A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer (NWHS)

• ClinicalTrials.gov Identifier: NCT03430141
• Recruitment Status: Completed
• First Posted: February 12, 2018
• Last Update Posted: September 22, 2020
• Sponsor: Northern Arizona University
• Information provided by (Responsible Party): Jay Sutliffe, Northern Arizona University

Study Description

Brief Summary:

The Nutritarian Women's Health Study (NWHS) is a long-term hybrid effectiveness-implementation study on the effect of the Nutritarian Diet on the occurrence, recurrence, and progression of chronic diseases (including all forms of cancer and cardiometabolic risk factors).

Condition or disease	Intervention/treatment	Phase
Chronic Disease; Cancer; Cardiovascular Diseases; Diabetes Mellitus; Lifestyle-related Condition; Mental Health Wellness 1; Sleep; Nutritional and Metabolic Disease; Nutrition Related Cancer; Nutritional Imbalance; Thyroid	Other: Nutritarian Diet-style	Not Applicable

Detailed Description:

The Nutritional Research Foundation, in conjunction with Northern Arizona University, is conducting a long-term health study for women ages 18 and older. This study will address the effects of a nutrient dense, plant-rich diet on the long-term risks of cancer and other chronic diseases.

Participants enroll in a 30-day training module which outlines the benefits of a nutrient-dense, plant-rich diet. At the conclusion of those videos and written modules, they take a short quiz to assess their knowledge and they can enroll in the full study.

All participation is online with ongoing modules on nutrition and lifestyle. There is a comprehensive health history and lifestyle index to be completed. Nutrition questionnaires will be administered an average of every 3-6 months; PHQ-9 (Patient Health Questionnaire) & PSQI (Pittsburgh Sleep Quality Index) questionnaires an average of every 12 months; serum cardiometabolic measures and liquid biopsies an average of every 18 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2898 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Hybrid effectiveness-implementation
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Nutritarian Women's Health Study to Reduce Chronic Disease
• Actual Study Start Date: October 31, 2016
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention for all participants; Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol.	Other: Nutritarian Diet-style; Nutritarian Diet-style: Daily consumption of greens, beans/legumes, a variety of other vegetables, fresh or frozen fruits, nuts, seeds and whole grains. Participants are encouraged to minimize consumption of refined grains, vegetable oils, processed foods, and to limit animal products.

Outcome Measures

Primary Outcome Measures :

1. Nutrition Intervention [ Time Frame: Every 12 months, up to 10 years. ]
   Adherence to the recommended dietary protocol with the Nutritarian Health Indicator (©Joel Furhman MD). Scored by points (90-100 excellent, 80-89 good, 70-79 average, <69 poor).

Secondary Outcome Measures :

1. Weight Management [ Time Frame: Every 12 months, up to 10 years. ]
   Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m^2.
2. Waist Measurement [ Time Frame: Every 12 months, up to 10 years. ]
   Self-measured and reported measurements in inches.
3. Hip Measurement [ Time Frame: Every 12 months, up to 10 years. ]
   Self-measured and reported measurements in inches.
4. Mental Health [ Time Frame: Every 12 months, up to 10 years. ]
   PHQ-9 (Patient Health Questionnaire-9). Tool designed for screening, diagnosing, monitoring and measuring the severity of depression. Scoring: 5-9 (minimal symptoms), 10-14 (minor depression, dysthymia, mild major depression), 15-19 (major depression, moderately severe), and >20 (major depression, severe).
5. Sleep quality assessment [ Time Frame: Every 12 months, up to 10 years. ]
   PSQI (Pittsburgh Sleep Quality Index). Tool designed to evaluate sleep quality over a 1 month interval. Scoring 0-21 points. Any score >5 indicates sleep impairment, with higher scores designating poorer sleep and greater impact on daily life.
6. Cancer prevalence [ Time Frame: Every 12 months, up to 10 years. ]
   Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.
7. Chronic disease prevalence [ Time Frame: Every 12 months, up to 10 years. ]
   Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women 18 years and older
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

• Women only
• Age 18 years and older.
• Must be willing to complete an online program
• Follow the dietary guidelines as outlined to the best of their ability.
• English-speaking
• US residents
• Have internet access
• Pregnant women are eligible

Exclusion criteria:

• None

Contacts and Locations

Locations

United States, Arizona

Northern Arizona University

Flagstaff, Arizona, United States, 86011

Sponsors and Collaborators

Northern Arizona University

Investigators

• Principal Investigator: Jay Sutliffe; Northern Arizona University

More Information

Publications of Results:

Sutliffe JT, Fuhrman JH, Carnot MJ, Beetham RM, Peddy MS. Nutrient-dense, Plant-rich Dietary Intervention Effective at Reducing Cardiovascular Disease Risk Factors for Worksites: A Pilot Study. Altern Ther Health Med. 2016 Sep;22(5):32-6.

Sarter B. Effect of a high nutrient density diet on long-term weight loss: a retrospective chart review. Altern Ther Health Med. 2011 Nov-Dec;17(6):10; author reply 10.

Jenkins DJ, Kendall CW, Faulkner DA, Nguyen T, Kemp T, Marchie A, Wong JM, de Souza R, Emam A, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am J Clin Nutr. 2006 Mar;83(3):582-91.

Yokoyama Y, Barnard ND, Levin SM, Watanabe M. Vegetarian diets and glycemic control in diabetes: a systematic review and meta-analysis. Cardiovasc Diagn Ther. 2014 Oct;4(5):373-82. doi: 10.3978/j.issn.2223-3652.2014.10.04.

Sutliffe JT, Wilson LD, de Heer HD, Foster RL, Carnot MJ. C-reactive protein response to a vegan lifestyle intervention. Complement Ther Med. 2015 Feb;23(1):32-7. doi: 10.1016/j.ctim.2014.11.001. Epub 2014 Dec 3.

Fuhrman J, Sarter B, Glaser D, Acocella S. Changing perceptions of hunger on a high nutrient density diet. Nutr J. 2010 Nov 7;9:51. doi: 10.1186/1475-2891-9-51.

Gonzales JF, Barnard ND, Jenkins DJ, Lanou AJ, Davis B, Saxe G, Levin S. Applying the precautionary principle to nutrition and cancer. J Am Coll Nutr. 2014;33(3):239-46. doi: 10.1080/07315724.2013.866527. Epub 2014 May 28. Review.

Tucker KL, Hallfrisch J, Qiao N, Muller D, Andres R, Fleg JL; Baltimore Longitudinal Study of Aging. The combination of high fruit and vegetable and low saturated fat intakes is more protective against mortality in aging men than is either alone: the Baltimore Longitudinal Study of Aging. J Nutr. 2005 Mar;135(3):556-61.

• Responsible Party: Jay Sutliffe, Associate Professor, Northern Arizona University
• ClinicalTrials.gov Identifier: NCT03430141
• Other Study ID Numbers: Nutritarian Women's Study
• First Posted: February 12, 2018
• Last Update Posted: September 22, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We are considering making this data available to other researchers after we have a substantial number of participants enrolled.
• Supporting Materials: Study Protocol; Clinical Study Report (CSR)
• Time Frame: Open October 31, 2016. Closed December 31. 2019.
• Access Criteria: please contact study office at nwhs@nau.edu for information

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cardiovascular Diseases; Metabolic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes