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Showing 1-20 of 49 trials
NCT02016430
Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.
NCT03681054
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=60) have been diagnosed with gestational diabetes mellitus, and are 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 two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). 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 participants gets at least three personal face-to-face counseling sessions, phone calls, 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.
NCT02863822
The purpose of this study is to evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The investigators will compare education in the low FODMAP diet to a standard healthy diet for improving symptoms in FD.
NCT06590805
The purpose of this study was to reveal the effect of electroacupoint on scanty milk production in lactating women.
NCT03235804
This study will investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compositional shifts within the gut microbiota. Moreover, resting energy expenditure, body composition, appetite sensations and soy metabolomics will be explored. This study will be a randomized, parallel group, clinical trial of a 12-week nutritional intervention. A sample size of n=88 participants will be randomly allocated into one of the following groups: * Control group (CON): Participants will be asked to maintain their usual dietary intake over 12 weeks. Their usual dietary intake is expected to reflect the North American dietary pattern (i.e. \~15% of total energy intake coming from protein, \~50% from carbohydrate and \~35% from fat). * Powdered Meal Replacement group (PMR): Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal replacement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The following variables will be analyzed: * Interleukin (IL)-6. * Gut microbiota diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss. * Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and tumor necrosis factor-α); * Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone) * Resting energy expenditure; * Body composition; * Appetite sensations (hunger, satiety, fullness, and prospective food consumption); * Soy polyphenols' metabolomics. * Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research Unit where all assessments will take place. In order to assess participants' adherence and follow-up, dietary intake, body weight and appetite sensations (only for participants assigned to the PMR group) will be assessed weekly during the 12-week intervention period. Additionally, participants will be contacted by phone weekly and reminded to maintain their journal/log.
NCT01129505
Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention program, which includes healthy food choices and increased physical activity initiated during pregnancy and re-instated in the early period after delivery for overweight and obese women. We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention Program (NELIP) to promote healthy family living. An intervention targeting school-aged children on the importance of healthy lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body weights. To break this spiraling cycle of generations of unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related health problems, it is necessary to prevent excessive pregnancy weight gain, high blood sugars in the mother and to promote a healthy lifestyle during pregnancy and early post delivery. With our NELIP team as a cornerstone, and our pilot data already collected with promising results, we foresee an opportunity over the next 3 years to contribute to changing patient care with emphasis on disease prevention and healthy family lifestyle initiation early in life to reverse the trend of childhood obesity. With a solid research-based initiative from the lab to the community by educating health care providers, future health care can be improved by putting prevention-based programs into practice. Healthy women = healthy babies = healthy families = healthy futures!!
NCT02872402
The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM.
NCT03100409
In Mexico, cervical cancer (CC) ranks second in incidence and mortality among women. The National Institute of Cancer in Mexico (lNCan) receives annually about 500 patients with CC, 80% of which are diagnosed with locally advanced disease. The standard treatment for locally advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute benefit of 10%. Adverse effects include gastrointestinal toxicity, which is the most important factor limiting the dosage of pelvic radiation. Cancer treatment, in any modality, induces malnutrition, more so when combined treatments are administered. Radiation induced gastrointestinal toxicity is caused by different factors, among which are malabsorption of bile, fat and carbohydrates, decrease in brush border enzymes, diverticular disease, proctitis, and psychological factors. International guidelines for cancer patients recommend nutritional assessment in these patients before they start treatment, so nutritional risk can be detected and the patient may get started on dietary intervention to prevent malnutrition. Several authors have studied the dietary management that may help reduce the gastrointestinal effects in cancer patients receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended dietary approach is a low residue diet consisting on 20-25% kcal from fat, 5g of lactose and 20g of fiber. Currently the INCan does not follow the nutrition care process for cervical cancer patients; written recommendations are given to the patients with a list of foods allowed or not allowed, with no further nutritional assessment or intervention. From previous studies, the investigators have demonstrated that the current recommendations do not help the patients maintain their nutritional status, during their treatment most patients become malnourished (81%, p\<0.01). Therefore, the aim of this clinical trial is to evaluate a diet low in residue in CC patients, considering the necessary modifications for each patient if morbidities are present, in comparison with the current dietary recommendations used in the INCan.
NCT04991441
Chronic volume overload (VO) is a primary factor responsible for the excessive cardiovascular morbidity and mortality in hemodialysis (HD) patients. VO is caused in part by excessive fluid intake that is secondary to the consumption of a high salt diet. HD patients are often counselled to restrict their dietary sodium intake to help manage thirst and reduce their interdialytic weight gain (IDWG). However, data from recently published investigations demonstrate that dietary counseling alone may be ineffective. The objective of this randomized controlled trial is to determine if short-term feeding of low-sodium meals can "prime" changes in long-term nutrition behavior. It is hypothesized that feeding low-sodium meals for one month will significantly reduce IDWG and related outcomes, and continued dietary counseling and education support for 6 months will result in a sustained reduction in sodium intake upon patient resumption of meal responsibility. HD patients will be recruited and randomized to 2 groups: 1) Low-sodium meal feeding plus dietary counseling; or 2) a weight-list control group that will initially receive dietary counseling alone. IDWG will serve as the primary outcome with fluid volume overload, intradialytic hypotension, cramping, dietary sodium intake, sodium taste sensitivity and preference, and sodium self-efficacy evaluated at 1 and 6 months. This outcomes of this investigation will provide the first data on whether meal provision is an effective tool for dietary modeling and prolonged behavior change in HD patients.
NCT02900898
Rheumatoid arthritis (RA) is a chronic autoimmune disease with metabolic alterations due mainly by the liberation of catabolic cytokines leading to changes in body composition as rheumatoid cachexia. Dynamic exercise (DE) has demonstrated to improve muscular, strength and joint function as well as inflammatory process. Also, a diet focused on the consumption of certain fatty acids like the Mediterranean is recommended to reduce inflammation. The aim of this study is to assess the effect of a dynamic exercise program in combination with a Mediterranean diet in strength, joint mobility and disease activity in women with RA.
NCT03586622
The purpose of this study Is to evaluate if a 4 weeks probiotic VSL#3 treatment and a strict LFD for 4 weeks are equally good in treating IBS symptoms in IBS patients with diarrhoea or mixed predominance and further evaluate the long term effect. Hopefully this one year individualized web-based IBS study will generate a fundament that could be used as a treatment in the primary care/sector to IBS patients.This one year study will be carried out based on an eHealth platform ibs.constant-care.com. Patients will self-measure on the web-program the first 4 weeks before randomization. The patients will fill out different questionnaires regarding symptom severity, adherence, stool consistency and frequency, quality of life, disease course type, food registration and weight. Nearly all of the questionnaires are illustrated to the patients in a traffic light manner (Green, Yellow and Red). They will also self-measure Fecal calprotectin on their smart phones and send in fecal samples for microbiome analysis. In this randomized cross over study - 104 IBS patients will be randomized to either a diet low in FODMAPs (fermentable, oligo-, di- and monosaccharides and polyols, LFD) or the probiotic product VSL#3® for 4 weeks. The probiotic group will receive 2 sachets a day (450 billions live bacteria in one sachet) for 4 weeks. After 4 weeks intervention (LFD or VSL#3) non responders, defined as a reduction of less than 50 points in IBS-SSS will after two weeks wash out period be crossed over. IBS patients randomized to LFD and responds to LFD will after a reintroduction counselling with dieticians at North Zealand university hospital after 4 weeks on a strict LFD start reintroducing high FODMAP foods until symptom flare (individual defined as either Yellow or Red, \>175 in IBS-SSS). Hereafter they will go on a strict LFD again until symptom remission (IBS-SSS below 175, Green zone) - LFD responders will continue with this procedure for 10 months. IBS patients initially randomized to VSL#3 and are after 4 weeks of intervention characterized as responders will not be offered a LFD. Instead they will self- measure on the web with no intervention after the 4 weeks of VSL#3 treatment. When/if they reach a symptom flare ( again individually defined as either Yellow or Red, \>175 point in IBS-SSS) they will be offered another 4 weeks VSL#3 treatment.
NCT03189758
Sodium-adapted magnetic resonance imaging (23Na-MRI) studies have demonstrated that sodium accumulates in certain tissues, including the skin and skeletal muscle, but may be manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis (HD) session. This tissue sodium accumulation is increased with age and in the presence of certain chronic diseases such as renal failure, and may contribute to the development of high blood pressure. It currently not known what the impact of dietary sodium consumption has on tissue sodium in HD patient's and on the subsequent risk of cardiovascular complications either acutely or chronically. The University of Illinois' Biomedical Imaging Center recently completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle sodium levels in the lower leg/calf that will be used for assessing the impact of dietary salt restriction on tissue sodium levels.
NCT03146923
Based on new evidence renal dietitians in Ireland are revising the diet sheet that is used to teach patients about reducing blood phosphate. Changes that renal dietitians plan to make to the dietary phosphorus prescription * Inclusion of some nuts and pulses * More detailed education re phosphate additives * More accurate protein prescription * Inclusion of more whole grains * Encouraging the use of foods with a low phosphorus to protein ratio The investigators want to test the two diet prescription to find out, which one is better at reducing blood phosphate and which one is more acceptable to patients. The investigators also want to make sure it is safe.
NCT03897972
The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12.
NCT03542071
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.
NCT02519946
Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their long-term outcomes and survival. Currently, no effective cardiovascular preventative care is provided for this pediatric population, in part, due to the fact that clinic-based programs are not easily accessible to children and their families. However, tele-health has been show to improve medical outcomes by making care more accessible to these patients. This study aims to meet the urgent need for an effective and sustainable delivery of preventative care to pediatric heart transplant patients using a diet and exercise intervention program delivered live over the internet direct to these patients' homes.
NCT02811276
In the 19th century, researchers found out that the differences in the energy content of macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount of calories individuals burn per day. It was demonstrated that protein has a metabolic advantage when compared to the other macronutrients (carbohydrate and fat). Since these findings, researchers all over the world started to study how diets differing in macronutrient distribution could result in different responses to energy metabolism. Diets with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming more popular, and studies have shown that when people eat high quantities of protein they lose weight and fat mass, maintain the weight loss, and burn more calories per day. The investigators hypothesize that giving high amounts of protein to healthy women will increase the amount of calories and fat they burn per day, increase their satiety, and improve health markers when compared to a normal diet. The increased protein level will be achieved using a nutrition supplement consisted of soy protein, yogurt and honey. To test this, the investigators plan to divide the participants in two groups: one will eat a normal diet and the other a diet with high amounts of protein during one and a half day. After one month they will change groups and eat the other diet for the same period of time. During this period consuming the diets (1.5 days), participants will stay inside a whole body calorimetry suite, which is similar to a hotel bedroom and is able to inform in the most precise way the amount of calories participants will burn and if they are burning more fat. Additionally, before and after each meal participants will have to answer a questionnaire about their appetite sensations and blood will also be collected to analyze health markers.
NCT02426580
This study is a prospective randomized controlled pilot trial/(a combined prospective and retrospective study). The investigators will use wechat intervening dietary protein intake in patients treated with peritoneal dialysis.
NCT02427100
The proposed study will utilize a randomized controlled trial design to pilot-test a 4-week shelter-based diet and physical activity intervention in a sample of homeless adults residing in the transitional shelter at The Bridge Homeless Assistance Center in Dallas, TX (N = 50). Participants will be randomly assigned to a diet/physical activity intervention group (n = 25) or a paid assessment-only control group (n = 25). Three intervention strategies will be employed: 1) computer-tailored newsletters adapted from a program supported for use in other populations, 2) the distribution of fruit and vegetable snacks directly to individuals, and 3) the provision of pedometers and walking goals. Thus, the primary aim of the proposed study is to 1) evaluate the feasibility and effectiveness (relative to an assessment-only control group) of a shelter-based intervention designed to improve dietary intake and increase physical activity among homeless individuals. The main study outcomes will be average daily fruit and vegetable consumption and objective pedometer/ accelerometer assessment of physical activity (assessed weekly) over the 4-week study period, and at a follow-up assessment 4 weeks after the conclusion of the intervention. Secondary aims will focus on: 2) identifying intervention-related differences (relative to the control group) in indicators of physical health including blood pressure, weight, body mass index (BMI), waist circumference, and other dietary variables (i.e., caloric intake, meals consumed outside of the shelter, daily fat and fiber intake) and 3) identifying psychosocial variables associated with dietary quality and physical activity.
NCT03396263
The EatWellQ8 study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, compared with face-to-face nutritional advice, in increasing diet quality. Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has been designed for better usability) and dietary feedback is derived according to adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI).