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Dietary Exposure clinical trials

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NCT ID: NCT06329388 Completed - Child Development Clinical Trials

Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns

Start date: January 18, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device.

NCT ID: NCT06323538 Not yet recruiting - Obesity Clinical Trials

Cohort Study on Plant-based Diets (COPLANT Study)

COPLANT
Start date: April 1, 2024
Phase:
Study type: Observational

The Cohort on Plant-based Diets (COPLANT) study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6,000 participants in Germany and Austria. The COPLANT study focuses on vegan (no animal products), vegetarian (no meat and fish, but dairy products and eggs), pescetarian (no meat, but fish) and omnivorous (mixed diet including all possible animal products) diets. The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social, ecological and economic effects of different plant-based diets in comparison to a mixed diet. In addition to a detailed dietary survey using an app adapted to the needs of this study, the baseline examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants. Furthermore, specific aspects of dietary behavior, physical activity and other lifestyle factors are collected via questionnaires. Follow-up studies are planned at intervals of 5, 10 and 20 years after the baseline visit.

NCT ID: NCT06173271 Recruiting - Sarcopenia Clinical Trials

The Effect of a Multi-intervention Program and Protein Food Sources on Preventing and Mitigating Sarcopenia

Start date: December 29, 2022
Phase: N/A
Study type: Interventional

Sarcopenia is characterized by loss of skeletal muscle mass and strength with advancing age. It is linked to an increased risk of falls, disability, length of hospitalization, poor quality of life, and burden of health care. Nutrition and physical activity are the major modifiable factors to prevent and mitigate sarcopenia. However, most studies focused on the explore the effects of physical activity or single nutrient supplementation. Whether a multi-intervention program combining protein-rich food intake, nutrition education, and exercise can more effectively reduce the risk of sarcopenia still needs to be explored at the community level. This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia. The primary outcome is to evaluate the effect of a multi-intervention program and exercise intervention only. The second outcome is to assess the impact of animal and plant source protein on muscle mass and physical performance. Investigators will recruit the study participants over the age of 60 from the free-living community. All participants were randomized into three groups: animal protein, plant protein, and control group. For 8 weeks, all three groups receive resistance training 3 times/week. However, the animal and plant protein groups provide milk 240 mL and soy milk 230 mL (7-8 g protein/serving) after exercise, respectively, and receive personal nutritional counseling and education to adhere to dietary recommendations. Dual-energy X-Ray using to evaluate the body composition and measure the grip strength, five-time chair stand test, and gait speed to assess physical performance pre- and post-intervention. The results of this study can be used to prevent muscle mass loss and frailty for older adults in the community.

NCT ID: NCT06161883 Completed - Dietary Exposure Clinical Trials

Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity

FRITOCARD
Start date: March 15, 2013
Phase: N/A
Study type: Interventional

The study is a prospective, controlled, randomized two-arm longitudinal crossover trial, performed in a single-centre. Hence, the investigators designed a clinical study aimed to investigate the effects of a daily intake of soffritto in overweight or obese class-1 individuals without other cardiovascular risk. After a run-in period of two-week, participants were randomly separated in two different intervention sequences (two-arms) of six-weeks in which volunteers were administered with a soffritto (100 g/day) or a control group (without soffritto). After the first six-week period, participants had a wash-out phase of two-week followed by a second six-week period in which groups exchanged their interventions. During the duration of the study, the volunteers were asked to maintain their usual diet, excluding raw or cooked tomatoes, as well as tomato-based products (sauces, ketchup, juices, etc.) other than those administered during the study in the corresponding periods.

NCT ID: NCT06102135 Recruiting - Dietary Exposure Clinical Trials

Acceptability and Tolerance Study of Peptide Feed With Fibre

Start date: September 5, 2023
Phase: N/A
Study type: Interventional

Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

NCT ID: NCT06102122 Completed - Dietary Exposure Clinical Trials

Acceptability and Tolerance Study of Adult Tube Feed With Food With Food Derived Ingredients.

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product registration.

NCT ID: NCT06046703 Not yet recruiting - Pregnancy Clinical Trials

Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet

Start date: January 1, 2025
Phase:
Study type: Observational

The goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet. The main aim is to compare vitamin B12 intake. Participants will be asked to: - fill out a health questionnaire - fill out a three-day food diary - undergo blood sampling Researchers will compare pregnant women with a strict plant-based diet and pregnant women with an omnivorous diet to see if their nutritional intake is comparable.

NCT ID: NCT06016322 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Dried Chicory Root in IBD

Chic-IBD
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical pilot trial is to test the use of dried chicory root in patients with IBD. The main questions it aims to answer are: what the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber). Researchers will compare the above mentioned outcomes before and after the intervention.

NCT ID: NCT05842460 Completed - Dietary Exposure Clinical Trials

Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers

Start date: May 24, 2023
Phase: N/A
Study type: Interventional

The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are: - Do "ultraprocessed" warnings affect Brazilian consumers' intention to purchase products? - Do "ultraprocessed" warnings affect Brazilian consumers' product perceptions? Participants will see images of four products carrying either nutrient warning labels (which are currently mandatory in Brazil) or nutrient warning labels alongside an experimental warning label informing that the product is ultraprocessed. Participants will then answer survey questions about each product. Researchers will compare responses between both arms to determine if the "ultraprocessed" warning significantly changes the effect of nutrient warnings.

NCT ID: NCT05763992 Recruiting - Breast Cancer Clinical Trials

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial

BREAKFAST-2
Start date: May 15, 2023
Phase: Phase 2
Study type: Interventional

Italian, multicenter, open-label, two-arm, comparative, randomized phase II study investigating if the addition of the experimental metabolic intervention consisting in cycles of Fasting-Like Approach, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer activity of standard preoperative chemo-immunotherapy in patients with localized invasive Triple Negative Breast Cancer.