Description
The Ornish diet and lifestyle modification programme combines a supplemented vegan diet with exercise, stress management, and group support sessions.
The programme is claimed to enable patients with early-stage prostate cancer to delay or avoid conventional treatment and/or improve quality of life. However, only one randomized trial and one pilot study have been published, all using surrogate markers for prostate cancer.
In prostate cancer patients, the programme was found to improve cardiovascular health parameters, which is important as cardiovascular disease is the primary or secondary cause of death in men with prostate cancer.
Efficacy
Anticancer treatment
Surrogate biomarkers: One RCT (n=93) reported decreased PSA markers and inhibited growth of LNCaP cells after 1 year in the group following the Ornish programme compared with control group making lifestyle changes only.
Supportive and palliative care
Quality of life: The above-mentioned RCT (n=93) found greater improvements in cardiovascular health parameters in the Ornish group. Overall QoL was improved in both groups and other physical-health related QoL did not differ between groups.
Safety
Trial results to date indicate absence of adverse effects.
Citation
Wider B, Mora D, CAM Cancer Collaboration. Ornish diet and lifestyle modification programme [online document], Oct 24, 2023
Document history
Latest update: Revised and updated by Dana Mora and Barbara Wider in October 2023. Assessed as up to date in January 2021 and January 2019, by Barbara Wider. Revised and updated in January 2012 and January 2017, by Luc Geeraert. First published in 2011, authored by Luc Geeraert. Next update due: October 2026
Description
The Ornish diet and lifestyle modification programme combines a supplemented vegan diet with exercise, stress management, smoking cessation, and group support sessions (Ornish 2005). It is mainly aimed at preventing heart disease.
Dean Ornish MD, is founder and president of the non-profit Preventive Medicine Research Institute in Sausalito, California, and clinical professor of medicine at the University of California, San Francisco (OLM 2023). In his popular book entitled “The Spectrum”, Ornish provides examples of various individually tailored diet and lifestyle programmes, including one to prevent/reverse certain types of prostate and breast cancer (Ornish 2007). These programmes have been further developed and are described on his Ornish Lifestyle Medicine™ website.
Background and prevalence
Dean Ornish MD, is founder and president of the non-profit Preventive Medicine Research Institute in Sausalito, California, and clinical professor of medicine at the University of California, San Francisco (OLM 2023). In his popular book entitled “The Spectrum”, Ornish provides examples of various individually tailored diet and lifestyle programmes, including one to prevent/reverse certain types of prostate and breast cancer (Ornish 2007). These programmes have been further developed and are described on his Ornish Lifestyle Medicine™ website.
No prevalence data are available.
Alleged indications
The earlier work of Ornish and colleagues in the 1980s and 1990s demonstrated that diet, lifestyle changes, and smoking cessation could not only halt the progression of ischemic heart disease, but could actually reverse it (Ornish 1991, Ornish 1983, Ornish 1998). Given that cardiovascular disease is the primary or secondary cause of death in men with prostate cancer, (Luo 2023) and that a large number of epidemiological and laboratory studies suggested that diet and lifestyle may play an important role in the development of prostate cancer, the Ornish group began exploring the possible effects of such an intervention in the late 1990s (Ornish 2005; Ornish 2001).
The programme is indicated for early-stage prostate cancer patients (biopsy-documented; Gleason score less than 7; serum prostate-specific antigen (PSA) levels of 4-10 ng/ml; Stages T1 and T2) before surgical intervention or hormone-deprivation, i.e. patients on active surveillance (watchful waiting) closely monitoring disease progress (Ornish 2008a, Cooperberg 2007, Klotz, 2020).
Ornish and colleagues (Ornish 2005, Ornish 2001, Daubenmier 2006, Frattaroli 2008), suggest the possibility that some or all aspects of the combined lifestyle changes (diet + exercise + stress management) enable patients with early-stage prostate cancer to delay or avoid conventional treatment and/or improve quality of life.
Mechanisms of action
The mechanism of action of the Ornish diet and lifestyle modification programme was examined in one prospective pilot study that enrolled 31 low-risk prostate cancer patients (Ornish 2008a, Ornish 2008b, Ornish 2013).
Differences in RNA samples from needle biopsies taken from normal prostate tissue before intervention compared to RNA samples taken after 3 months of intervention indicated that application of the Ornish diet and lifestyle modification programme may modulate gene expression in the prostate (Ornish 2008b). Pathway analysis identified significant modulation of biological processes playing critical roles in tumorigenesis, including protein metabolism and modification, intracellular protein traffic, and protein phosphorylation.
In peripheral blood mononuclear cells (PBMCs) of the patients, telomerase activity and hence telomere maintenance capacity was significantly increased (Ornish 2008b). A 5-year follow study including 10 men compared with 25 external controls, the relative telomere length had increased in the intervention group and decreased in the control group; the difference between both groups was significant (Ornish 2013).
Application and providers
The vegan diet itself is very low in fat: less than 10% of calories comes from fat which occurs naturally in grains, vegetables, fruit, beans, legumes, soy foods and small amounts of nuts and seeds. It is also low in simple carbohydrates, but high in fibre, and includes predominantly fruits, vegetables, whole grains, and legumes, all in their natural unrefined forms. (Ornish 2005) Meat, plant foods high in fat (e.g., avocados), fat dairy products, and refined carbohydrates are eliminated. Consumption of minimal amounts of non-fat dairy products such as skimmed milk, non-fat yoghurt, and non-fat cheese is allowed. The programme recommends a low-dose multivitamin and mineral supplement with B-12 (without iron, if not of childbearing age), fish oil and, possibly upon the advice of a physician, calcium supplements. Sugar and alcohol are allowed in small amounts but not encouraged. (OLM 2023) The diet is in general concordance with the American Cancer Society guidelines. (Rock 2012)
The exercise part consists of regular moderate aerobic exercise (Ornish 2005). Participants are encouraged to exercise aerobically a minimum of 30 minutes a day or for an hour every other day for a total of 3-5 hours of aerobic exercise per week. If medically appropriate, participants are also encouraged to engage in strength training exercise 2-3 times per week. (OLM 2023)
Stress management includes yoga-based stretching, breathing, meditation, imagery, and progressive relaxation (1 hour per day) (Ornish 2005).
Group support sessions (1 hour per week) are included to support adherence to lifestyle changes (Ornish 2005).
Legal issues
According to the Ornish Lifestyle Medicine™ website, the programme is reimbursed for heart disease by some health insurance companies in the US The diet itself is considered inexpensive as it only concerns common food sources and a few supplements.
Only one randomized controlled trial (Ornish 2005, Ornish 2008) and a small a small uncontrolled pilot (described under “Mechanisms of action”, Ornish 2008, Ornish 2013) have been carried out to date. These investigations are limited by reliance on surrogate biomarkers (PSA, PSA doubling time, and serum-induced changes in growth and apoptosis of LNCaP prostate cancer cells), sample size, and duration. To determine the clinical relevance of the findings from these studies on disease-specific survival, and to help define optimal dietary patterns and lifestyle factors important for prostate cancer management, larger, well-designed, and longer-term studies are needed.
Description of included studies
Anticancer treatment
The Ornish diet and lifestyle modification programme was tested in a randomized trial in 93 men with early biopsy-proven prostate cancer (PSA 4-10 ng/ml, Gleason scores less than 7) who had chosen not to undergo any conventional treatment (Ornish 2005). After one year, intensive lifestyle changes resulted in a PSA decrease of 4% and an inhibition of the serum-stimulated growth of LNCaP cells of 70%, compared to a 6% increase of PSA and only 9% LNCaP growth inhibition in the control group which was not following the Ornish diet and lifestyle modification programme, but making lifestyle changes as advised by their physician. None of the 44 patients in the treatment group, but 6 of the 49 control patients had to undergo conventional treatment (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy) due to an increase in PSA and/or progression of disease on magnetic resonance imaging. After 2 years, 2 of the 43 experimental patients and 13 of the 49 control patients had undergone conventional prostate cancer treatment; at this time point no significant differences in PSA change were found between the experimental and control patients (excluding patients who had undergone conventional treatment), and adherence to the intensive lifestyle changes remained high (95%) (Frattaroli 2008).
Quality of life
The above-mentioned RCT (Ornish 2005) also assessed quality of life and related parameters. Experimental patients showed greater improvements in cardiovascular health parameters than did control patients (Kronenwetter 2005). Patients in both the treatment and the control group who improved their lifestyle showed enhanced physical health-related quality of life and decreased perceived stress after 1 year, but no significant differences in quality of life were found between the groups (Daubenmier 2006).
All recommended dietary reference intakes were met by the intervention, only vitamin D intake was less than adequate (Dunn-Emke 2005). After 1 year, the intake of several dietary constituents that may reduce the risk of many chronic diseases was increased, while the intake of constituents implicated with an increased chronic disease risk was decreased in the intervention group compared to controls (Dewell 2008).
Adverse effects
No adverse effects have been reported in the above-cited studies. Other data are not available.
Contraindications
Food allergies/intolerance to soy, soy products, and fish oils.
Interactions
No interactions have been reported in pilot studies and randomized clinical trials.
Warnings
No warnings have been reported in the literature.
Cooperberg MR, Broering JM, Kantoff PW, Carroll PR. Contemporary trends in low risk prostate cancer: risk assessment and treatment. J. Urol. 2007 September;178(3 Pt 2):S14-S19.
Daubenmier JJ, Weidner G, Marlin R, Crutchfield L, Dunn-Emke S, Chi C, Gao B, Carroll P, Ornish D. Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance. Urology. 2006 January;67(1):125-130.
Dewell A, Weidner G, Sumner MD, Barnard RJ, Marlin RO, Daubenmier JJ, Chi C, Carroll PR, Ornish D. Relationship of dietary protein and soy isoflavones to serum IGF-1 and IGF binding proteins in the Prostate Cancer Lifestyle Trial. Nutr. Cancer. 2007;58(1):35-42.
Dewell A, Weidner G, Sumner MD, Chi CS, Ornish D. A very-low-fat vegan diet increases intake of protective dietary factors and decreases intake of pathogenic dietary factors. J. Am. Diet Assoc. 2008 February;108(2):347-356.
Dunn-Emke SR, Weidner G, Pettengill EB, Marlin RO, Chi C, Ornish DM. Nutrient adequacy of a very low-fat vegan diet. J. Am. Diet Assoc. 2005 September;105(9):1442-1446.
Frattaroli J, Weidner G, Dnistrian AM, Kemp C, Daubenmier JJ, Marlin RO, Crutchfield L, Yglecias L, Carroll PR, Ornish D. Clinical events in prostate cancer lifestyle trial: results from two years of follow-up. Urology. 2008 December;72(6):1319-1323.
Klotz L. Low-risk prostate cancer can and should often be managed with active surveillance and selective delayed intervention. Nat. Clin. Pract. Urol. 2008 January;5(1):2-3.
Kronenwetter C, Weidner G, Pettengill E, Marlin R, Crutchfield L, McCormac P, Raisin CJ, Ornish D. A qualitative analysis of interviews of men with early stage prostate cancer: the Prostate Cancer Lifestyle Trial. Cancer Nurs. 2005 Mar-April;28(2):99-107.
Luo Z, Chi K, Zhao H, et al. Cardiovascular mortality by cancer risk stratification in patients with localized prostate cancer: a SEER-based study. Front Cardiovasc Med. 2023;10:1130691.
OLM, Ornish Lifestyle Medicine™ website. Accessed 24th October 2023.
Ornish D, Scherwitz LW, Doody RS, et al. Effects of stress management
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Ornish D. Can life-style changes reverse coronary atherosclerosis? Hosp. Pract. (Off. Ed.). 1991 May 15;26(5):123-126, 129-132.
Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 December 16;280(23):2001-2007.
Ornish DM, Lee KL, Fair WR, Pettengill EB, Carroll PR. Dietary trial in prostate cancer: Early experience and implications for clinical trial design. Urology. 2001 April;57(4 Suppl 1):200-201.
Ornish D, Weidner G, Fair WR, et al. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol 2005;174(3):1065-1069.
Ornish D. The Spectrum: A Scientifically Proven Program to Feel Better, Live Longer, Lose Weight, and Gain Health. New York: Ballantine Books, 2007.
Ornish D, Magbanua MJ, Weidner G, et al. (2008a) Changes in prostate gene expression in men undergoing an intensive nutrition and lifestyle intervention. Proc. Natl. Acad. Sci. USA. 2008 17;105(24):8369-8374.
Ornish D, Lin J, Daubenmier J, et al. (2008b) Increased telomerase activity and comprehensive lifestyle changes: a pilot study. Lancet Oncol. 2008b;9(11):1048-1057.
Ornish D, Lin J, Chan JM, et al. Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study. Lancet Oncol. 2013;14(11):1112-20.
Rock CL, Doyle C, Demark-Wahnefried W et al. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012;62(4):243-74.
Zeng W, Stason WB, Fournier S, et al. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013 May;165(5):785-92.
