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Diet Modification clinical trials

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NCT ID: NCT05113498 Completed - Diet Modification Clinical Trials

The Influence of the Microbiome on the Pharmacokinetics of Flavan-3-ols

PhTI
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Cocoa beans are of major interest due to their various beneficial health effects, indicated to be caused by its cocoa flavan-3-ols. (-)-Epicatechin is the most abundant flavan-3-ol in these cocoa beans. Its metabolization in the colon results in bioactive valerolactone and valeric acid metabolites and derivatives after phase II metabolism. Interindividual differences in health effects following (-)-epicatechin consumption are observed, which are suggested to be caused by large interindividual differences in bioavailable metabolite concentrations. As the colonic microbiota is responsible for the metabolization of ~70% of total (-)-epicatechin intake, and ~42% of total (-)-epicatechin intake leads to valerolactone and valeric acid metabolites, it is hypothesized that the large interindividual variation in microbial gut composition is responsible for the heterogeneity in metabolite concentration and in its subsequent health effects. Furthermore, individuals can be stratified into two pharmacotypes, slow and fast microbial metabolizers, which can produce metabolites at different rates. The aim of this single-arm study is to investigate if the microbial composition in the gut determines the rate and extent of metabolization, following an acute consumption of about 160mg of pure (-)-epicatechin. The pharmacokinetics of the (-)-epicatechin metabolites will be followed in plasma over 48h with a focus on the first fifteen hours and potentially in urine over 24h. Valerolactone and valeric acid metabolite profiles in plasma and urine will be obtained by Q-TOF-LC-MS. The microbial fingerprint of each individual will be obtained via DNA extraction, flow cytometry and 16s rRNA sequencing of fecal samples.

NCT ID: NCT05019859 Completed - Metabolic Syndrome Clinical Trials

Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Investigate if low carb diet could increase serum testosterone level in hypogonadic men

NCT ID: NCT04372771 Completed - Diet Modification Clinical Trials

Comparing Diet and Exercise Approaches in Women

CWW
Start date: April 19, 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.

NCT ID: NCT04038385 Completed - Diet Modification Clinical Trials

WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Whole grains, non-starchy vegetables, fruit, and beans are a consistent feature of diets associated with a lower risk of cancer and other diet-related diseases. For cancer risk reduction, the American Cancer Society recommendation is to consume at least 2.5 cups of a variety of fruits and vegetables daily. Other than dietary choices, weight control and physical activity levels are important modifiable determinants of cancer risk. This study finalized a novel, theory-driven farm-to-WIC intervention developed in preliminary work to promote vegetable intake among low-income adults served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). In New Jersey (the location of the study), WIC provides participants up to $30 in seasonal Farmers' Market Nutrition Program (FMNP) vouchers and monthly cash value vouchers or CVV (valued at $11 for adults and $8 for children at the time of the study) redeemable at farmers' markets. The program combined behaviorally focused nutrition education with the establishment of a WIC-based farmers' market (implemented in the summer of 2019 during the FMNP voucher issuance period). Content to address other modifiable determinants of cancer risk was added. To create additional opportunities for experiential and hands-on learning, monthly trips to an area farmers' market were held (between September 1, 2019 [after the WIC-based market was discontinued] and November 30, 2019 [the end of the local growing season]). The research employed an experimental design to initially test the intervention in 3 WIC agency sites (1 intervention and 2 control sites) with 297 urban, primarily Hispanic adults. Program effects on primary outcomes of vegetable intake (measured objectively using dermal carotenoids as a biomarker of intake and via self-report) and FMNP voucher redemption (objectively assessed using data provided by WIC) were examined at mid- and post-intervention (3 and 6 months post-baseline, respectively). Intervention effects on potential hypothesized mediators and the redemption of CVV at farmers' markets, participant satisfaction with the program, and the cost-effectiveness of the intervention also were examined.

NCT ID: NCT04023604 Completed - Diet Modification Clinical Trials

Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome

S54
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

The primary purpose of this study is to assess whether consuming foods from animals raised with antimicrobial medications influences gut health in adults between the ages of 21-69 years old. Antimicrobial medications are commonly used to help animals avoid infections while growing.

NCT ID: NCT03999632 Completed - Clinical trials for Bariatric Surgery Candidate

Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Candidates to bariatric surgery at The Bariatric and Metabolic Institute at Cleveland Clinic Florida are prescribed a high protein liquid diet for two weeks preoperatively and 2 weeks postoperatively. Whether Wolffia Globosa (Mankai), a plant based wholesome food, can serve as a natural alternative to liquid diet during the 2 week pre-operation and 2 weeks postoperation liquid based diet, is unknown. The investigators aim to address the effect of daily Wolffia Globosa (Mankai) administration on morbid/severely-obese patients during the 2 week pre-operative period and 2 weeks postoperatively as compared to iso protein-iso caloric shake source on the following parameters

NCT ID: NCT03983733 Completed - Healthy Clinical Trials

PREDICT 2: Personalized Responses to Dietary Composition Trial 2

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.

NCT ID: NCT03934476 Completed - Obesity Clinical Trials

The Effects of Lowering Dietary Carbohydrates on Health, Exercise Performance and Wellbeing-related Outcomes

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

The aim of the study is to investigate the long-term effects of the ketogenic diet and exercise (including interactions) on health markers, exercise performance and wellbeing outcomes in sedentary overweight individuals.

NCT ID: NCT03933709 Completed - Diet Modification Clinical Trials

Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy

ENSSIGMCP
Start date: January 12, 2015
Phase: N/A
Study type: Interventional

Background: Most patients with cerebral palsy (CP) are dependent on parents due to the spasticity and limitations in their gross motor function. Additionally, many of them do not respond to physical therapy due to deterioration in their nutritional status, which is secondary to gastrointestinal disorders, parasitosis, dysbiosis and the catabolic state of the disease itself. Evidence suggests that greater independence and better clinical response can be achieved by correcting the nutritional status. However, basic treatments only contemplate the calculation of energy requirements and do not consider important nutrients in particular, supplementation with glutamine, arginine, zinc, selenium, colecalciferol, nicotinic acid, spirulina, omega 3, ascorbic acid, vegetal protein or even probiotics. Objective: To determine the effect of using a nutritional support system (NSS) diet, supplements and probiotic on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III). Material and methods: In an exploratory study with controlled clinical trial design, 30 patients were randomly assigned to receive: 1) dietary surveillance and conventional therapy (FG), 2) deworming and WHO diet (CG), or 3) deworming and the NSS (IG). The patients were recruited from the Children´s Telethon Rehabilitation Center (CRIT) in Tlalnepantla Estado de México. Males and females aged 4-12 years were included with CP and spastic diparesic GMFCS III, who had a full-time caregiver and whose parents agreed to participate. They were studied for thirteen weeks. Gross motor function was evaluated at baseline and at 7 and 13 weeks after therapy using the GMFM scale.

NCT ID: NCT03925636 Completed - Diet Modification Clinical Trials

Specific Carbohydrate Diet for Clostridium Difficile

SCD_cDiff
Start date: June 8, 2016
Phase: N/A
Study type: Interventional

The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Clostridium Difficile Infection. For this study, the investigators will be looking to determine: 1. Is SCD effective for the treatment for Clostridium Difficile Colonization? 2. Is the SCD well tolerated?