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NCT ID: NCT04589221 Completed - Adults Clinical Trials

Sensory and Oral Processing Characteristics of Commonly Consumed Foods

Start date: November 2, 2020
Phase:
Study type: Observational

Rationale: Oral processing behaviours (i.e. eating rate, bite size, chews per bite) play an important role in the onset of satiation and satiety and laboratory studies have shown that people who eat quickly consume more energy during an ad libitum meal. Therefore, one possible approach to control the energy intake is to encourage eating behaviour that slow the rate of calorie intake of the meal. Numerous studies that use external cues and prompts to change the eating rate (e.g. utensil, devices) have shown to produce clinically meaningful results. However, the long-term efficacy of these external manipulation to eating rate remains unclear and have difficulties in adherence. Texture led changes to oral processing behaviours therefore offer an exciting opportunity to adapt an individual's response to structure properties of the food being consumed in a way that maintains the associated eating experience and satiety from food intake. However, no studies to date have investigated how differences food processing influence food texture characteristics and oral processing behaviour and the subsequent impact on energy intake for commonly consumed meals. The proposed study will explore the impact of food texture and oral processing characteristics on energy intake for the minimally-processed and ultra-processed foods or meals, to explore the impact of food processing on texture, oral processing and energy intakes. Objective: The objectives of the study are to characterise the differences in sensory perception, and oral processing behaviours (i.e. eating rate, bite size, chew per bite, oral exposure time etc.) of foods and meals that differ in their degree of processing (Part 1), and to further investigate how texture-based differences in oral processing behaviour influence ad-libitum energy intake (Part 2). This study is also aimed to see how is the texture-based differences in oral processing behaviour modified by degree of food processing (i.e. un-, minimally-processed, processed and ultra-processed foods) (Part 2). Study design: Part 1) Randomised non-blinded feeding trial where participants taste up to 48 food items over 3 test sessions; Part 2) 2x2 randomised crossover design where participants receive 4 treatments (i.e. 4 test meals) over 4 test sessions Study population: Healthy females and males (n=30 for Part 1; n=50 for Part 2) aged 21-50 years with BMI between 18-25 kg/m2 Intervention: Part 1) Participants will taste and evaluate up to 48 food items over 3 sessions in randomised order. Session 1 involves tasting of up to 16 food items and computer task to rate and evaluate their perception and health behaviour. Sessions 2-4 involve evaluation of sensory characteristics, video-recordings of participants eating, and wrist worn accelerometer to track wrist movement while tasting up to 48 food items.

NCT ID: NCT04586907 Completed - Healthy Clinical Trials

A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Start date: November 23, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into the bloodstream and how long the body takes to eliminate it. This study will last up to about 19 weeks including screening period.

NCT ID: NCT04582643 Completed - Metabolic Disease Clinical Trials

Pilot Test of a Healthy Metabolic Behaviour Tool

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

This study aims to validate and pilot test the short-term intervention effect of a newly developed healthy metabolic behaviour tool, named as the 6P tool, on dietary attitude/ practice and body weight changes over one month among overweight and obese women. A total of 50 women, aged 21-40 years, BMI ≥25 kg/m2, who are attending the preconception clinic and planning for a pregnancy over the next one year, will be invited to participate in this pilot study. The recruitment period is estimated to take up to 10 weeks, with subsequent 1 month follow-up visit.

NCT ID: NCT04549103 Completed - Frailty Clinical Trials

Effect of Baduanjin on Functional Performance in Pre-Frail/Frail Older Adults

Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The aim for this study is to investigate the effectiveness of a 16-week realistic community-delivered Baduanjin training program compared to a waitlist control intervention, in improving functional outcomes among pre-frail and frail older adults in Singapore. It is hypothesized that participants that receive 16-week of BDJ training will have significant improvement in physical function (including balance, muscle strength, and endurance); alleviate exhaustion; reduce risk of falling and fear of falling; potentially reverse frailty; reduce depression; and improve quality of life, potentially with greater improvements in area(s) for individuals with lower baseline measures. Whereas, participants in the waitlist control group, will have insignificant changes to their baseline measures.

NCT ID: NCT04545580 Completed - Overactive Bladder Clinical Trials

Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)

OVADER
Start date: September 16, 2020
Phase: Phase 2
Study type: Interventional

The aim of the study is to determine how well the drug BAY1817080 works in OAB patients with urgency urinary incontinence (UUI), defined as involuntary leakage of urine, accompanied or immediately preceded by a sudden compelling desire to void. BAY1817080 is a new drug under development which blocks proteins expressed on the sensory nerves in the bladder. These nerves seem to overreact in OAB patients. This study will test if the treatment with BAY1817080 will reduce the frequency of OAB symptoms. The frequency of OAB symptoms before the treatment and the frequency after 4, 8 and 12 weeks of treatment will be compared. Another important objective of this study will be the assessment of BAY1817080 safety and tolerability in this patient population. BAY1817080 will be compared to a "placebo". A placebo tablet looks like the study drug but does not have any medicine in it. Using a placebo helps to learn if the study drug works. Each participant is expected to take part in the study for about 5 months (around 20-22 weeks).

NCT ID: NCT04525456 Completed - Viral Infection Clinical Trials

Immune Responses With Reduxium

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

Reduxium is a dietary supplement that provides immune support. This natural compound is orally-ingested in the form of droplets in water to boost the immune system and control inflammation. There is not enough data on the mechanism associated with the action of Reduxium or the extent of the immune response increase it produces. In this study, the investigators propose treating a group of healthy volunteers with Reduxium and investigate the utility of this approach in boosting the native and adaptive immune responses that correlate with immune protection. This may form the basis for a future study employing the product in infectious disease patients.

NCT ID: NCT04524390 Completed - Biliary Atresia Clinical Trials

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

EMBARK
Start date: July 8, 2021
Phase: Phase 2
Study type: Interventional

A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).

NCT ID: NCT04522063 Completed - Adults Clinical Trials

Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels

Start date: July 29, 2019
Phase:
Study type: Observational

This research has the following specific objectives: 1. To elucidate how within-person variation in lifestyle factors affect fluctuations in blood glucose concentrations in individuals at high risk of diabetes.This study will elucidate how variation in food intakes, physical activity, and psychological stress affect variation in blood glucose concentrations throughout the day. These results can identify potential targets for interventions to reduce excessive fluctuations in blood glucose concentrations. 2. To describe to what extent the response of individuals to a standardized meal tolerance test can predict real-life variation in blood glucose concentrations. This study will evaluate how much variation in glucose concentrations under real-life conditions can be explained by an individual's response to a standardized mixed meal tolerance test. This will provide insight into the relative importance of variation in dietary and other lifestyle behaviours on an individual's predisposition to higher blood glucose responses. 3. To elucidate the role of oral processing behaviour and saliva properties on blood glucose concentrations. This study will elucidate whether variation in oral processing behaviours (e.g. number of chews taken, oro-sensory exposure time) and saliva properties (a-amylase activity, flow rate) predicts variation in blood glucose concentrations across individuals. 4. To assess whether research collecting multiple repeated measures of food intake, activity, and stress is feasible in large-scale epidemiological studies.This study will provide important insights into the feasibility over the long-run to collect multiple repeated data points on lifestyle behaviours through mobile phone applications and 24-hour glucose and physical activity monitoring in large scale studies in the Singapore population.

NCT ID: NCT04518566 Completed - Clinical trials for Diabetes Mellitus, Type 2

Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device

EMPOWER
Start date: May 11, 2021
Phase: N/A
Study type: Interventional

Chronic diseases are the leading cause of deaths in Singapore. The rising prevalence in chronic diseases with age and Singapore's rapidly aging population calls for new models of care to effectively prevent the onset and delay the progression of these diseases. Advancement in medical technology has offered new innovations that aid healthcare systems in coping with the rapid rising in healthcare needs. These include mobile applications, wearable technologies and machine learning-derived personalized behaviorial interventions. The overall goal of the project is to improve health outcomes in chronic disease patients through delivering targeted nudges via mobile application and wearable to sustain behavioral change. The objective is to design, develop and evaluate an adaptive interventional platform that is capable of delivering personalized behavioral nudges to promote and sustain healthy behavioral changes in senior patients with diabetes. The aim is to assess the clinical effectiveness of real-time personalized educational and behavioral interventions delivered through wearable (FitBit) and an in-integrative mobile application in improving patient activation scores measured using the patient activation measure (PAM). Secondary outcome measures include cost-effectiveness, quality of life, medication adherence, healthcare cost, utilization and lab results. Together with the experts from the SingHealth Regional Health System and National University of Singapore, the investigators will conduct a randomized controlled trial of 1,000 eligible patients. This proposal aims to achieve sustainable and cost-effective behavioral change in diabetes patients through patient-empowerment and targeted chronic disease care.

NCT ID: NCT04517084 Completed - Bariatric Surgery Clinical Trials

Pre-surgical Motivation for Bariatric Surgery

Start date: August 13, 2018
Phase:
Study type: Observational

A study investigating the motivations of patients who had undergone bariatric surgery using data collected from questionnaires given to patients prior to surgery.