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CompletedNCT03424395Updated Feb 25, 2019

Personalized Dietary Program and Markers of Wellness

An interventional study of Personalized dietary and wellness program in Healthy and Metabolism, sponsored by Habit, LLC. Completed at 1 site in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Habit, LLC · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • 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

Interventions

  • OtherPersonalized 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

05

What researchers measure

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).

    Time frame: 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

  1. Change in blood pressure

    systolic and diastolic blood pressures

    Time frame: 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)

  2. Change in body mass index

    Time frame: 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)

  3. Change in quality of life

    composite score and individual ratings from the WHOQOL-BREF questionnaire

    Time frame: 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)

  4. Change in sleep time

    weekly averages of hours from a Fitbit®

    Time frame: 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)

  5. Change in ratings of diet/food behavior

    composite score from the Diet Self-efficacy Questionnaire and Food Behavior and Activity Inventory

    Time frame: 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)

  6. Change in activity

    weekly averages of hours from a Fitbit®

    Time frame: 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)

  7. Change in food intake

    weekly averages of nutrients and food intake from diet records

    Time frame: 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)

  8. Change in heart rate

    Time frame: 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)

  9. Change in body weight

    Time frame: 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)

  10. Change in waist circumference

    Time frame: 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)

  11. Change in hip circumference

    Time frame: 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)

  12. Change in fat-free mass

    Time frame: 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)

  13. Change in fat mass

    Time frame: 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)

  14. Change in stress

    composite score and individual ratings from the Perceived Stress Scale

    Time frame: 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)

  15. 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).

    Time frame: 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)

  16. 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).

    Time frame: 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)

  17. 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.

    Time frame: 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)

  18. 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.

    Time frame: 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)

  19. 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).

    Time frame: 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)

06

Study locations

1 site
  • Campbell Soup Company
    Camden, New Jersey 08103, United States
07

References and documents

Publications

  • Blaak EE, Hul G, Verdich C, Stich V, Martinez A, Petersen M, Feskens EF, Patel K, Oppert JM, Barbe P, Toubro S, Anderson I, Polak J, Astrup A, Macdonald IA, Langin D, Holst C, Sorensen TI, Saris WH. Fat oxidation before and after a high fat load in the obese insulin-resistant state. J Clin Endocrinol Metab. 2006 Apr;91(4):1462-9. doi: 10.1210/jc.2005-1598. Epub 2006 Jan 31. PubMed 16449343 ↗
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PubMed 6668417 ↗
  • Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available. PubMed 4337382 ↗
  • Hardcastle SJ, Taylor AH, Bailey MP, Harley RA, Hagger MS. Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up. Int J Behav Nutr Phys Act. 2013 Mar 28;10:40. doi: 10.1186/1479-5868-10-40. PubMed 23537492 ↗
  • Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110. PubMed 1027738 ↗
  • Hunot C, Fildes A, Croker H, Llewellyn CH, Wardle J, Beeken RJ. Appetitive traits and relationships with BMI in adults: Development of the Adult Eating Behaviour Questionnaire. Appetite. 2016 Oct 1;105:356-63. doi: 10.1016/j.appet.2016.05.024. Epub 2016 May 20. PubMed 27215837 ↗
  • Johnson RK. Dietary intake--how do we measure what people are really eating? Obes Res. 2002 Nov;10 Suppl 1:63S-68S. doi: 10.1038/oby.2002.192. No abstract available. PubMed 12446861 ↗
  • 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. PubMed 26198450 ↗
  • Kolodziejczyk JK, Norman GJ, Roesch SC, Rock CL, Arredondo EM, Madanat H, Patrick K. Exploratory and confirmatory factor analyses and demographic correlate models of the strategies for weight management measure for overweight or obese adults. Am J Health Promot. 2015 Mar-Apr;29(4):e147-57. doi: 10.4278/ajhp.130731-QUAN-391. Epub 2014 Mar 26. PubMed 24670075 ↗
  • 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. PubMed 24462267 ↗
  • Resnicow K, McMaster F. Motivational Interviewing: moving from why to how with autonomy support. Int J Behav Nutr Phys Act. 2012 Mar 2;9:19. doi: 10.1186/1479-5868-9-19. PubMed 22385702 ↗
  • Stewart EE, Fox CH. Encouraging patients to change unhealthy behaviors with motivational interviewing. Fam Pract Manag. 2011 May-Jun;18(3):21-5. No abstract available. PubMed 21842805 ↗
  • Stich C, Knauper B, Tint A. A scenario-based dieting self-efficacy scale: the DIET-SE. Assessment. 2009 Mar;16(1):16-30. doi: 10.1177/1073191108322000. Epub 2008 Aug 14. PubMed 18703821 ↗
  • Stroeve JHM, van Wietmarschen H, Kremer BHA, van Ommen B, Wopereis S. Phenotypic flexibility as a measure of health: the optimal nutritional stress response test. Genes Nutr. 2015 May;10(3):13. doi: 10.1007/s12263-015-0459-1. Epub 2015 Apr 21. PubMed 25896408 ↗
  • Teeter BS, Kavookjian J. Telephone-based motivational interviewing for medication adherence: a systematic review. Transl Behav Med. 2014 Dec;4(4):372-81. doi: 10.1007/s13142-014-0270-3. PubMed 25584086 ↗
  • 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. PubMed 2650734 ↗
  • van Ommen B, van der Greef J, Ordovas JM, Daniel H. Phenotypic flexibility as key factor in the human nutrition and health relationship. Genes Nutr. 2014 Sep;9(5):423. doi: 10.1007/s12263-014-0423-5. Epub 2014 Aug 9. PubMed 25106484 ↗
  • Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. PubMed 9626712 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03424395
Lead sponsor
Habit, LLC
Collaborators
TNO, University of California, San Diego
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Oct 28, 2017
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018
Last update
Feb 25, 2019

Study contacts

Joshua C Anthony, PhD
principal investigator · Habit, LLC
Barbara L Winters, PhD, RD
principal investigator · Winters Nutrition Associates LLC
Kristin M Nieman, PhD
study director · Katalyses LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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