabolism
Keywords: personalized dietary and wellness program
oral protein glucose lipid tolerance test
metabolism
behavior
health
body composition
single nucleotide polymorphisms
genotype
dietary and wellness coaching/advice
liquid meal challenge test
Lead sponsor: Habit, LLC
Sponsor class: INDUSTRY
Collaborators: name: TNO
name: University of California, San Diego
First posted: 2018-02-07
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm (open-label) containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in metabolic composite score
timeFrame: 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)
Secondary outcomes:
measure: Change in blood pressure
timeFrame: 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)
measure: Change in body mass index
timeFrame: 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)
measure: Change in quality of life
timeFrame: 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)
measure: Change in sleep time
timeFrame: 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)
measure: Change in ratings of diet/food behavior
timeFrame: 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)
measure: Change in activity
timeFrame: 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)
measure: Change in food intake
timeFrame: 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)
measure: Change in heart rate
timeFrame: 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)
measure: Change in body weight
timeFrame: 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)
measure: Change in waist circumference
timeFrame: 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)
measure: Change in hip circumference
timeFrame: 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)
measure: Change in fat-free mass
timeFrame: 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)
measure: Change in fat mass
timeFrame: 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)
measure: Change in stress
timeFrame: 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)
measure: Change in C-peptide
timeFrame: 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)
measure: Change in disposition index
timeFrame: 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)
measure: Changes in insulin indices
timeFrame: 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)
measure: Changes in lipid paramaters
timeFrame: 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)
measure: Change in glucose
timeFrame: 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)
Other outcomes:
Locations:
city: Camden
country: United States
facility: Campbell Soup Company
state: New Jersey
Study officials:
affiliation: Habit, LLC
name: Joshua C Anthony, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Winters Nutrition Associates LLC
name: Barbara L Winters, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Katalyses LLC
name: Kristin M Nieman, PhD
role: STUDY_DIRECTOR
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