Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

NCT03669796

Healthy Volunteers

COMPLETED NA

A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management

NCT02975089

Frail Elderly

COMPLETED NA

Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly

NCT06991855

Sarcopenia Sarcopenia in Elderly

RECRUITING NA

Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

NCT07309120

Low Muscle Mass Low Muscle Strength Low Physical Function

COMPLETED NA

The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly

NCT04857463

Malnutrition Elderly

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Undernutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-arm pretest-posttest

In this study, the subjects served as their own controls. Subjects who were eligible based on inclusion criteria first entered into a 2-week pre-intervention period, during which they received nutrition counseling to keep their routine dietary habits. This was followed by an intervention period, during which an oral nutritional supplement was used over a period of 2 weeks.

Group Type EXPERIMENTAL

Pre-intervention

Intervention Type DIETARY_SUPPLEMENT

First 2-weeks : keeping routine dietary habit

Liquid nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pre-intervention

First 2-weeks : keeping routine dietary habit

Intervention Type DIETARY_SUPPLEMENT

Liquid nutritional supplement

Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* voluntarily agree to participate and sign in informed consent form
* aged 65 years or older
* a serum prealbumin level≤30 mg/dL and a BMI\<25 kg/m2

Exclusion Criteria

* inability to perform oral ingestion
* known allergies to milk or eggs
* an inability to communicate, such as those with Alzheimer's disease
* malabsorption syndrome, a history of gastrectomy or enterectomy
* diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
* any other disease requiring treatment, medication or alcohol abuse
* any condition that the investigator believes may put the subjects at under risk

Minimum Eligible Age

65 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No