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These nutraceuticals research snapshots are now available online in every issue of Nutraceuticals World online. Here is the January/February line-up of the latest developments.
Nutraceutical: Barley beta-glucan
Indication: Cardiovascular disease (CVD)
Source: American Heart Association meeting, Dallas, TX
Research: Researchers conducted a double-blind, placebo-controlled, five-group parallel study to determine the effects of extracted barley beta-glucan on CVD biomarkers. Treatment groups included either low molecular weight (LMW) or high molecular weight (HMW) beta-glucan at both 3- and 5-gram doses. Treatment delivery was both a ready-to-eat cereal and juice given twice daily throughout the six-week study. One hundred and fifty-five generally healthy hypercholesterolemic (LDL-C 130-190 mg/dL) men (n = 76) and women (n = 79) between the ages of 25-73 who completed a four-week diet phase (modified fat diet) were randomly allocated to one of the four treatment groups or control. Additionally, treatment groups were stratified by metabolic status. Fasted blood samples were collected pre- and post-study. Blood lipids and other CVD biomarkers were determined. Patients in the metabolic stratus also participated in a four-hour mixed meal challenge where measures of insulin metabolism were assessed.
Results: Fasted blood lipids were unchanged in the control group. LDL-C was significantly reduced in all treatment groups: 3 grams LMW, 3 grams HMW, 5 grams LMW and 5 grams HMW. In conclusion, both doses of LMW and HMW extracted barley beta-glucan improved blood lipids over a six-week treatment period.
Source: American Heart Association meeting, Dallas, TX
Research: Researchers conducted a double-blind, placebo-controlled, five-group parallel study to determine the effects of extracted barley beta-glucan on CVD biomarkers. Treatment groups included either low molecular weight (LMW) or high molecular weight (HMW) beta-glucan at both 3- and 5-gram doses. Treatment delivery was both a ready-to-eat cereal and juice given twice daily throughout the six-week study. One hundred and fifty-five generally healthy hypercholesterolemic (LDL-C 130-190 mg/dL) men (n = 76) and women (n = 79) between the ages of 25-73 who completed a four-week diet phase (modified fat diet) were randomly allocated to one of the four treatment groups or control. Additionally, treatment groups were stratified by metabolic status. Fasted blood samples were collected pre- and post-study. Blood lipids and other CVD biomarkers were determined. Patients in the metabolic stratus also participated in a four-hour mixed meal challenge where measures of insulin metabolism were assessed.
Results: Fasted blood lipids were unchanged in the control group. LDL-C was significantly reduced in all treatment groups: 3 grams LMW, 3 grams HMW, 5 grams LMW and 5 grams HMW. In conclusion, both doses of LMW and HMW extracted barley beta-glucan improved blood lipids over a six-week treatment period.
Nutraceutical: Calcium, iron and zinc
Indication: Lung cancer
Source: Epidemiology, November 2005; 16(6):772-9.
Research: In this Massachusetts hospital-based case-control study of 923 patients with lung cancer and 1125 healthy controls, researchers studied the associations between dietary iron, zinc, and calcium intake and the risk of lung cancer. Dietary intake was assessed at the time of recruitment (1992 to 2000) with the use of a 126-item semi-quantitative food-frequency questionnaire. Researchers analyzed the data using multiple logistic regression models adjusting for smoking history and other potential risk factors.
Results: The associations between dietary micronutrients intake and lung cancer risk were stronger among current smokers than among former smokers. When researchers examined intake from supplements as well as diet, associations were similar to those for diet alone. Researchers concluded that dietary iron, zinc and calcium may play an important role in the development of lung cancer, especially among current smokers, but that these results need to be confirmed in large prospective studies.
Source: Epidemiology, November 2005; 16(6):772-9.
Research: In this Massachusetts hospital-based case-control study of 923 patients with lung cancer and 1125 healthy controls, researchers studied the associations between dietary iron, zinc, and calcium intake and the risk of lung cancer. Dietary intake was assessed at the time of recruitment (1992 to 2000) with the use of a 126-item semi-quantitative food-frequency questionnaire. Researchers analyzed the data using multiple logistic regression models adjusting for smoking history and other potential risk factors.
Results: The associations between dietary micronutrients intake and lung cancer risk were stronger among current smokers than among former smokers. When researchers examined intake from supplements as well as diet, associations were similar to those for diet alone. Researchers concluded that dietary iron, zinc and calcium may play an important role in the development of lung cancer, especially among current smokers, but that these results need to be confirmed in large prospective studies.
Nutraceutical: Calcium
Indication: Bone mass in young girls
Source: Am J Clin Nutr, November 2005;82(5):1115-26.
Research: The purpose of this study was to learn how to maximize young girls’ peak bone mass during the rapid growth period of puberty, during which 60% of adult bone mass is accumulated. This placebo-controlled intervention trial randomly assigned 195 healthy girls at Tanner stage I-II, aged 10-12 years, with dietary calcium intakes of less than 900 mg per day to one of four groups: calcium (1000 mg) and vitamin D3 (200 IU); calcium (1000 mg); cheese (1000 mg calcium) and placebo. Researchers measured the effects of calcium supplementation on bone mass and body composition, and analyzed the data using traditional statistics as well as a new model that takes into account the rate of body growth.
Results: According to investigators, using cheese containing 1000 mg of calcium was most effective for the young girls because it appeared to be more beneficial for cortical bone mass accrual than the consumption of tablets containing a similar amount of calcium. The lead investigator in the study pointed out, however, that although the cheese containing 1000 mg of calcium seemed to have a greater effect, once researchers examined growth speed there was no beneficial effect observed for any of the interventions. Researchers pointed out that once you exceed certain levels of dietary calcium intake, it doesn’t matter how much you take.
Source: Am J Clin Nutr, November 2005;82(5):1115-26.
Research: The purpose of this study was to learn how to maximize young girls’ peak bone mass during the rapid growth period of puberty, during which 60% of adult bone mass is accumulated. This placebo-controlled intervention trial randomly assigned 195 healthy girls at Tanner stage I-II, aged 10-12 years, with dietary calcium intakes of less than 900 mg per day to one of four groups: calcium (1000 mg) and vitamin D3 (200 IU); calcium (1000 mg); cheese (1000 mg calcium) and placebo. Researchers measured the effects of calcium supplementation on bone mass and body composition, and analyzed the data using traditional statistics as well as a new model that takes into account the rate of body growth.
Results: According to investigators, using cheese containing 1000 mg of calcium was most effective for the young girls because it appeared to be more beneficial for cortical bone mass accrual than the consumption of tablets containing a similar amount of calcium. The lead investigator in the study pointed out, however, that although the cheese containing 1000 mg of calcium seemed to have a greater effect, once researchers examined growth speed there was no beneficial effect observed for any of the interventions. Researchers pointed out that once you exceed certain levels of dietary calcium intake, it doesn’t matter how much you take.
Nutraceutical: Ginkgo (EGb 761)
Indication: Alzheimer’s disease
Source: 21st International Conference of Alzheimer’s Disease International, Istanbul, Turkey
Research: Three hundred and ninety-five outpatients with mild to moderate dementia and neuropsychiatric symptoms (such as depressed mood, anxiety, irritability and indifference) participated in this study. According to researchers, patients with these symptoms represent the overwhelming majority of Alzheimer’s cases in clinical practice. Patients received either 240 mg of EGb 761 or placebo daily. The primary outcome measure in the cognitive domain was the SKT test battery, which is an internationally validated rating scale for dementia. In the neuropsychiatric domain the Neuropsychiatric Inventory (NPI) and the Hamilton Rating Scale for Depression (HAMD) were applied.
Results: After 22 weeks, patients given EGb 761 showed clear improvement and a highly significant difference of 4.5 points compared to those receiving placebo. Similar statistically significant improvements were found for the EGb 761 group on all secondary outcome measures. EGb 761 was also well tolerated.
Source: 21st International Conference of Alzheimer’s Disease International, Istanbul, Turkey
Research: Three hundred and ninety-five outpatients with mild to moderate dementia and neuropsychiatric symptoms (such as depressed mood, anxiety, irritability and indifference) participated in this study. According to researchers, patients with these symptoms represent the overwhelming majority of Alzheimer’s cases in clinical practice. Patients received either 240 mg of EGb 761 or placebo daily. The primary outcome measure in the cognitive domain was the SKT test battery, which is an internationally validated rating scale for dementia. In the neuropsychiatric domain the Neuropsychiatric Inventory (NPI) and the Hamilton Rating Scale for Depression (HAMD) were applied.
Results: After 22 weeks, patients given EGb 761 showed clear improvement and a highly significant difference of 4.5 points compared to those receiving placebo. Similar statistically significant improvements were found for the EGb 761 group on all secondary outcome measures. EGb 761 was also well tolerated.
Nutraceutical: Feverfew (MIG-99)
Indication: Migraine
Source: Cephalalgia, November 2005; 25(11):1031-41.
Research: Researchers carried out a study in 170 migraine patients. At the start of the study, subjects were experiencing five attacks on average over a four-week period. The subjects were randomly assigned to receive MIG-99 three times a day or placebo for up to four months. The primary endpoint was the average number of migraine attacks per 28 days during the treatment months two and three compared with baseline.
Results: In the feverfew group, migraine frequency declined by two attacks per month. In the placebo patients, the corresponding decrease was only one per month. Researchers concluded that the feverfew preparation was 3.4 times more effective than placebo. They also deemed the benefit-risk ratio to be favorable.
Source: Cephalalgia, November 2005; 25(11):1031-41.
Research: Researchers carried out a study in 170 migraine patients. At the start of the study, subjects were experiencing five attacks on average over a four-week period. The subjects were randomly assigned to receive MIG-99 three times a day or placebo for up to four months. The primary endpoint was the average number of migraine attacks per 28 days during the treatment months two and three compared with baseline.
Results: In the feverfew group, migraine frequency declined by two attacks per month. In the placebo patients, the corresponding decrease was only one per month. Researchers concluded that the feverfew preparation was 3.4 times more effective than placebo. They also deemed the benefit-risk ratio to be favorable.
Nutraceutical(s): Omega 3 fatty acids (eicosapentaenoic acid—EPA) and statins
Indication: Heart attack
Source: American Heart Association Meeting, Dallas, TX
Research: Researchers examined data compiled from 18,645 patients in a long-term studying testing the effect of eicosapentaenoic acid (EPA) plus statins versus statins alone in patients with high cholesterol. In addition to taking statins, the fish oil group received 1800 milligrams of high purified SPA in capsule form per day.
Results: Researchers found a 19% reduction in a variety of adverse heart events in the EPA-plus-statins group. The statin-only group had a 3.5% incidence of adverse events over the course of more than four-and-a-half years of follow-up study, while the EPA-plus-statins group had only a 2.8% incidence of negative heart outcomes. The adverse events included in the primary goal of the study were sudden cardiac death, heart attacks, unstable angina or chest pain, and the need to undergo procedures to reopen clogged arteries. The patients were further divided into those with histories of heart disease and those with no such history. When broken out, there was only a significant benefit from EPA demonstrated in the heart disease patients, according to researchers.
Source: American Heart Association Meeting, Dallas, TX
Research: Researchers examined data compiled from 18,645 patients in a long-term studying testing the effect of eicosapentaenoic acid (EPA) plus statins versus statins alone in patients with high cholesterol. In addition to taking statins, the fish oil group received 1800 milligrams of high purified SPA in capsule form per day.
Results: Researchers found a 19% reduction in a variety of adverse heart events in the EPA-plus-statins group. The statin-only group had a 3.5% incidence of adverse events over the course of more than four-and-a-half years of follow-up study, while the EPA-plus-statins group had only a 2.8% incidence of negative heart outcomes. The adverse events included in the primary goal of the study were sudden cardiac death, heart attacks, unstable angina or chest pain, and the need to undergo procedures to reopen clogged arteries. The patients were further divided into those with histories of heart disease and those with no such history. When broken out, there was only a significant benefit from EPA demonstrated in the heart disease patients, according to researchers.
Nutraceutical: Probiotics
Indication: Sick-leave
Source: Environmental Health: A Global Access Science Source, November 2005;4:25.
Research: This study examined the effect of the probiotic Lactobacillus reuteri protectis (ATCC55730) on its ability to improve work-place healthiness by reducing short-term sick-leave caused by respiratory or gastrointestinal infections. Just over 260 employees at TetraPak in Sweden (day workers and three-shift workers) that were healthy at study start were randomized in a double-blind fashion to receive either a daily dose of 108 colony forming units of L. reuteri or placebo for 80 days. The study products were administered with a drinking straw. One hundred and eighty-one subjects complied with the study protocol, 94 were randomized to receive L. reuteri and 87 received placebo.
Results: In the placebo group, 26% reported sick-leave for the defined causes during the study as compared with 11% in the L. reuteri group. The frequency of sick days was nearly 1% in the placebo group and 0.4% in the L. reuteri group. Among the 53 shift-workers, 33% in the placebo group reported sick-leave during the study period as compared with none in the L. reuteri group.
Source: Environmental Health: A Global Access Science Source, November 2005;4:25.
Research: This study examined the effect of the probiotic Lactobacillus reuteri protectis (ATCC55730) on its ability to improve work-place healthiness by reducing short-term sick-leave caused by respiratory or gastrointestinal infections. Just over 260 employees at TetraPak in Sweden (day workers and three-shift workers) that were healthy at study start were randomized in a double-blind fashion to receive either a daily dose of 108 colony forming units of L. reuteri or placebo for 80 days. The study products were administered with a drinking straw. One hundred and eighty-one subjects complied with the study protocol, 94 were randomized to receive L. reuteri and 87 received placebo.
Results: In the placebo group, 26% reported sick-leave for the defined causes during the study as compared with 11% in the L. reuteri group. The frequency of sick days was nearly 1% in the placebo group and 0.4% in the L. reuteri group. Among the 53 shift-workers, 33% in the placebo group reported sick-leave during the study period as compared with none in the L. reuteri group.
Nutraceutical: Vitamins (high-dose)
Indication: Stroke
Source: Stroke, November 2005;36(11): 2404-9.
Research: A previous report from the Vitamin Intervention for Stroke Prevention trial (VISP) intention-to-treat analysis did not show efficacy of combined vitamin therapy for recurrent vascular events in patients with non-disabling stroke. After these results were published, researchers went back and analyzed a subgroup of 2155 subjects more likely to respond to treatment. For this analysis, researchers excluded patients with low and very high B12 levels at baseline (<250 and >637 pmol/L, representing the 25th and 95th percentiles), to exclude those likely to have B12 malabsorption or to be taking B12 supplements outside the study and patients with significant renal impairment.
Results: When the research team compared results of low-dose vitamin versus high-dose vitamin therapy and found that high-dose vitamin supplements reduced recurrent stroke, death and heart disease by 21%. Further, when researchers subdivided patients by baseline levels of vitamin B12, thus identifying those with difficulties absorbing the vitamin, the differences between the low-dose and high-dose groups became greater. As such, researchers indicated that the response to vitamin therapy for lowering homocysteine largely depends on the vitamin B12 status of patients.
Source: Stroke, November 2005;36(11): 2404-9.
Research: A previous report from the Vitamin Intervention for Stroke Prevention trial (VISP) intention-to-treat analysis did not show efficacy of combined vitamin therapy for recurrent vascular events in patients with non-disabling stroke. After these results were published, researchers went back and analyzed a subgroup of 2155 subjects more likely to respond to treatment. For this analysis, researchers excluded patients with low and very high B12 levels at baseline (<250 and >637 pmol/L, representing the 25th and 95th percentiles), to exclude those likely to have B12 malabsorption or to be taking B12 supplements outside the study and patients with significant renal impairment.
Results: When the research team compared results of low-dose vitamin versus high-dose vitamin therapy and found that high-dose vitamin supplements reduced recurrent stroke, death and heart disease by 21%. Further, when researchers subdivided patients by baseline levels of vitamin B12, thus identifying those with difficulties absorbing the vitamin, the differences between the low-dose and high-dose groups became greater. As such, researchers indicated that the response to vitamin therapy for lowering homocysteine largely depends on the vitamin B12 status of patients.
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