Personalized Dietary Program and Markers of Wellness

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy, Metabolism

Intervention / Treatment
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* Other: Personalized dietary and wellness program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic composite score | A composite score that includes aggregated changes in blood biomarkers (glucose, C-peptide, high-density lipoprotein cholesterol, total cholesterol, and triglyceride levels). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | systolic and diastolic blood pressures | 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 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 | composite score and individual ratings from the WHOQOL-BREF questionnaire | 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 sleep time | weekly averages of hours from a Fitbit® | 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 ratings of diet/food behavior | composite score from the Diet Self-efficacy Questionnaire and Food Behavior and Activity Inventory | 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 activity | weekly averages of hours from a Fitbit® | 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 food intake | weekly averages of nutrients and food intake from diet records | 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 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 | composite score and individual ratings from the Perceived Stress Scale | 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 C-peptide | 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). | 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 disposition index | 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). | 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) | 
| Changes in insulin indices | 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. | 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) | 
| Changes in lipid paramaters | 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. | 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 glucose | 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). | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolism, personalized dietary and wellness program, oral protein glucose lipid tolerance test, behavior, health, body composition, single nucleotide polymorphisms, genotype, dietary and wellness coaching/advice, liquid meal challenge test