NCT03430141

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,898

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

3.2 years

First QC Date

August 30, 2017

Last Update Submit

September 18, 2020

Conditions

Chronic DiseaseCancerCardiovascular DiseasesDiabetes MellitusLifestyle-related ConditionMental Health Wellness 1SleepNutritional and Metabolic DiseaseNutrition Related CancerNutritional ImbalanceThyroid

Outcome Measures

Primary Outcomes (1)

  • Nutrition Intervention

    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).

    Every 12 months, up to 10 years.

Secondary Outcomes (7)

  • Weight Management

    Every 12 months, up to 10 years.

  • Waist Measurement

    Every 12 months, up to 10 years.

  • Hip Measurement

    Every 12 months, up to 10 years.

  • Mental Health

    Every 12 months, up to 10 years.

  • Sleep quality assessment

    Every 12 months, up to 10 years.

  • +2 more secondary outcomes

Study Arms (1)

Intervention for all participants

EXPERIMENTAL

Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol.

Other: Nutritarian Diet-style

Interventions

Nutritarian Diet-styleOTHER

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.

Intervention for all participants

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen 18 years and older
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

Related Publications (8)

  • 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.

    PMID: 27622958RESULT

  • 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. No abstract available.

    PMID: 22314713RESULT

  • 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. doi: 10.1093/ajcn.83.3.582.

    PMID: 16522904RESULT

  • 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.

    PMID: 25414824RESULT

  • 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.

    PMID: 25637150RESULT

  • 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.

    PMID: 21054899RESULT

  • 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.

    PMID: 24870117RESULT

  • 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. doi: 10.1093/jn/135.3.556.

    PMID: 15735093RESULT

MeSH Terms

Conditions

Chronic DiseaseNeoplasmsCardiovascular DiseasesDiabetes MellitusMental DisordersMetabolic DiseasesThyroid Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jay Sutliffe

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Hybrid effectiveness-implementation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

February 12, 2018

Study Start

October 31, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

We are considering making this data available to other researchers after we have a substantial number of participants enrolled.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Open October 31, 2016. Closed December 31. 2019.
Access Criteria
please contact study office at nwhs@nau.edu for information

Locations

US(1)