Personalized Dietary Program and Markers of Wellness

NCT03424395 | Completed

• 1 other identifier: Habit-1701
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Personalized dietary and wellness program

OTHER

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

Interventions

Personalized dietary and wellness program OTHER

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

Personalized dietary and wellness program

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Habit, LLC: lead
• TNO: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Campbell Soup Company

Camden, New Jersey, 08103, United States

Location

Related Publications (18)

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• Kardinaal AF, van Erk MJ, Dutman AE, Stroeve JH, van de Steeg E, Bijlsma S, Kooistra T, van Ommen B, Wopereis S. Quantifying phenotypic flexibility as the response to a high-fat challenge test in different states of metabolic health. FASEB J. 2015 Nov;29(11):4600-13. doi: 10.1096/fj.14-269852. Epub 2015 Jul 21.

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• Kristal AR, Kolar AS, Fisher JL, Plascak JJ, Stumbo PJ, Weiss R, Paskett ED. Evaluation of web-based, self-administered, graphical food frequency questionnaire. J Acad Nutr Diet. 2014 Apr;114(4):613-21. doi: 10.1016/j.jand.2013.11.017. Epub 2014 Jan 24.

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• van Amelsvoort JM, van Stratum P, Kraal JH, Lussenburg RN, Houtsmuller UM. Effects of varying the carbohydrate:fat ratio in a hot lunch on postprandial variables in male volunteers. Br J Nutr. 1989 Mar;61(2):267-83. doi: 10.1079/bjn19890115.

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Related Links

• Institute of Medicine - Dietary Reference Intakes
• World Health Organization - Physical Activity Definitions
• World Health Organization: Waist and Hip Circumference Ratio

MeSH Terms

Conditions

Behavior

Interventions

Health Promotion

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joshua C Anthony, PhD

  Habit, LLC

  PRINCIPAL INVESTIGATOR

• Barbara L Winters, PhD, RD

  Winters Nutrition Associates LLC

  PRINCIPAL INVESTIGATOR

• Kristin M Nieman, PhD

  Katalyses LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 7, 2018
• Study Start: October 28, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

US (1)