Transitional-state food therapeutic nutrition supplement for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Oregon, Eugene, OR
Dementia+2 More
Transitional-state food therapeutic nutrition supplement - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a transitional-state snack supplement can improve nutrition in people with dementia.

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Eligible Conditions

  • Dementia
  • Poor Nutrition

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Transitional-state food therapeutic nutrition supplement will improve 5 primary outcomes and 8 secondary outcomes in patients with Dementia. Measurement will happen over the course of Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0).

Week 8
Change in calcium intake (mg/d)
Change in carbohydrate intake (g/d)
Change in daily energy intake (kcal/d)
Change in fat intake (g/d)
Change in protein intake (g/d)
Change in vitamin D intake (mg/d)
Week 8
Change in malnutrition risk score
Change in malnutrition status (not present, present, moderate, severe)
Week 8
Participant retention rates (%)
Week 0
Participant enrollment rates (%)
Week 1
Change in acceptability of nutrition supplements
Number of test snacks consumed each week
Week 0
Proportion of participants deemed eligible to consume transitional-state foods

Trial Safety

Trial Design

1 Treatment Group

Intervention Arm
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Transitional-state Food Therapeutic Nutrition Supplement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention Arm
DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8) for reporting.

Closest Location

University of Oregon - Eugene, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A person who has been diagnosed with dementia or possible dementia by a medical professional. show original
The patient is medically stable. show original
Community dwelling

Patient Q&A Section

What are the signs of dementia?

"Signs of dementia do not always equate to symptoms. Individuals with symptoms of dementia often have no cognitive impairment. Dementia is defined by the loss of functioning capability. Individuals with dementia are usually bed-ridden or in a caregiving role." - Anonymous Online Contributor

Unverified Answer

What are common treatments for dementia?

"Cognitive behavioral therapy may help to improve cognition in dementia. Exercise and activity, in the form of an exercise program, improves physical function in those with vascular dementia.\n" - Anonymous Online Contributor

Unverified Answer

How many people get dementia a year in the United States?

"In the United States, approximately 8,000 people get DLB each year and about 8,400 people get AD. In 2014, about 5,800 people got DLB and 5,500 got AD in the United States. The annual number of people who get DLB is around three to five times more than the number of people who get AD\n" - Anonymous Online Contributor

Unverified Answer

Can dementia be cured?

"The most important treatments of dementia, including Alzheimer's disease, have proved to be ineffective. For this reason, there is no convincing evidence that any specific treatment exists that would result in an improvement in the natural history of dementia." - Anonymous Online Contributor

Unverified Answer

What is dementia?

"Dementia is a disorder of cognitive functioning that manifests as cognitive deficits in several areas of functioning that are clinically significant. It has a major negative impact on the ability to function at work, carry out daily routines or express identity.\n" - Anonymous Online Contributor

Unverified Answer

What causes dementia?

"The exact cause is unknown, though genetics, diabetes, brain lesions, immune disorders and infection can all affect cognition. As for other illnesses, the brain's ability to handle stress is usually affected first. When that is not sufficient, the body's natural defences will try to fight off the infection. When the disease has become too overwhelming, a number of symptoms can develop, most notably confusion, memory loss, dementia and psychosis.\n" - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating dementia?

"The most significant therapeutic research has not included studies for treating dementia, but rather studies to delay or prevent loss of ability to perform basic functions of daily living (ADLs). As our focus on cognition and neural plasticity grow, we realize we need treatments to help dementia patients maintain their ability to integrate themselves into society. More research is needed to slow or prevent cognitive loss and to preserve or enhance ability to perform ADLs." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of transitional-state food therapeutic nutrition supplement?

"The common side effects of food therapeutic nutrition supplements were nausea, dizziness and vomiting. Some people have the condition of drug-induced vomiting and nausea and the gastrointestinal effect of food therapeutic nutrition supplements. Allergic reactions were rare and were almost always associated with food therapeutic nutrition supplements." - Anonymous Online Contributor

Unverified Answer

Is transitional-state food therapeutic nutrition supplement safe for people?

"The majority of patients admitted to the rehabilitation unit received TFNS.TFNS was given daily to most patients, and was well tolerated. This is a safe adjunct therapy that can promote adherence to the treatment strategy and facilitate the gradual transition to the dietary home and long-term outcomes. TFNS may also be used as a tool in adherence evaluations and research studies." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for dementia?

"Researching for the National Institute of Aging shows that research is crucial for the development of therapeutic options for dementia patients. One of the most important questions for all clinical researchers working on Alzheimer's disease and other age-related dementias is, 'who should be included.' Although the current population is incredibly diverse with respect to age, ethnicity, sex, comorbidities, and dementia severity, there is a large body of research which has shown improvements in functional outcomes of Alzheimer's patients who received treatments that included clinical trials. Even though Alzheimer's disease constitutes only a small percentage of the U.S. population, studies have established that clinical trials could lead to positive and effective effects if they include a sufficient number of individuals." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of dementia?

"A large proportion of dementia cases are idiopathic, i.e. they cannot be explained by any single known risk factor. The other factors which increase the risk of Alzheimer's disease are related to the timing of diagnosis. In addition, the occurrence of stroke is frequently preceded by transient ischemic attack, which can also lead to dementia. In all these cases, age and genetic factors appear to be implicated." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving transitional-state food therapeutic nutrition supplement?

"There is a need for the development and/or deployment of reliable and efficient clinical trials, aimed to validate and substantiate the feasibility of food supplements for improving nutritional status and function of people with severe disability associated with nutritional imbalances." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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