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CURRENT ISSUES IN CLINICAL NUTRITION Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest Selected Topics Vitamin, mineral and fish oil supplements Low-fat diets Diet and lipid disorders Diet, exercise and weight loss Case 1 53 year old woman in for check up. In good health. Exercises regularly. Eats low fat diet. Grandmother had hip fracture at age 86. Father with MI age 72. On no meds, but takes multivitamin and calcium daily. BMI 26. BP normal. LDL <100. What advice should you give about her diet and supplements? CALCIUM, VITAMIN D AND FRACTURES 36,282 postmenopausal women, 50-79 Randomized to 1000 mg calcium plus 400 IU of vitamin D vs placebo, 7 year f/u. Placebo 199 Hazard Ratio 0.88 (0.72-1.08) 181 197 0.90 (0.74-1.10) Arm/wrist 565 557 1.01 (0.90-1.14) Total 2158 0.96 (0.91-1.02) Hip Calcium/D 175 Vertebral 2102 Jackson, NEJM 2006 CALCIUM, VITAMIN D AND INVASIVE COLON CANCER 36,282 postmenopausal women, 50-79 Randomized to 1000 mg calcium plus 400 IU of vitamin D vs placebo, 7 year f/u. Calcium/D Cancer 168 Placebo 154 Hazard Ratio 1.08 (0.86-1.34) Wactawski-Wende, NEJM 2006 LOW-FAT DIET AND INVASIVE BREAST CANCER 48,835 postmenopausal women, 50-79 Randomized to dietary intervention or comparison Intervention: reduce total fat to 20% of energy and increase fruits and vegetables to at least 6 servings per day; 8.1 year f/u. Intervention Year 1 Comparison Year 1 Difference Between Groups Year 3 Year 6 Fat 24.3% 35.1% -9.5% -8.1% Calories 1500 kcals 1594 kcals -93 -119.9 F and V 5.1 servings 3.9 servings +1.3 +1.1 Weight 74.4 kg 76.3 kg -1.3kg -0.8kg Prentice, NEJM 2006 LOW-FAT DIET AND INVASIVE BREAST CANCER (Cases, annualized per cent) Intervention Comparison HR p Breast Cancer Incidence Mortality 0.42 0.02 0.45 0.02 0.91 (0.83-1.01) 0.77 (0.48-1.22) .09 .27 Total Cancer Incidence Mortality 1.23 0.28 1.28 0.29 0.96 (0.91-1.02) 0.95 (0.84-1.07 .10 .22 0.60 0.61 Total mortality 0.98 (0.91-1.07) Prentice, NEJM 2006 .29 LOW-FAT DIET AND INVASIVE COLON CANCER Time, y Beresford, S. A. A. et al. JAMA 2006;295:643-654. LOW-FAT DIET AND CARDIOVASCULAR DISEASE All Participants Time, y Participants Without a History of CVD Time, y Howard, B. V. et al. JAMA 2006;295:655-666. LOW-FAT DIET AND WEIGHT CHANGE Overall Howard, B. V. et al. JAMA 2006;295:39-49. Case 2 63 year old man, with CAD, s/p angioplasty with stent placement, feels well, in for check up. Meds include ASA, beta blocker, ACE, statin, thiazide, vitamin E, beta-carotene. He asks whether he should start B vitamins and fish oil. VITAMIN E AND CARDIOVASCULAR DISEASE Vitamin E vs placebo 7 RCTs; 106,625 subjects Vit E Placebo CV event 4832 CV death 2683 MI 1255 Stroke 742 4895 2689 1254 723 NS NS NS NS Eidelman, JAMA, 2004 VITAMIN E, CARDIOVASCULAR EVENTS AND CANCER: HOPE TOO 3994 subjects, >55, vascular disease or diabetes Randomized to 400 IU vitamin E, or placebo, 7 year f/u Vitamin E Cancer 552 Cancer deaths 156 CV events 1022 Heart failure Hosp for CHF 641 236 Placebo 586 178 985 p .30 .24 .34 578 196 .03 .045 Hope and Hope-TOO Investigators, JAMA, 2005 VITAMIN E AND CARDIOVASCULAR DISEASE AND CANCER Women’s Health Study, Vitamin E 600 IU QOD vs placebo 39,876 subjects, over 45 years old, 10.1 yrs f/u Vitamin E CV event 482 MI 196 Stroke 241 CV deaths 106 Placebo 517 195 246 140 p 0.26 0.96 0.82 0.03 Invasive cancer 1437 1428 0.87 Total mortality 636 615 0.53 Lee, JAMA, 2006 Beta-CAROTENE AND CARDIOVASCULAR DISEASE Beta-carotene vs placebo 8 RCTs; 138,113 subjects Mortality Carotene 7.3% Placebo NNH* CV death 3.3% Stroke 2.4% 7.0% 3.1% 2.3% 326 409 NS * number needed to harm Vivekananthan, Lancet, 2003 FOLATE AND RESTENOSIS AFTER STENTING 636 patients, post stent Randomized to folic acid, B6 and B12 vs placebo, 6 month f/u B vitamins Placebo Restenosis 35.5% Lumen 1.59mm Revasc 15.8% 26.5% 1.74mm 10.6% p=0.05 p=0.008 p=0.05 Lange, NEJM, 2004 VITAMIN INTERVENTION FOR STROKE PREVENTION (VISP) 3680 adults, s/p stroke Randomized to: Mulitivit with low dose B6, B12, folic acid Multivit with high dose B6, B12, folic acid Low dose Stroke 148 CHD 123 Death 117 High dose 152 114 99 p=0.80 p=0.57 Combined 316 p=0.25 Toole, JAMA, 2004 303 p=0.61 HOMOCYSTEINE LOWERING AND CARDIOVASCULAR EVENTS (NORVIT) 3749 men and women post MI Folic acid (0.8 mg), B12 (0.4 mg), and B6 (40 mg) vs. placebo; 2 X2 factorial design; 40 month f/u B Vitamins/Placebo 1.22 p 0.05 MI 1.23 0.06 Stroke 0.83 0.52 Cancer 1.02 0.94 Total mortality 1.21 0.19 Combined events Bonaa, NEJM, 2006 HOMOCYSTEINE LOWERING AND CARDIOVASCULAR EVENTS (HOPE 2) 5522 men and women with vascular disease or diabetes 55 and older; 5 year f/u Folic acid (2.5 mg), B12 (1 mg), and B6 (50 mg) vs. placebo B Vitamins/Placebo RR p 0.95 0.41 CV Death 0.96 0.59 MI 0.98 0.82 Stroke 0.75 0.03 0.99 0.94 Combined events Total mortality HOPE 2, NEJM, 2006 FISH OIL AND SUDDEN DEATH Background: Observational data (Eskimos) and 4 RCTs suggest reduced sudden death with fish oils (diet or supplement) RCT, 200 patients with implantable defibrillators, fish oil 1.8g vs placebo, for two years Raitt, JAMA, 2005 Time to First Episode of ICD Therapy by Fish Oil vs Placebo Group Raitt, JAMA 2005 OMEGA-3 FATTY ACIDS AND CANCER Systematic review of 38 studies 20 cohorts, 11 types of cancers: Breast: 1 increased, 3 decreased, 7 no association Colon: 1 decreased, 17 no association Lung: 1 increased, I decreased, 4 no association Prostate: 1 decreased, 15 no association Skin: 1 increased Aerodigestive, bladder, lymphoma, ovarian, pacreatic, and stomach: no association MacLean, JAMA, 2006 Case 2 63 year old man, with CAD, in for check up. Plan: DC vitamin E and carotene Defer B vitamins and fish oil Reinforce use of current meds, diet (including fish) and exercise Case 3 53 year old woman, in good health, in for check up. No cardiovascular risk factors. Body mass index is 26. BP 110/70. LDLcholesterol is 170, HDL-cholesterol is 55, triglycerides 100. She exercises 5 days per week. Follows low fat, low cholesterol, mostly natural food diet. Framingham risk score 1% risk of CV event in next 10 years How should we manage her LDL? LDL Goal and Cutpoints Patients with 0–1 Risk Factor 2001 and 2004 LDL Level at Which to Initiate Diet LDL Goal <160 mg/dL 160 mg/dL LDL Level at Which to Consider Drug Therapy 190 mg/dL (160–189 mg/dL: LDL-lowering drug optional) Therapeutic Lifestyle Changes (TLC): Major features • TLC Diet – Reduced intake of cholesterol-raising nutrients • Saturated fats <7% of total calories • Dietary cholesterol <200 mg per day – LDL-lowering therapeutic options • Plant stanols/sterols (2 g per day) • Soluble fiber (10–25 g per day) • Weight reduction • Increased physical activity ATP III, NCEP 2001 TLC for patients with LDL-C = 160 Dietary Component LDL-C (mg/dL) Low saturated fat/dietary cholesterol –12 Viscous fiber (10–25 g/d) –8 Plant stanols/sterols (2 g/d) Total –16 –36 mg/dl EFFECT OF A PLANT-BASED DIET • 120 patients, LDL 130 - 190, 4 weeks • Low fat vs. low fat plus • Equivalent macronutrients • Low-fat plus had more vegetables, legumes, whole grains Gardner, Ann Intern Med, 2005 EFFECT OF PLANT-BASED DIET LDL mg/dl Low fat Low fat plus -7.0 -13.8 Conclusion: current guidelines may underestimate potential LDL-lowering effect Gardner, Ann Intern Med, 2005 Cholesterol-Lowering Foods vs Lovastatin 46 volunteers with hyperlipidemia, 1 month study, foods provided Randomized to control diet vs control diet and lovastatin vs “dietary portfolio” Control diet: vegetarian, very low in saturated fat, whole wheat cereals, low fat dairy foods “Portfolio” diet: also very low saturated fat, vegetarian diet, plus high in plant sterols, soy protein, soluble fibers, almonds Jenkins, Am J Clin Nutr, 2005 DIETARY PORTFOLIO Breakfast: Oat bran cereal, soy beverage, strawberries, sugar and psyllium, oat bran bread, enriched margarine (with sterols), fruit jam Snack: Almonds, soy beverage, fresh fruit Lunch: Black bean soup, sandwich (soy deli slices, oat bran bread, enriched margarine, lettuce, tomato, cucumber) Snack: Almonds, psyllium, fresh fruit Dinner: Tofu bake with ratatouille (tofu, eggplant, onions, peppers) Snack: Fresh fruit, psyllium, soy beverage Jenkins, Am J Clin Nutr, 2005 Cholesterol-Lowering Foods vs Lovastatin Control LDL -8.0% CRP -10.0% Control/statin -30.9% -33.3% Portfolio -28.6% -28.2% Jenkins, Am J Clin Nutr, 2005 Case 4 50 year old woman, in good health, in for check up. BMI 32 with metabolic syndrome. She says, “ I have to lose weight, and I am planning on doing that. I am about to try the South Beach diet.” COMPARISON OF ATKINS, ORNISH, WEIGHT WATCHERS, AND ZONE 160 patients, randomly assigned Intention to treat at 1 year Wt Loss (kg) Completers (%) Atkins 2.1 53 Ornish 3.3 50 WW 3.0 65 Zone 3.2 65 Ornish 6.6 WW 4.6 Zone 4.9 Completers at 1 year Wt Loss (kg) Atkins 3.9 Dansinger, JAMA 2005 COMPARISON OF ATKINS, ORNISH, WEIGHT WATCHERS, AND ZONE Each group: 25% lost 5%, 10% lost 10% of initial weight Each diet reduced LDL/HDL by 10% No significant effects on BP or glucose Weight loss associated with adherence, but not diet type CRP and insulin reductions associated with weight loss, but not diet Dansinger, JAMA, 2005 2005 Dietary Guidelines Adequate nutrients within calorie needs: limit saturated and trans fats, cholesterol, added sugars, salt and alcohol Weight management: balance intake and output Physical activity: to reduce risk of disease: 30 min moderate intensity most days to prevent weight gain: 60 minutes to sustain weight loss: 60-90 minutes Food groups encouraged: 2 cups of fruit/day 2.5 cups vegetables/day 3 servings whole grains 3 servings low-fat dairy Dietary Guidelines for Americans, 2005