Not Yet RecruitingPhase 1ACTRN12610000398000

Influence of Omega 3 fatty acids on osmosensation and thirst signaling

Influence of Omega 3 fatty acids on osmosensation and thirst signaling in ambulatory patients aged 65-85 to improve thirst sensation, voluntary fluid intake and improve quality of life in elderly subjects.


Sponsor

Victoria University, Melbourne

Enrollment

40 participants

Start Date

Nov 1, 2010

Study Type

Interventional

Conditions

Summary

Aim: To conduct a prospective trial in a cohort of elderly people to discover the prevalence of dehydration and any association with Omega 3 fatty acid deficiency. This will be followed by a pilot clinical trial aiming to test if 3 month nutritional supplementation with Omega 3 fatty acid may improve thirst sensation, voluntary fluid intake and improve quality of life in comparison with elderly on placebo control. Hypothesis We hypothesise that, there is a positive correlation between prevalence of dehydration and omega 3 fatty acid deficiency in the elderly and supplementation with omega 3 fatty acid will reduce the occurrence of dehydration and improve Quality of life Factors that predispose elderly to dehydration 1. Changes to kidney function and insufficient sensation of thirst. 2. Hormonal changes; normal /increased production of vasopressin, increased response to osmotic stimulation and decreased nocturnal secretions. Atrial natriuretic peptide (ANP) increases secretions with increased stimulation, decreased renin activity and aldosterone production. 3. Neurological impairments altering the hypothalamus and pituitary gland, which affect sensation of thirst. 4. Medication (for example, diuretics and laxatives). 5. Chronic illness, communication issues cognitive difficulties and limited mobility. 6. Not drinking enough water to avoid occurrence of incontinence. 7. Fuid loss due to diarrhoea or vomiting and not compensating for loss. Outcome Improved thirst sensation, voluntary fluid intake and improve quality of life in elderly subjects.


Eligibility

Sex: Both males and femalesMin Age: 65 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether omega-3 fatty acids (fish oil) can improve how older adults sense thirst and regulate body water levels. It is for people aged 65 to 85 who are generally healthy and able to walk independently.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Stage1 (Questionnaire survey) : A self–structured questionnaire survey (assessment for eligibility to participate) and mini-mental state examination (MMSE- psychological assessment for cognitive impai

Stage1 (Questionnaire survey) : A self–structured questionnaire survey (assessment for eligibility to participate) and mini-mental state examination (MMSE- psychological assessment for cognitive impairment) will be conducted among all elderly residents from aged care group facilities in Victoria, (aged 65-85y, inclusive), to screen them for stage 2 and 3 studies. Each participant will be provided an information sheet and consent will be obtained (subjected to approval from Victoria University Human Ethics Committee). Stage 2 (Prospective study- 5 days) This phase study is designed to identify the subjects who are prone to dehydration, thirst deficit, low erythrocyte omega 3 fatty acid levels and whether it is possible accept omega 3 fatty acid supplementation. The fluid intake of the participants in stage 2 will be recorded for 5 days inclusive of a week end. A blood and urine sample will be collected for biochemical analysis. Other clinical assessments include blood pressure and heart rate (both standing and lying position), Body mass index calculation, presence of dry tongue, tongue furrows or dry oral membrane (physical examination) and thirst ratings. A sensory screening test will be conducted to evaluate the participant’s level of acceptance of the fish oil or the placebo oil. Stage 3:The recruitment will be based on subjects found to exhibit dehydration and thirst deficit (from prospective study). In this single blinded study, the participants will be randomly allocated based on age, sex, body weight to Intervention (a) Intervention group: 3 months consumption of omega 3 fatty acids (5 ml fish oil once a day(Melrose, Norwegian fish oil; which contains 815 mg of Eicosapentaenoic and 540 mg of Docosahexaenoic) will be given to intervention group or (b) Control Placebo group: 3 months consumption of 5 ml of cold pressed soya bean oil, both floated on fruit juice (lemon) once a day will be given to placebo participants . Both cohorts will be given additional 5 ml of fruit juice to rinse the mouth.


Locations(1)

Australia

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ACTRN12610000398000