Personalized Dietary Program and Markers of Wellness

Sponsor

Habit, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03424395

Collaborator

TNO (Other), University of California, San Diego (Other)

110

Enrollment

Location

Arm

13.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Metabolism	Other: Personalized dietary and wellness program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.Single arm (open-label) containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only.

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Oct 28, 2017

Actual Primary Completion Date :

Dec 21, 2018

Actual Study Completion Date :

Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Personalized dietary and wellness program 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.	Other: Personalized dietary and wellness program Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only

Arm

Intervention/Treatment

Other: Personalized dietary and wellness program

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.

Other: Personalized dietary and wellness program

Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only

Outcome Measures

Primary Outcome Measures

Change in metabolic composite score [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).

Secondary Outcome Measures

Change in blood pressure [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
Change in body mass index [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)]
Change in quality of life [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
Change in sleep time [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®
Change in ratings of diet/food behavior [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
Change in activity [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®
Change in food intake [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
Change in heart rate [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)]
Change in body weight [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)]
Change in waist circumference [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)]
Change in hip circumference [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)]
Change in fat-free mass [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)]
Change in fat mass [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)]
Change in stress [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
Change in C-peptide [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).
Change in disposition index [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).
Changes in insulin indices [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.
Changes in lipid paramaters [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.
Change in glucose [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Campbell Soup Company	Camden	New Jersey	United States	08103

Sponsors and Collaborators

Habit, LLC
TNO
University of California, San Diego

Investigators

Principal Investigator: Joshua C Anthony, PhD, Habit, LLC
Principal Investigator: Barbara L Winters, PhD, RD, Winters Nutrition Associates LLC
Study Director: Kristin M Nieman, PhD, Katalyses LLC