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The Effects of Whey Based and Fruit and Vegetable Based Dietary Supplements on Blood Pressure and Heart Rate Variability John Q. Zhang, MD, PhD, L.AC John Maher, DC Associate Director of Research Logan College of Chiropractic John.zhang@logan.edu March 13, 2009

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slide1

The Effects of Whey Based and Fruit and Vegetable Based Dietary Supplements on Blood Pressure and Heart Rate Variability

John Q. Zhang, MD, PhD, L.AC

John Maher, DC

Associate Director of Research

Logan College of Chiropractic

John.zhang@logan.edu

March 13, 2009

introduction zoo phytonutrients
Introduction- Zoo & Phytonutrients

The purpose of this study was to determine the effect of zoonutrient (whey based) and phytonutrient (fruit and vegetable based) nutritional supplementation on the reduction of blood pressure and improving heart rate variability in pre-hypertensive and hypertensive subjects.

introduction definitions
Introduction- Definitions
  • Phytonutrients are generally non-essential micronutrients found in plant foods that nonetheless have a salubrious effect on human health and physiology. Examples include EGCG, resveratrol, lutein and chlorophyll.
  • Zoonutrients are similar except that they are sourced from animal foods. Examples include peptides, globulins, enzymes.
introduction diet supps
Introduction- Diet & Supps
  • In a study with five hundred men and women consuming a strictly vegetarian diet for 12 days living at a hospital based health center, the authors reported a rapid reduction in blood pressure of 6% and a weight loss of 2.5 kg for men and 1 kg for women.1
  • Recent studies on nutritional supplementation have also found consistent reduction of blood pressure in subjects with elevated blood pressure.2-19
introduction non rx interventions
Introduction: Non-Rx Interventions
  • A recent meta-analysis of clinical nutritional and lifestyle changes evaluated the effects of numerous interventions on systolic BP .
  • The most effective intervention was the DASH diet followed by exercise, weight loss, sodium restriction and fish oil supplements.
  • The least effective were increased intake of magnesium, calcium and potassium, or reduction in alcohol intake.
introduction whole food
Introduction: Whole Food
  • This meta-analysis and other nutritional/diet studies emphasize the importance of the additive or synergistic effect of multiple nutrients, whole food and whole food concentrates with their nutrient combinations in a natural complex form to reduce BP and CVD.20
introduction dairy peptides
Introduction-DairyPeptides
  • Studies on infants showed that di- and tri-peptides are easily absorbed in the intestine.
  • The antihypertensive peptides from sour milk have shown to be absorbed in the digestive system.
  • The functional component may include various lactic acid bacteria (Lactobacillus GG and Lactococcus lactis) that have been shown to hydrolyze milk proteins into bioactive peptides21
introduction peptides
Introduction- peptides

Various studies have found that whey-derived

Peptides:

  • may reduce blood pressure and indirectly impart coronary health.
  • have antioxidant activity, which improves overall cardiovascular health.
  • demonstrated activity in reducing dyslipidemia as well as blood pressure.
  • have been demonstrated efficacious in animal researches, but trials on human subjects are limited.22
introduction mechanism
Introduction- Mechanism

The mechanism of the bioactive whey

peptides may be involved in:

  • ACE inhibitory activity,
  • opioid-like activity,
  • anti-thrombotic activity and
  • cholesterol-reducing activity.23
introduction wzp
Introduction (WZP)
  • To test the potential of these bioactive peptides, this study tested NanoProPRP which is a powdered drink mix made with antibiotic free, undenatured whey protein isolate (WPI) and colostrums from BovineSpongiform Encephalopathy (BSE) free herds not treated with growth hormone or hyper-immunization, or feed animal by-products.
  • As it is hypothesized that the zoonutrients (peptides, opiates, microflora) are the likely active ingredients as relates to hypertension, going forward we will use the designation WZP for Whey Zoonutrient Powder.
introduction wzp11
Introduction- WZP
  • WZP* is uniquely fortified with colostrum and proline rich polypeptides (PRP), considered colostrum’s most powerful immune modulating peptides, along with organic selenium, reduced glutathione (protected in a liposome) and inulin.

* The ingredients and supplemental facts can be found on the NanoProPRP canister, on BioPharma’s product literature and the company website, www.biopharmasci.com.

introduction fruits veggies
Introduction- Fruits & Veggies
  • Fruits and vegetables (F&V) are a rich source of a number of essential micronutrients and phytonutrients having antioxidant properties.
  • Generally, fruits and vegetables in the raw state have significantly higher values as an antioxidant than the cooked state.24
  • However, most Americans do not consume the recommended 7-9ervings of fruits and vegetables a day, cooked or raw. 25
  • Increasingly, according to NBJ, more first world peoples take a daily fruit and/or vegetable phytonutrient supplement.
introduction gpp
Introduction- (GPP)
  • In this study we used Biopharma’s supplement, NanoGreens10*, a high antioxidant powdered drink mix composed of greens, fruits, vegetables, plus a few teas, herbs and spices, that incorporated a liposome delivery purported to assist bioavailability.
  • Going forward we will refer to this formula as GPP, green phytonutrient powder.
  • The ingredients and supplemental facts can be found on the NanoGreens10 canister, on BioPharma’s product literature and the company website, www.biopharmasci.com.
previous study gpp
Previous Study*- GPP
  • Results: “After taking the supplement for 90 days, both the systolic and diastolic blood pressure decreased significantly.”
  • The systolic blood pressure decreased from 140.4±17.7 mmHg to 128±14.2 mmHg, (12.4 mmHg) and
  • the diastolic blood pressure decreased from 90.2±7.7 mmHg to 83.1±7.4 mmHg (7.1 mmHg).20
introduction mechanisms
Introduction- Mechanisms

The particular mechanism of the beneficial effects of

taking a F&V supplement is not well established.

  • It has been hypothesized that phytonutrients might serve as antagonists on the aryl hydrocarbon receptor (AhR) ( an inhibitor of brady kinnin, a vasodialator),26
  • provide nitrates for NO production27
  • act as quenchers of reactive oxygen species (ROS) thereby favorably effecting the vascular endothelium via their antioxidant actions.28
introduction aims
Introduction- Aims
  • In this study, the two specific types of supplement drink powder mixes (WZP & GPP) were tested to document their effects on cardiovascular system.
  • The specific aims of the study were to study the effectiveness of both of the above described zoonutrient (WZP) and phytonutrient (GPP) powdered drink mixes on blood pressure (BP) and heart rate variability (HRV), compared to a control group (CG).
the hypotheses
The Hypotheses

1) that the whey based supplement (WZP) would be effective in reducing blood pressure and increasing HRV comparing to control group (CG).

2) that the combined whey based and fruit and vegetable based supplements (WZP + GPP) would be even more effective than whey alone.

methods of subjects
Methods- # of Subjects
  • With an expected drop-out rate of 10 percent, this study would require approximately 57 subjects at completion. 
  • For the study to have sufficient power of 0.90, with a 95% confidence interval (p = 0.05), a minimum of 54 students (18 in each group) were needed to complete this study.
methods random selection
Methods- Random Selection
  • Subjects were assigned into one control and two experimental groups by random numbers.
  • The first 60 numbers in the first two rows of the random table were used for the study.
  • Subjects with the lowest 20 numbers were assigned in the control group, the highest 20 in the experimental group and the middle 20 in the second experimental group.
  • A total of three groups of subjects were recruited in the study.
methods three groups
Methods- Three Groups
  • The first group of subjects was the control group consuming 500 mg calcium per day.
  • The second group took 2 servings (36 gm) of WZP a day.
  • The third group took 2 servings each of WZP(36 gm) and GPP (24 gm) products.
  • All subjects were giving a three months supply of the nutritional supplement free of charge.*
  • The supplement was provided by Biopharma Scientific, Inc., 5375 Sorrento Pl, Solana Beach, CA 92075.
methods inclusion exclusion
Methods- Inclusion /Exclusion
  • Inclusion Criteria: Male or female hypertensive subjects 30-55 years old with systolic blood pressure between 130-160 mmHg, and diastolic blood pressure of 80-105 mmHg were recruited in the study.
  • Exclusion Criteria: Individuals with diabetes, heart, kidney, thyroid disorders, neurological diseases, and chronic disease were not recruited in the study. Female subjects who were pregnant or breast feeding were excluded. Those using drugs or medications were not permitted to participate in the study.
methods measurements
Methods- measurements
  • A Biopac manual blood pressure monitor (Biopac, Santa Barbara, CA, 93117) was used in the blood pressure measurements.
  • All blood pressure measurements were taken twice and an average value was used in the data analysis.
  • Researchers taking the blood pressure measurements had training in blood pressure measurements and at least one year of experience in hypertension studies.
  • Body weight was taken with the six-way weight scale (Chirotron). Only the total body weight was used in the study.
methods measurements25
Methods-Measurements
  • Heart rate variability (HRV): Biocom’s Active ECG Scanner was used in the HRV data collection with digital signal processing software.
  • The Heart Scanner records an electrocardiograph (ECG) signal, computing the instantaneous changes of HRV after each recording session. The Scanner connects to the subjects through three small electrodes that attach to the left arm, right arm and left leg.
methods hrv
Methods- HRV
  • A baseline HRV was recorded before treatment was given.
  • The HRV recording was taken in the sitting position for 5 minutes for all subjects.
  • No additional gels were needed for the electrodes. Special care was given to clean the skin surface to improve skin conductance.
methods statistics
Methods- Statistics
  • Repeated measurements, using ANOVA analysis*, assessed the differences of nutritional supplements on blood pressure, body weight and HRV.
  • SigmaStat 3.5 statistical software was used for the data analysis. Significance was determined at p 0.05
  • In statistics, analysis of variance (ANOVA) is a collection of statistical models, and their associated procedures, in which the observed variance is partitioned into components due to different explanatory variables.
results recruitment
Results-Recruitment
  • Thirty-seven subjects (6 female) were recruited and thirty-two (5 female) completed the study.
  • The study initially designed to recruit 57 subjects to satisfy the power requirement to reach statistically significant difference.
  • It was noted in an early data analysis that the data had reached statistically significant level.
  • Further data collection will be based on participants’ interests in the study.
results three groups
Results- Three Groups
  • The average age of the subjects was 24.54.4 years old in the three groups.
  • All three groups had similar baseline characteristics in age, gender, blood pressure and HRV.
  • Control group (CG) has 11 subjects (3 female), WZP group had 12 subjects (2 female) and WZP + GPP had 9 subjects (0 female).
results bp
Results-BP
  • After taking the supplement for 90 days, both the systolic and diastolic blood pressure decreased significantly in the WZP and WZP + GPP (Figure 1, 2).
  • No significant changes were observed in the CG (Figure 1, 2).
  • The systolic blood pressure decreased from 141.0±11.8 mmHg to 126.6±7.2 mmHg (P<0.05) and the diastolic blood pressure decreased from 92.8±6.2 mmHg to 84.6±9.4 mmHg (P<0.05) in the WZP. (13.4/8.2)
results bp31
Results-BP
  • The systolic blood pressure decreased from 136.3±3.1 mmHg to 125.4±5.1 mmHg (P<0.05) and the diastolic blood pressure decreased from 88.5±7.6 mmHg to 74.6±7.7 (P<0.05) mmHg in the WZP + GPP. (10.9/13.9)
  • In the CG group systolic blood pressure measured at 139.7±14.2 to 137.9±19.0 mmHg and the diastolic blood pressure from 89.8±6.9 to 87.0±7.7 mmHg) (P>0.05).
results weight hrv
Results-Weight & HRV
  • After taking the supplement for 90 days, body weight was increased significantly in CG control group from 190.9±20.9 pounds to 196.3±23.3 (P<0.05).
  • The body weight in the WZP and WZP + GPP group did not show significant changes (P>0.05).
  • The heart rate and the heart rate variability analysis did not show any significant changes.
slide33

Figure 1. Systolic blood pressure changes after taking the WZP and

the WZP +GPP compared to the CG ( 500 mg Ca++ pills).

180

160

140

CG

Blood Pressure (mmHg)

120

WZP

WZP + GPP

100

80

60

Day 0

Day 45

Day 90

slide34

Figure 2. Diastolic blood pressure changes after taking the WZP and WZP +GPP

compared to the CG ( 500 mg Ca++ pills).

110

90

CG

Blood Pressure (mmHg)

WZP

WZP + GPP

70

Day 0

Day 45

Day 90

50

summary
Summary
  • After taking the WZP and WZP+ GPP powdered drink mix supplements for 90 days, both the systolic and diastolic blood pressures decreased significantly.
  • The body weight was increased in the control group but not in the two treatment groups.
  • HRV was not affected
discussion
Discussion
  • The results mimic the published efficacy of the most successful dietary intervention, the Dietary Approach to Stop Hypertension + low sodium combined! (D.A.S.H II diet). (11.4/6.8.5)
  • The results mimic the efficacy of any one common prescription medication.(12/6)
  • The results mimic the efficacy of pilot studies on GPP alone 29-31
jama rx study 32 http jama ama assn org cgi content full 288 23 2981 figjoc21962f2
JAMA Rx Study32 http://jama.ama-assn.org/cgi/content/full/288/23/2981/FIGJOC21962F2
discussion further studies
Discussion- Further Studies
  • However, as sample size is small, particularly in this present study, further human trials on larger and more diverse population of persons with pre-hypertension and hypertension are needed.
references
References
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  • Rouse IL, Beilin LJ, Armstrong BK, Vandongen R. Blood-pressure-lowering effect of a vegetarian diet: controlled trial in normotensive subjects. Lancet 1983;1:5-10.
  • Margetts BM, Beilin LJ, Vandongen R, Armstrong BK. Vegetarian diet in mild hypertension: randomized controlled trial. Br Med J 1986;293:1468-71.
  • Appel LJ, Moore TJ, Obarzanek E, et al. A clinical trial of the effects of dietary patterns on blood pressure. N Engl J Med 1997;336:1117-24.
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references40
References
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  • Sauvaget C, Nagano J, Allen N, Kodama K. Vegetable and fruit intake and stroke mortality in the Hiroshima/Nagasaki Life Span Study. Stroke. 2003 Oct;34(10):2355-60. Epub 2003 Sep 18.
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  • Mark C. Houston, MD, SCH, FACP, FAHA, The Role of Vascular Biology, Nutrition, and Nutraceuticals in the Prevention and Treatment of Hypertension., JANA April 2002, Supplement No. 1 p. 5
  • Shortt C, O'Brien. Formation of Bioactive Peptides During Milk Fermentation, Handbook of Functional Dairy Products. CRC Press, 2003, pp 113-117 (http://books.google.com/books?id=geXneTZ13w4C)
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  • Ibid. 22, pp 985S-86S
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  • Ibid. 20, p.35
  • Ibid. 20, p. 20
  • Magill Mk, Gunning K, Saffel-Shrier S, Gay C. New Developments in the Management of Hypertension, American Family Physician, Vol. 68, No. 5, pp 853-864 2001 http://www.aafp.org/afp/20030901/853.html23.
  • Zhang J, Oxinos G, Maher J. The Effect of Fruit and Vegetable Powder Mix on Hypertensive Subjects, Journal of Chiropractic Education, Spring 2007, Vol. 21 No. 1, p 93
  • Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), JAMA, Vol. 288 No. 23, December 18, 2002 http://jama.ama-assn.org/cgi/content/full/288/23/2981/FIGJOC21962F2