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Dietary Modification clinical trials

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NCT ID: NCT03689504 Completed - Malnutrition Clinical Trials

Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

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

This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq | Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control. Aims of the study include: 1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity. 2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

NCT ID: NCT03673267 Completed - Dietary Habits Clinical Trials

Nutricity: A Pilot Study to Improve Parental Nutrition Literacy

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to engage parents and their young children (1-5 years of age) using the mobile intervention, Nutricity. Study goals are to increase parental nutrition literacy and improve eating habits of children.

NCT ID: NCT03640104 Completed - Clinical trials for Overweight and Obesity

Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

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

Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.

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: 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: 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.