Malnourished ElderlyNCT06823739
Personalized Diet and Physical Exercise in Malnourished Older Adults
A study testing Exercise in people with Malnourished Elderly and Quality of Life (QOL), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, personalized diet therapy will be planned by expert dietitians for the volunteers, and they will be instructed on simple stretching and strengthening exercises they can perform independently at home. This instruction will also be supported visually. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnourished Elderly, Quality of Life (QOL), BMI
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Malnourished old aged patients (≥65 years old) who were oriented, cooperated, and inde-pendent in daily living activities were included in the study
Who cannot join
- Exclusion criteria were; <65 years of age, cognitive impairment, immobilization, eat-ing/swallowing disorders, receiving enteral or parenteral nutritional support, and having acute medical problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Diet with or Without Physical Exercise Improves Nutritional Status, Muscle Strength, Physical Performance and Quality of Life in Malnourished Older Adult Patients: a Prospec-tive Randomized Controlled Study
In this study, personalized diet therapy will be planned by expert dietitians for the volunteers, and they will be instructed on simple stretching and strengthening exercises they can perform independently at home. This instruction will also be supported visually.
During the study, the body composition of the volunteers (muscle mass and percentage, fat mass and percentage) will be measured using a BIA device, and their height and weight will also be recorded. Hand grip strength will be measured using a device called a dynamometer.
Read more
These measurements will be repeated monthly for a total of 3 months.
To assess the quality of life of the volunteers, a questionnaire-based test will be conducted, and these measurements will also be repeated monthly for 3 months.
Furthermore, the physical performance of the volunteers will be evaluated by having them stand up from a chair, walk 3 meters, return, and sit back down. This duration will be measured in seconds and recorded. These measurements will also be repeated monthly for 3 months.
Volunteers have no obligations in this research.
Since no invasive procedures (e.g., incisions, tissue or blood sampling, or use of medical devices to examine internal parts of the body) or medical drug therapies will be applied, the risks to the volunteers are minimal.
By implementing personalized diets and standard physical exercise programs, it is anticipated that volunteers will receive medical benefits.
Participation in the study is voluntary, and volunteers can refuse to participate or withdraw from the study at any time without facing any penalties or sanctions and without losing any rights.
Observers, auditors, the ethics committee, institutions, and other relevant health authorities may have direct access to the medical records of the volunteers. However, this information will be kept confidential. By signing this informed consent form, the volunteer and their legal representative grant permission for such access.
Records that reveal the identity of the volunteer will be kept confidential in accordance with relevant regulations, will not be disclosed to the public, and the identity of the volunteer will remain confidential even if the research results are published.
If new information is obtained during the research that could affect the willingness of the volunteer to continue participating, the volunteer and their legal representative will be informed promptly.
For information about the research, the volunteer's rights, or any adverse events related to the research, the volunteer can contact the individuals listed below 24/7 using the provided contact details.
The anticipated duration for a volunteer to participate in this research is 3 months.
No biological material will be obtained from volunteers in this research.
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
This exercise program in PDE group was designed to be performed at home without re-quiring any specialized equipment. It aims to improve physical health, balance, and coor-dination while maintaining muscle strength and flexibility. Patients performed brist walking at least three times a week for a duration of 10 to 30 minutes per session. It also included balance practice and coordination exercises for 10 minutes. These include: Standing on tiptoes, balancing on one foot while holding onto a chair for support, walking in a straight line as if on a narrow beam. Finally, the exercise session ended with a 10-minute cool-down, focusing on relaxing muscles and performing gentle stretches to improve flexibility and reduce tension. All of the exercises were both explained and given in a figured chart, to the patients or the relatives
| Study group | Role | What they receive |
|---|---|---|
| personalized diet | No intervention | Participants in this group received an individualized nutritional intervention tailored to their energy and protein needs (25-30 kcal/kg/day and 1.0-1.2 g/kg/day, respectively). The diet plan included a balance of macronutrients (45-55% carbohydrates, 20-35% fats, and 20-30 g fiber daily) and emphasized protein diversity, whole grains, healthy fats, and adequate hydration. Weekly phone calls monitored adherence to the diet. |
| Personalized Diet with Physical Exercise | Active comparator | Participants in this group received the same personalized diet intervention as the PD group, but with the addition of a structured home-based physical exercise program. The program included:
Warm-up (10 min): Stretching, posture exercises, and stationary marching Strength and balance training (20 min): Bodyweight exercises, balance drills, and brisk walking (10-30 min per session) Cool-down (10 min): Gentle stretching and relaxation Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults
The Mini Nutritional Assessment--Short Form (MNA-SF) test was performed . Body mass index (BMI) was calculated by body weight (kg) by square of the body height (m), and is expressed in kg/m2. The appendicular skeletal muscle mass (ASM) was measured through BIA using a Tanita MC 780 MA (Japan). The ASM index (ASMI) was calculated with by dividing the ASM by the square of the body height (kg/m2).
Muscle strength was measured using a standardized handheld dynamometer (Jamar, USA), the best of 3 measurements made the dominant hand.
A TUG test was performed to evaluate physical performance. The patients sat on a standard chair and were then told to get up from the chair, walk to a line 3 meters away, come back, and sit on the chair again.
The EuroQoL-5 Dimensions (EQ-5D) quality-of-life score and visual analog scale (EQ-5D VAS) were used to assess quality of life. The index score ranged from -0.59 to 1. -0.59 indicates a quality of life worse than death and 1 is a perfect life quality
Measured: Baseline, 4th week, 8th week, and 12th week
Secondary outcomes (1)
Correlation between the QoL score and Body Mass Index, Mını Nutritional Assessment Short Form, Hand Grip Strength, Appendiculer Muscle Mass Index, Timed up and Go
Correlation between the QoL score and other variables' changes are calculated after 12 weeks of intervention in the whole study group with Spearman correlations
Measured: 0th and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Malnourished ElderlyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Altınkaynak, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823739
- Sponsor's protocol ID
- 228630-2021
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lu X, Chu H, Wang L, Yang R, Li Y, Sun W, Yan C, Liu Y, Guo Z, Cheng X. Age- and sex-related differences in muscle strength and physical performance in older Chinese. Aging Clin Exp Res. 2020 May;32(5):877-883. doi: 10.1007/s40520-019-01263-x. Epub 2019 Jul 2.
PubMed 31267378Groessl EJ, Kaplan RM, Barrett-Connor E, Ganiats TG. Body mass index and quality of well-being in a community of older adults. Am J Prev Med. 2004 Feb;26(2):126-9. doi: 10.1016/j.amepre.2003.10.007.
PubMed 14751323Nascimento MM, Gouveia ER, Gouveia BR, Marques A, Campos P, Garcia-Mayor J, Przednowek K, Ihle A. The Mediating Role of Physical Activity and Physical Function in the Association between Body Mass Index and Health-Related Quality of Life: A Population-Based Study with Older Adults. Int J Environ Res Public Health. 2022 Oct 22;19(21):13718. doi: 10.3390/ijerph192113718.
PubMed 36360598Ramsey KA, Meskers CGM, Trappenburg MC, Verlaan S, Reijnierse EM, Whittaker AC, Maier AB. Malnutrition is associated with dynamic physical performance. Aging Clin Exp Res. 2020 Jun;32(6):1085-1092. doi: 10.1007/s40520-019-01295-3. Epub 2019 Aug 19.
PubMed 31429000Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
PubMed 11856064Strasser B, Grote V, Bily W, Nics H, Riedl P, Jira I, Fischer MJ. Short-Term Effects of Dietary Protein Supplementation on Physical Recovery in Older Patients at Risk of Malnutrition during Inpatient Rehabilitation: A Pilot, Randomized, Controlled Trial. Healthcare (Basel). 2023 Aug 17;11(16):2317. doi: 10.3390/healthcare11162317.
PubMed 37628515Chew STH, Tan NC, Cheong M, Oliver J, Baggs G, Choe Y, How CH, Chow WL, Tan CYL, Kwan SC, Husain FS, Low YL, Huynh DTT, Tey SL. Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition. Clin Nutr. 2021 Apr;40(4):1879-1892. doi: 10.1016/j.clnu.2020.10.015. Epub 2020 Oct 15.
PubMed 33268143Labott BK, Bucht H, Morat M, Morat T, Donath L. Effects of Exercise Training on Handgrip Strength in Older Adults: A Meta-Analytical Review. Gerontology. 2019;65(6):686-698. doi: 10.1159/000501203. Epub 2019 Sep 9.
PubMed 31499496Abizanda P, Lopez MD, Garcia VP, Estrella Jde D, da Silva Gonzalez A, Vilardell NB, Torres KA. Effects of an Oral Nutritional Supplementation Plus Physical Exercise Intervention on the Physical Function, Nutritional Status, and Quality of Life in Frail Institutionalized Older Adults: The ACTIVNES Study. J Am Med Dir Assoc. 2015 May 1;16(5):439.e9-439.e16. doi: 10.1016/j.jamda.2015.02.005. Epub 2015 Apr 2.
PubMed 25841327Kramer CS, Groenendijk I, Beers S, Wijnen HH, van de Rest O, de Groot LCPGM. The Association between Malnutrition and Physical Performance in Older Adults: A Systematic Review and Meta-Analysis of Observational Studies. Curr Dev Nutr. 2022 Jan 29;6(4):nzac007. doi: 10.1093/cdn/nzac007. eCollection 2022 Apr.
PubMed 35415390Jiang M, Zou Y, Xin Q, Cai Y, Wang Y, Qin X, Ma D. Dose-response relationship between body mass index and risks of all-cause mortality and disability among the elderly: A systematic review and meta-analysis. Clin Nutr. 2019 Aug;38(4):1511-1523. doi: 10.1016/j.clnu.2018.07.021. Epub 2018 Jul 26.
PubMed 30082166Magzal F, Turroni S, Fabbrini M, Barone M, Vitman Schorr A, Ofran A, Tamir S. A personalized diet intervention improves depression symptoms and changes microbiota and metabolite profiles among community-dwelling older adults. Front Nutr. 2023 Sep 14;10:1234549. doi: 10.3389/fnut.2023.1234549. eCollection 2023.
PubMed 37794974Ordovas JM, Berciano S. Personalized nutrition and healthy aging. Nutr Rev. 2020 Dec 1;78(12 Suppl 2):58-65. doi: 10.1093/nutrit/nuaa102.
PubMed 33259626Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
PubMed 27642056Seid AM, Fentahun N. Prevalence of malnutrition among old people in Africa: systematic review and meta-analysis. BMJ Open. 2022 Nov 30;12(11):e065197. doi: 10.1136/bmjopen-2022-065197.
PubMed 36450428
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Diet with or Without Physical Exercise Improves Nutritional Status, Muscle Strength, Physical Performance and Quality of Life in Malnourished Older Adult Patients: a Prospec-tive Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06823739
- Acronym / sponsor ID
- 228630-2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, personalized diet therapy will be planned by expert dietitians for the volunteers, and they will be instructed on simple stretching and strengthening exercises they can perform independently at home. This instruction will also be supported visually.
During the study, the body composition of the volunteers (muscle mass and percentage, fat mass and percentage) will be measured using a BIA device, and their height and weight will also be recorded. Hand grip strength will be measured using a device called a dynamometer.
These measurements will be repeated monthly for a total of 3 months.
To assess the quality of life of the volunteers, a questionnaire-based test will be conducted, and these measurements will also be repeated monthly for 3 months.
Furthermore, the physical performance of the volunteers will be evaluated by having them stand up from a chair, walk 3 meters, return, and sit back down. This duration will be measured in seconds and recorded. These measurements will also be repeated monthly for 3 months.
Volunteers have no obligations in this research.
Since no invasive procedures (e.g., incisions, tissue or blood sampling, or use of medical devices to examine internal parts of the body) or medical drug therapies will be applied, the risks to the volunteers are minimal.
By implementing personalized diets and standard physical exercise programs, it is anticipated that volunteers will receive medical benefits.
Participation in the study is voluntary, and volunteers can refuse to participate or withdraw from the study at any time without facing any penalties or sanctions and without losing any rights.
Observers, auditors, the ethics committee, institutions, and other relevant health authorities may have direct access to the medical records of the volunteers. However, this information will be kept confidential. By signing this informed consent form, the volunteer and their legal representative grant permission for such access.
Records that reveal the identity of the volunteer will be kept confidential in accordance with relevant regulations, will not be disclosed to the public, and the identity of the volunteer will remain confidential even if the research results are published.
If new information is obtained during the research that could affect the willingness of the volunteer to continue participating, the volunteer and their legal representative will be informed promptly.
For information about the research, the volunteer's rights, or any adverse events related to the research, the volunteer can contact the individuals listed below 24/7 using the provided contact details.
The anticipated duration for a volunteer to participate in this research is 3 months.
No biological material will be obtained from volunteers in this research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personalized diet | No intervention | –Participants in this group received an individualized nutritional intervention tailored to their energy and protein needs (25-30 kcal/kg/day and 1.0-1.2 g/kg/day, respectively). The diet plan included a balance of macronutrients (45-55% carbohydrates, 20-35% fats, and 20-30 g fiber daily) and emphasized protein diversity, whole grains, healthy fats, and adequate hydration. Weekly phone calls monitored adherence to the diet. |
| Personalized Diet with Physical Exercise | Active comparator | Other: ExerciseParticipants in this group received the same personalized diet intervention as the PD group, but with the addition of a structured home-based physical exercise program. The program included: Warm-up (10 min): Stretching, posture exercises, and stationary marching Strength and balance training (20 min): Bodyweight exercises, balance drills, and brisk walking (10-30 min per session) Cool-down (10 min): Gentle stretching and relaxation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Malnourished old aged patients (≥65 years old) who were oriented, cooperated, and inde-pendent in daily living activities were included in the study
Key exclusion criteria (1 listed)
- Exclusion criteria were; <65 years of age, cognitive impairment, immobilization, eat-ing/swallowing disorders, receiving enteral or parenteral nutritional support, and having acute medical problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThis exercise program in PDE group was designed to be performed at home without re-quiring any specialized equipment. It aims to improve physical health, balance, and coor-dination while maintaining muscle strength and flexibility. Patients performed brist walking at least three times a week for a duration of 10 to 30 minutes per session. It also included balance practice and coordination exercises for 10 minutes. These include: Standing on tiptoes, balancing on one foot while holding onto a chair for support, walking in a straight line as if on a narrow beam. Finally, the exercise session ended with a 10-minute cool-down, focusing on relaxing muscles and performing gentle stretches to improve flexibility and reduce tension. All of the exercises were both explained and given in a figured chart, to the patients or the relatives | Other | Personalized Diet with Physical Exercise |
Primary outcome
Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults
Time frame: Baseline, 4th week, 8th week, and 12th week
The Mini Nutritional Assessment--Short Form (MNA-SF) test was performed . Body mass index (BMI) was calculated by body weight (kg) by square of the body height (m), and is expressed in kg/m2. The appendicular skeletal muscle mass (ASM) was measured through BIA using a Tanita MC 780 MA (Japan). The ASM index (ASMI) was calculated with by dividing the ASM by the square of the body height (kg/m2). Muscle strength was measured using a standardized handheld dynamometer (Jamar, USA), the best of 3 measurements made the dominant hand. A TUG test was performed to evaluate physical performance. The patients sat on a standard chair and were then told to get up from the chair, walk to a line 3 meters away, come back, and sit on the chair again. The EuroQoL-5 Dimensions (EQ-5D) quality-of-life score and visual analog scale (EQ-5D VAS) were used to assess quality of life. The index score ranged from -0.59 to 1. -0.59 indicates a quality of life worse than death and 1 is a perfect life quality
1 secondary outcome
Correlation between the QoL score and Body Mass Index, Mını Nutritional Assessment Short Form, Hand Grip Strength, Appendiculer Muscle Mass Index, Timed up and Go
Time frame: 0th and 12th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 31267378Lu X, Chu H, Wang L, Yang R, Li Y, Sun W, Yan C, Liu Y, Guo Z, Cheng X. Age- and sex-related differences in muscle strength and physical performance in older Chinese. Aging Clin Exp Res. 2020 May;32(5):877-883. doi: 10.1007/s40520-019-01263-x. Epub 2019 Jul 2.
- Background: PubMed 14751323Groessl EJ, Kaplan RM, Barrett-Connor E, Ganiats TG. Body mass index and quality of well-being in a community of older adults. Am J Prev Med. 2004 Feb;26(2):126-9. doi: 10.1016/j.amepre.2003.10.007.
- Background: PubMed 36360598Nascimento MM, Gouveia ER, Gouveia BR, Marques A, Campos P, Garcia-Mayor J, Przednowek K, Ihle A. The Mediating Role of Physical Activity and Physical Function in the Association between Body Mass Index and Health-Related Quality of Life: A Population-Based Study with Older Adults. Int J Environ Res Public Health. 2022 Oct 22;19(21):13718. doi: 10.3390/ijerph192113718.
- Background: PubMed 31429000Ramsey KA, Meskers CGM, Trappenburg MC, Verlaan S, Reijnierse EM, Whittaker AC, Maier AB. Malnutrition is associated with dynamic physical performance. Aging Clin Exp Res. 2020 Jun;32(6):1085-1092. doi: 10.1007/s40520-019-01295-3. Epub 2019 Aug 19.
- Background: PubMed 11856064Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
- Background: PubMed 37628515Strasser B, Grote V, Bily W, Nics H, Riedl P, Jira I, Fischer MJ. Short-Term Effects of Dietary Protein Supplementation on Physical Recovery in Older Patients at Risk of Malnutrition during Inpatient Rehabilitation: A Pilot, Randomized, Controlled Trial. Healthcare (Basel). 2023 Aug 17;11(16):2317. doi: 10.3390/healthcare11162317.
- Background: PubMed 33268143Chew STH, Tan NC, Cheong M, Oliver J, Baggs G, Choe Y, How CH, Chow WL, Tan CYL, Kwan SC, Husain FS, Low YL, Huynh DTT, Tey SL. Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition. Clin Nutr. 2021 Apr;40(4):1879-1892. doi: 10.1016/j.clnu.2020.10.015. Epub 2020 Oct 15.
- Background: PubMed 31499496Labott BK, Bucht H, Morat M, Morat T, Donath L. Effects of Exercise Training on Handgrip Strength in Older Adults: A Meta-Analytical Review. Gerontology. 2019;65(6):686-698. doi: 10.1159/000501203. Epub 2019 Sep 9.
- Background: PubMed 25841327Abizanda P, Lopez MD, Garcia VP, Estrella Jde D, da Silva Gonzalez A, Vilardell NB, Torres KA. Effects of an Oral Nutritional Supplementation Plus Physical Exercise Intervention on the Physical Function, Nutritional Status, and Quality of Life in Frail Institutionalized Older Adults: The ACTIVNES Study. J Am Med Dir Assoc. 2015 May 1;16(5):439.e9-439.e16. doi: 10.1016/j.jamda.2015.02.005. Epub 2015 Apr 2.
- Background: PubMed 35415390Kramer CS, Groenendijk I, Beers S, Wijnen HH, van de Rest O, de Groot LCPGM. The Association between Malnutrition and Physical Performance in Older Adults: A Systematic Review and Meta-Analysis of Observational Studies. Curr Dev Nutr. 2022 Jan 29;6(4):nzac007. doi: 10.1093/cdn/nzac007. eCollection 2022 Apr.
- Background: PubMed 30082166Jiang M, Zou Y, Xin Q, Cai Y, Wang Y, Qin X, Ma D. Dose-response relationship between body mass index and risks of all-cause mortality and disability among the elderly: A systematic review and meta-analysis. Clin Nutr. 2019 Aug;38(4):1511-1523. doi: 10.1016/j.clnu.2018.07.021. Epub 2018 Jul 26.
- Background: PubMed 37794974Magzal F, Turroni S, Fabbrini M, Barone M, Vitman Schorr A, Ofran A, Tamir S. A personalized diet intervention improves depression symptoms and changes microbiota and metabolite profiles among community-dwelling older adults. Front Nutr. 2023 Sep 14;10:1234549. doi: 10.3389/fnut.2023.1234549. eCollection 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Malnourished Elderly and Quality of Life (QOL), run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults (time frame: Baseline, 4th week, 8th week, and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823739, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.