OPUS School Meal Study
Metabolic Syndrome XThe aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children. The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.
Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i
Metabolic SyndromeThis study will measure the effect of the agent tadalafil on glucose and insulin homeostasis in people with metabolic syndrome in the presence and absence of an ACE inhibitor.
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Metabolic SyndromeTo achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on genomic stability using noble assays. The investigators propose to study the ability of bioactive plant-based food (Nutrition bar made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (> 50 years, men and postmenopausal women) with and without metabolic syndrome.
Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome
ObesityIn recent decades, the prevalence of obesity has increased dramatically in the United States. Obesity has been associated with an increased risk of the metabolic syndrome, which is characterized by a cluster of metabolic derangements, including insulin resistance, high blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high blood pressure, and inflammation. Lifestyle interventions, including dietary modification, physical activity, and weight loss, form the basis of treatment for individuals with the metabolic syndrome. However, the optimal composition of the diet is not known at this time. Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people find it very difficult to maintain significant weight reductions over time. As a result, weight regain is exceedingly common.
Diurnal Variation of Plasminogen Activator Inhibitor-1
Metabolic Syndrome XTo determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome
Metabolic SyndromeType 2 Diabetes1 moreWalnuts include many potentially beneficial micronutrients and phytochemicals, in this study we propose to examine the effects of walnuts independent of macronutrient content. The purpose of this proposal is to study in depth the short-term effects of walnut consumption in men and women with the metabolic syndrome. Study Aim 1: To investigate the effects of walnuts (48gms per day over 3 days) on insulin resistance in subjects with the metabolic syndrome. Study Aim 2: To investigate the effects of 48gms per day of walnuts over 3 days on lipids and inflammatory markers. Study Aim 3: To assess the possible mechanisms of the biological effects of short-term walnut consumption through assessment of adipokines, resting metabolic rate, gene expression in white blood cells and the effect of walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the excretion of gut peptides and free fatty acids.
Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care
ObesityPre-diabetes1 moreThe purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Bone and Body CompositionObesity3 moreThe broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight women over age 60.
Dairy Products and Metabolic Effects (Norwegian Part)
Metabolic Syndrome XHeart DiseaseFoods containing more dairy fat (and thus a higher proportion of short and medium chain fatty acids and possibly some other nutrients or micronutrients with effect on energy intake, satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone to develop abdominal adiposity and metabolic syndrome. The aim of the study is to test the hypothesis that intake of dairy products has a favorable effect on markers of the metabolic syndrome. To explore such a hypothesis the participants have to be in a free living situation during an extended study period.
Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk
Spinal Cord InjuriesOsteoporosis1 moreRationale: After having a spinal cord injury (SCI), people develop changes in their body composition that influences their long-term health. Individuals with paralysis after SCI will have large declines in their bone density ant increases in fat mass which increases their risk of fracture and heart disease. Therapies to prevent SCI-related changes in body composition and their health effects are needed. Drugs known as "statins" used often to reduce high cholesterol, may help to reduce bone loss and inflammation. Hypothesis: Among adults with SCI for a long time, treatment with a drug named Rosuvastatin or a sugar pill, with supplements (coenzyme Q10, calcium and vitamin D), for twelve months can decrease their endocrine metabolic disease risk by increasing bone density and reducing inflammation. Study Design: A clinical trial will be conducted in Toronto, Ontario and Miami, Florida. Subjects will get statin therapy or placebo (sugar pill) by chance. Study subjects and research staff will not know whether they are taking the study drug or a sugar pill until after the study Subjects: Fifty-four adults (age 18-60 years) with a long-term SCI and no movement below their level of injury. Treatment: Subjects will be prescribed Rosuvastatin 10 mg daily or a sugar pill. In addition, all subjects will receive 100 mg of Co-Q10 daily, calcium carbonate 1250 mg and, vitamin D 2,000 IU once a day. Data Collected: Subjects' bone density will be collected at the start and end of the study. Change in bone density between the two groups will be compared to see if one is better. Blood samples will be collected quarterly to make sure subjects are safe and do not develop problems with their liver or muscles and to measure the effects of the study drugs on inflammation throughout the body. Clinical Implications: Statins may be safe and effective therapy for adults living with SCI who are at increased risk of endocrine metabolic disease as they age.