Biomedical subjects

Andrew Shao

Publications and source records attributed to Andrew Shao.

7 recordsLinked to original sources

PubMed2007

Risk assessment for vitamin D.

The objective of this review was to apply the risk assessment methodology used by the Food and Nutrition Board (FNB) to derive a revised safe Tolerable Upper Intake Level (UL) for vitamin D. New data continue to emerge regarding the health benefits of vitamin D beyond its role in bone. The intakes associated with those benefits suggest a need for levels of supplementation, food fortification, or both that are higher than current levels. A prevailing concern exists, however, regarding the potential for toxicity related to excessive vitamin D intakes. The UL established by the FNB for vitamin D (50 microg, or 2000 IU) is not based on current evidence and is viewed by many as being too restrictive, thus curtailing research, commercial development, and optimization of nutritional policy. Human clinical trial data published subsequent to the establishment of the FNB vitamin D UL published in 1997 support a significantly higher UL. We present a risk assessment based on relevant, well-designed human clinical trials of vitamin D. Collectively, the absence of toxicity in trials conducted in healthy adults that used vitamin D dose > or = 250 microg/d (10,000 IU vitamin D3) supports the confident selection of this value as the UL.

Bone Density Conservation Agents↗

PubMed2006

Risk assessment for glucosamine and chondroitin sulfate.

Glucosamine and chondroitin sulfate are two popular dietary ingredients present in dietary supplements intended to support joint health. A large body of human and animal research suggests that oral intakes of these ingredients, either alone or in combination, reduces joint pain and improves mobility in persons with osteoarthritis. The increased awareness and use of these ingredients in dietary supplements warrant a comprehensive review of their safety. Systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence strongly supports safety at intakes up to 2000 mg/d for glucosamine, and 1200 mg/d for chondroitin sulfate, and these levels are identified as the respective OSL. These values represent the highest levels tested in human clinical trials. The complete absence of adverse effects at these levels supports a confident conclusion of their long-term safety.

Administration, Oral↗

PubMed2006

Risk assessment for carnitine.

Carnitine is a conditionally essential amino acid-like compound involved in the transport of long-chain fatty acids into the mitochondria during the beta-oxidation process. Carnitine has become an increasingly popular ingredient in dietary supplements, especially weight loss and some sports nutrition products. A number of clinical trials have been conducted examining the effect of carnitine supplementation on weight loss and energy balance. Regarding safety, systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 2000mg/day l-carnitine equivalents for chronic supplementation, and this level is identified as the OSL. Although much higher levels have been tested without adverse effects and may be safe, the data for intakes above 2000mg/day are not sufficient for a confident conclusion of long-term safety.

Carnitine↗

PubMed2006

Risk assessment for creatine monohydrate.

Creatine monohydrate (creatine) has become an increasingly popular ingredient in dietary supplements, especially sports nutrition products. A large body of human and animal research suggests that creatine does have a consistent ergogenic effect, particularly with exercises or activities requiring high intensity short bursts of energy. Human data are primarily derived from three types of studies: acute studies, involving high doses (20 g/d) with short duration (< or = 1 week), chronic studies involving lower doses (3-5 g/d) and longer duration (1 year), or a combination of both. Systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe Upper Level of Intake (UL) derived from it unless the newer methods described as the Observed Safe Level (OSL) or Highest Observed Intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 5 g/d for chronic supplementation, and this level is identified as the OSL. Although much higher levels have been tested under acute conditions without adverse effects and may be safe, the data for intakes above 5 g/d are not sufficient for a confident conclusion of long-term safety.

Animals↗

PubMed2006

Risk assessment for coenzyme Q10 (Ubiquinone).

Coenzyme Q10 (CoQ10) widely occurs in organisms and tissues, and is produced and used as both a drug and dietary supplement. Increasing evidence of health benefits of orally administered CoQ10 are leading to daily consumption in larger amounts, and this increase justifies research and risk assessment to evaluate the safety. A large number of clinical trials have been conducted using a range of CoQ10 doses. Reports of nausea and other adverse gastrointestinal effects of CoQ10 cannot be causally related to the active ingredient because there is no dose-response relationship: the adverse effects are no more common at daily intakes of 1200 mg than at a 60 mg. Systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 1200 mg/day, and this level is identified as the OSL. Much higher levels have been tested without adverse effects and may be safe, but the data for intakes above 1200 mg/day are not sufficient for a confident conclusion of safety.

Coenzymes↗

PubMed2006

Risk assessment for the carotenoids lutein and lycopene.

Lutein and lycopene, two prevalent carotenoids in the human diet have become increasingly popular ingredients in dietary supplements. A large body of human and animal research suggests that oral forms of these carotenoids may provide benefits in the areas of eye, prostate, skin and cardiovascular health. The increased awareness and use of these ingredients in dietary supplements warrants a comprehensive review of their safety. Systematic evaluation of the research designs and data provide a basis for risk assessment and the usual tolerable Upper Level of Intake (UL) derived from it if the newer methods described as the Observed Safe Level (OSL) or Highest Observed Intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 20mg/d for lutein, and 75 mg/d for lycopene, and these levels are identified as the respective OSL. Although much higher levels have been tested without adverse effects and may be safe, the data for intakes above these levels are not sufficient for a confident conclusion of long-term safety.

Animals↗

PubMed2004

The science behind lutein.

In humans, as in plants, the xanthophyll lutein is believed to function in two important ways: first as a filter of high energy blue light, and second as an antioxidant that quenches and scavenges photo induced reactive oxygen species (ROS). Evidence suggests that lutein consumption is inversely related to eye diseases such as age-related macular degeneration (AMD) and cataracts. This is supported by the finding that lutein (and a stereo isomer, zeaxanthin) are deposited in the lens and the macula lutea, an area of the retina responsible for central and high acuity vision. Human intervention studies show that lutein supplementation results in increased macular pigment and improved vision in patients with AMD and other ocular diseases. Lutein may also serve to protect skin from UV-induced damage and may help reduce the risk of cardiovascular disease. Crystalline lutein is readily absorbed from foods and from dietary supplements whereas, to enter the bloodstream, lutein esters require prior de-esterification by intestinal enzymes. Unlike the hydrocarbon carotenoids which are mainly found in the LDL fraction, xanthophylls like lutein and zeaxanthin are incorporated into both HDL and LDL. Today, lutein can be obtained from the diet in several different ways, including via supplements, and most recently in functional foods. Animal toxicology studies have been performed to established lutein's safety as a nutrient. These studies have contributed to the classification of purified crystalline lutein as generally recognized as safe (GRAS). The achievement of GRAS status for purified crystalline lutein allows for the addition of this form into several food and beverage applications. This achievement speaks directly to the quality and safety of purified lutein.

Animals↗