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

Cancer Clinical Trial

— NWHS  

Official title:

Nutritarian Women's Health Study to Reduce Chronic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430141
• Other study ID #: Nutritarian Women's Study
• Status: Completed
• Phase: N/A
• Start date: October 31, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Northern Arizona University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2898
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Chronic Disease
• Diabetes Mellitus
• Lifestyle-related Condition
• Mental Health Wellness 1
• Metabolic Diseases
• Nutrition Related Cancer
• Nutritional and Metabolic Disease
• Nutritional Imbalance
• Sleep
• Thyroid

Intervention

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.

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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 choles — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Balt — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight Management	Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m^2.	Every 12 months, up to 10 years.
Secondary	Waist Measurement	Self-measured and reported measurements in inches.	Every 12 months, up to 10 years.
Secondary	Hip Measurement	Self-measured and reported measurements in inches.	Every 12 months, up to 10 years.
Secondary	Mental Health	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).	Every 12 months, up to 10 years.
Secondary	Sleep quality assessment	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.	Every 12 months, up to 10 years.
Secondary	Cancer prevalence	Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.	Every 12 months, up to 10 years.
Secondary	Chronic disease prevalence	Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population.	Every 12 months, up to 10 years.