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Dietary Modification clinical trials

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NCT ID: NCT03565718 Completed - Clinical trials for Dietary Modification

The Plant-Based and Soul-Full Study (PASS)

PASS
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The goal of this study is to examine if exposure to vegan soul food restaurants can increase African American adults' perceived benefits of consuming plant-based foods more so than standard guidelines. Although the health benefits of vegan diets are well documented, many people are reluctant to commit to a vegan diet long term. Various issues like food preparation, a lack of social support, or other barriers are often mentioned as reasons why people can't be vegan. This study will (1) find out if short term exposure (i.e. 3 weeks) to culturally tailored curriculum focusing on the health benefits of consuming plant-based foods increases African American adults' perceptions of adopting a vegan diet. And (2) if eating out a few times a week at vegan soul food restaurants can further increase African American adults' perceived benefits of a vegan than having to prepare all meals at home.

NCT ID: NCT03565510 Completed - Clinical trials for Dietary Modification

The Impact of a High-protein Diet on Energy Metabolism in Healthy Men

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the impact of a high-protein diet (achieved with the use of a nutritional supplement, Almased®) versus a diet of a typical North American macronutrient distribution on energy metabolism, metabolic blood markers and appetite sensations. This study will be a randomized, controlled, cross-over trial of an acute nutritional intervention. A total of 20 participants will be randomly assigned (1:1) to one of the following groups: - Control group (CON). - High protein diet group (HP). The diets given to participants in both groups will be eucaloric. While receiving the diets in the whole body calorimetry unit for 32 hours, participants' overall changes in energy metabolism, metabolic blood markers, and appetite sensations will be assessed.

NCT ID: NCT03542071 Terminated - Body Composition Clinical Trials

Dietary Management of Gestational Diabetes in Obese Pregnant Women

eMOM
Start date: July 20, 2018
Phase: N/A
Study type: Interventional

eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI >30 kg/m²) and of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participant gets at least five personal counselling sessions, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.

NCT ID: NCT03528031 Completed - Diabetes Clinical Trials

Habitual Diet and Avocado Trial

HAT
Start date: June 19, 2018
Phase: N/A
Study type: Interventional

The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).

NCT ID: NCT03522779 Completed - Clinical trials for Dietary Modification

Antioxidant Responses to Exercise and Cherry Consumption

Start date: November 2016
Phase: N/A
Study type: Interventional

To date, there are no published studies on the effects of tart cherry consumption on postprandial antioxidant and oxidative stress levels following a high-fat meal. Further, no one has looked at the effects of prior exercise on a high-fat meal that includes high phytonutrients like tart cherries. Therefore, the purpose of this study is to examine the effects of tart cherry consumption on antioxidant and oxidative stress levels in human plasma after consumption of a high-fat meal, as well as the postprandial impact of prior exercise in combination with tart cherry consumption on a high-fat meal.

NCT ID: NCT03496090 Completed - Diet Modification Clinical Trials

Randomized Multicentric Trial to Evaluate a Free Diet With a Progressive Diet in the Treatment of Acute Diverticulitis (DIVERDIET)

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

Phase III trial is designed to demonstrate the non-inferiority of a free diet versus a progressive diet in the treatment of acute diverticulitis (AD) without complications. In this study, the effectiveness of the short-term free diet is evaluated, as well as its safety and the quality of life that is perceived in front of the progressive diet.

NCT ID: NCT03495986 Recruiting - Metabolic Syndrome Clinical Trials

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

SCIENCE
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.

NCT ID: NCT03447340 Completed - Hypertension Clinical Trials

Nepal Pioneer Worksite Intervention Study

NPWIS
Start date: November 9, 2016
Phase: N/A
Study type: Interventional

The proposed project will develop, implement, and test methodology for the design of an acceptable, effective intervention for diabetes prevention in a real-world setting. By determining the effectiveness of the intervention, the study will serve to guide the translation of research into routine public health prevention programs and policy. And, the hands-on experience will directly support the development of expertise, tools and training to advance translational science as a discipline. The study aims to test the effectiveness of an environmental and individual level intervention to prevent diabetes at Dhulikhel Hospital-Kathmandu University Hospital (DH-KUH), Nepal. Specific aims are to measure: Effectiveness of a canteen intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; a systolic blood pressure decrease (SBP) ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a behavioral intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; SBP decrease ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a canteen intervention on change in HbA1C and healthy food intake after six months of the canteen only (CO) intervention compared to the change over six months during the control period. Effectiveness of a behavioral intervention on change in Hba1c and healthy food intake after six months of behavioral intervention plus the canteen (CB) intervention compared to the change over six months during CO. We will recruit 366 adult employees of DH-KUH. At baseline (T1), 6 months (T2), 12 months (T3) and 18 months (T4), we will administer a standard questionnaire to record relevant characteristics of the participants (age, sex, education, income, marital status, and family history of CVD, physical activity, smoking, alcohol intake and diet). We will abstract food consumption data from the administrative database in DH-KUH. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL, total cholesterol, triglycerides). We will measure height, weight, waist circumference, hip circumference, and blood pressure. After 6 months of control period, the participants will receive the canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions. After six months of the canteen intervention, half of the participants will be randomized to receive the behavioral intervention. The behavior intervention will be a combination of intensive education sessions, group counselling, goal setting and monitoring based on the Diabetes Prevention Program (DPP). The primary analysis will use χ^2test use to compare (a) Proportion of individual with score ≥ 2 during CO intervention to the proportion of individual with score ≥ 2 during the control period; (b) Proportion of individual with score ≥ 2 during CB intervention to the proportion of individual with score ≥ 2 during CO intervention. We will conduct a logistic regression with the proportion of individual with score ≥ 2 as outcome and CO vs CB as exposure at T4. Secondary analysis will use paired t-test to compare (a) the change in healthy food intake and HbA1c during CO to the change in healthy food intake and HbA1C during the control period (b) the change in healthy food intake and HbA1C% during CB to the change in healthy food intake and HbA1C% during CO period. We will conduct linear regression with HbA1c% as the outcome and CO vs CB as the exposure variable at T4. Further analysis will adjust for confounding in time-varying variables and assess effect modification.

NCT ID: NCT03432104 Completed - Clinical trials for Dietary Modification

Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

Start date: February 23, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. After a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to identify and quantify phenolic metabolites. In parallel, post-prandial potential anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.

NCT ID: NCT03403166 Completed - Blood Pressure Clinical Trials

Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern

Start date: August 1993
Phase: N/A
Study type: Observational

The present record represents a secondary data analysis of the Dietary Approaches to Stop Hypertension (DASH) trial. Study data and specimens were accessed through the National Heart, Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Coordinating Center (BioLINCC). A global, untargeted, metabolomic profile was used to investigate biomarkers of the DASH dietary pattern as well as blood pressure change.