HealthyPhase 1NCT02560077
Effect of Cashew Apple Juice on the Physiological and Psychological Fitness in the Middle Aged and Elderly Volunteers
A Phase 1 study testing cashew apple juice in people with Healthy, run by Khon Kaen University.
Trial summary
Cashew or Anacardium occidentale L. is a plant in a family of Anacardiaceae. The fruit of cashew or cashew apple may be consumed fresh, but contains high quantities of tannins yielding a bitter taste and dry mouth feel. Therefore, it is more often prepared as beverage. It is rich in carbohydrate and vitamin C. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cashew apple juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2014
- Phase
- Phase 1
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Live in Khon Kaen, Thailand
- Aged between 55-70 years old
- Body mass index is 18.5 to 24.9
- Signed a written consent form
- In order to ensure the healthy condition , all subjects were subjected to history interviewed by the semi structure form. Moreover they all were assessed physical exam by physician
- All volunteers should not use other nutraceutical compounds or herbs or drugs which influenced on the nervous system function at least 1 month before participating in this study
- On the day of the study, all volunteers felt well and refrain from drinking tea or coffee, or smoking more than 10 pieces/ day
Who cannot join
- Cardiovascular disease
- Respiratory disease
- Neuropsychological disorders
- Diabetes
- Liver disease
- Renal disease
Show all 11Show fewer
- Endocrine dysfunction
- Autoimmune disease
- Hematological disorder
- Cancer
- Brain inflammation, head injury
About this study
Official title: Study the Effect of Cashew Apple Juice on the Physiological and Psychological Fitness in the Middle Aged and Elderly Volunteers
Cashew or Anacardium occidentale L. is a plant in a family of Anacardiaceae. The fruit of cashew or cashew apple may be consumed fresh, but contains high quantities of tannins yielding a bitter taste and dry mouth feel. Therefore, it is more often prepared as beverage. It is rich in carbohydrate and vitamin C. It is also claimed for numerous ailments including antitumor, antimicrobial, urease inhibitory and lipoxygenase activity. In addition, cashew apple juice also has excellent anti-oxidant potential. The preclinical data also demonstrated that cognitive deficit rats induced by cholinotoxin which received A.occidentale or cashew fruit juice for 2 weeks showed the neuroprotective and cognitive enhancing effects.Therefore, the potential benefit of Cashew apple juice on physical fitness and psychological fitness of the middle aged and elderly is focused.
Read the detailed description
Currently, the age-related health problems are increasing their importance markedly due to the increased elderly population. These problems produce the great socio-economic burdens of country. In addition, the quality of both the elderly and their families are also decreased. Therefore, the anti-aging strategy for the elderly has gained much attention. Based on the role of oxidative stresses and free radicals on the age-related pathology, the development of anti-aging health products from substances possessing antioxidant effect has been focused.
Cashew or Anacardium occidentale Linn, one of the economic plants in Thailand, is originated from Latin America and possesses antioxidant effect. In Latin America, this plant is used as anti-aging and memory enhancer. Data obtained from animal study also showed that cashew apple juice could enhance memory and increased muscle performance and induced fatigue resistance. Therefore, cashew apple has the potential to be developed as the physical and psychological fitness enhancer heath product for the elderly. However, no scientific data are available until now. Therefore, this study aimed to develop the cashew apple juice based functional drink and to determine the effect of 12- week consumption of cashew apple juice on physical and psychological fitness of the middle aged and elderly volunteers. The consumption safety of the developed drink was also investigated.
The developed cashew apple juice based functional drink showed antioxidant and acetylcholinesterase suppression activities. Therefore, it was used for the investigation the effect of 12- week consumption of cashew apple juice on physical and psychological fitness of the middle aged and elderly volunteers. In this study, the healthy middle aged and elderly volunteers who were recruited to participate in this study were divided in to various groups consisting of placebo and the Cashew drink treated groups at doses of 120 and 240 mg/day. All subjects had to consume the assigned drinks for 12 weeks. They were determined the parameters related to physical and psychological fitness before treatment and every 4 weeks throughout the study period. The assessments were also performed at 4 week after the cessation of cashew apple juice based drink consumption. The physical fitness assessment was performed via the battery test consisting of various tests including 30-second chair stand test which measured the muscle strength of the lower extremities, hand grip strength test which measured the muscle strength of hand, 6-minute walk test which measured cardio-pulmonary endurance and Tandem test which measured postural balance. The alteration of oxidative stress markers including the malondialdehyde level and the activities of superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GSH-Px) in blood was also motored. The results showed that the volunteers who consumed cashew apple juice based drink at dose of 240 mg/day improved the performance in 30-second chair stand test and 6-minute walk test at 12 weeks of consumption period. The enhanced GSH-Px activity and the decreased MDA level were also observed. Therefore, the data obtained from this study demonstrated the increased muscle strength of the lower extremities and the cardio-pulmonary endurance of the middle-aged and elderly volunteers. The possible underlying mechanism might occur partly via the improved oxidative stress status.
In order to evaluate the psychological fitness, the working memory was assessed using computerized battery test while the attention and cognitive processing were assessed via event related potential. Emotion was assessed via Bond-Läder test whereas psychological symptoms were evaluated by symptoms checklist-90 (SCL-90). In addition, the functions of cholinergic and monoaminergic system especially dopamine were also evaluated using the activities of acetylcholinesterase (AChE), monoamine oxidase (MAO B) as indices respectively. The assessments were performed at the same time schedules as the physical assessment. The results showed that the subjects who consumed cashew apple juice based drink at dose of 240 mg/day showed the following changes; 1) working memory was improves in all domains including the increased power of attention, the increase continuity of attention, the speed of memory and the quality of memory 2) the decreased latency but increased amplitude of N100 and P300 3) the suppression of AChE and MAO-B. Therefore, the current data revealed that the volunteers who consumed the cashew apple juice based drink at dose of 240 mg/day enhance attention and cognitive processing ability giving rise to the improved working memory. The possible underlying mechanism might occur partly via the improved cholinergic and dopaminergic functions.
When the quality of life was determined by using Quest quality questionnaire which modified from SF-36 at the end of study, the results showed that volunteers who consumed cashew apple juice based drink showed the higher quality of life than the volunteer who consumed placebo. These suggested that the cashew apple juice based drink improved both physical and psychological fitness and quality of life of the middle-aged and elderly volunteers.
In order to assure the consumption safety of the consumers, the assessments of hematological and chemical changes of the volunteers were also performed. The results showed that no toxicity was observed throughout the study period. The results obtained from this study demonstrated that the cashew apple juice based drink improved physical and psychological fitness together with the quality of life without toxicity. Therefore, the developed cashew apple juice based drink has the potential to be served as the functional drink in order to enhance physical and psychological fitness for the middle-aged and elderly.
- Conditions
- Healthy
- Being tested
- placebo, cashew apple juice
- Keywords
- cognitive, memory, physical fitness, psychological fitness, elderly, middle aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Subject receive the Placebo product (placebo group had same color and smell of treatment groups)
cashew apple juiceOther
Subject received the cashew apple juice at dose of 120 mg/day after meal
cashew apple juiceOther
Subject received the cashew apple juice at dose of 240 mg/day after meal
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The placebo and cashew apple fruit juice had the same color and smell Receives: Other: placebo |
| cashew apple juice 120 mg/day | Active comparator | The subjects who were assigned as the low dose treatment group received cashew apple fruit juice extract at dose of 120 mg/day Receives: Other: cashew apple juice |
| cashew apple juice 240 mg/day | Active comparator | The subjects who were assigned as the high dose treatment group received cashew apple fruit juice extract at dose of 240 mg/day Receives: Other: cashew apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive processing (P300) and attention (N100) using Event Related Potential
Measured: 4 months
Secondary outcomes (11)
Accuracy and speed of working memory using computerized battery test
Measured: 4 months
Mood evaluation using Bond-laddeer questionnaire
Measured: 4 months
Psychological symptom using SCL-90 questionnaire
Measured: 4 months
Malondialdehyde level (MDA) in the serum
Measured: 4 months
Acetylcholinesterase and monoamine oxidase-B activities in serum
Measured: 4 months
Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase activity (GSH-Px) in the serum
Measured: 4 months
Strength of lower extremities muscles using 30 second chair stand test
Measured: 4 months
Upper body muscular strength using Hand grip strength test
Measured: 4 months
Cardio-pulmonary endurance using 6-minute walk test
Measured: 4 months
Static balance using Tandem stance test
Measured: 4 months
The changes of hematological and clinical chemistry parameters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jintanaporn Wattanathorn, Khon Kaen University
- Investigators
- Jintanaporn Wattanathorn, Principal investigator, Integrated complementary alternative medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560077
- Sponsor's protocol ID
- HE 531319
- Status last verified
- Mar 2016
- First submitted
- 11 Apr 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of Cashew Apple Juice on the Physiological and Psychological Fitness in the Middle Aged and Elderly Volunteers
- ClinicalTrials.gov ID
- NCT02560077
- Acronym / sponsor ID
- HE 531319
- Conditions
- Healthy
- Keywords
- cognitive, memory, physical fitness, psychological fitness, elderly, middle aged
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 2015 (estimated)
- 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.
Cashew or Anacardium occidentale L. is a plant in a family of Anacardiaceae. The fruit of cashew or cashew apple may be consumed fresh, but contains high quantities of tannins yielding a bitter taste and dry mouth feel. Therefore, it is more often prepared as beverage. It is rich in carbohydrate and vitamin C. It is also claimed for numerous ailments including antitumor, antimicrobial, urease inhibitory and lipoxygenase activity. In addition, cashew apple juice also has excellent anti-oxidant potential. The preclinical data also demonstrated that cognitive deficit rats induced by cholinotoxin which received A.occidentale or cashew fruit juice for 2 weeks showed the neuroprotective and cognitive enhancing effects.Therefore, the potential benefit of Cashew apple juice on physical fitness and psychological fitness of the middle aged and elderly is focused.
Detailed description
Currently, the age-related health problems are increasing their importance markedly due to the increased elderly population. These problems produce the great socio-economic burdens of country. In addition, the quality of both the elderly and their families are also decreased. Therefore, the anti-aging strategy for the elderly has gained much attention. Based on the role of oxidative stresses and free radicals on the age-related pathology, the development of anti-aging health products from substances possessing antioxidant effect has been focused.
Cashew or Anacardium occidentale Linn, one of the economic plants in Thailand, is originated from Latin America and possesses antioxidant effect. In Latin America, this plant is used as anti-aging and memory enhancer. Data obtained from animal study also showed that cashew apple juice could enhance memory and increased muscle performance and induced fatigue resistance. Therefore, cashew apple has the potential to be developed as the physical and psychological fitness enhancer heath product for the elderly. However, no scientific data are available until now. Therefore, this study aimed to develop the cashew apple juice based functional drink and to determine the effect of 12- week consumption of cashew apple juice on physical and psychological fitness of the middle aged and elderly volunteers. The consumption safety of the developed drink was also investigated.
The developed cashew apple juice based functional drink showed antioxidant and acetylcholinesterase suppression activities. Therefore, it was used for the investigation the effect of 12- week consumption of cashew apple juice on physical and psychological fitness of the middle aged and elderly volunteers. In this study, the healthy middle aged and elderly volunteers who were recruited to participate in this study were divided in to various groups consisting of placebo and the Cashew drink treated groups at doses of 120 and 240 mg/day. All subjects had to consume the assigned drinks for 12 weeks. They were determined the parameters related to physical and psychological fitness before treatment and every 4 weeks throughout the study period. The assessments were also performed at 4 week after the cessation of cashew apple juice based drink consumption. The physical fitness assessment was performed via the battery test consisting of various tests including 30-second chair stand test which measured the muscle strength of the lower extremities, hand grip strength test which measured the muscle strength of hand, 6-minute walk test which measured cardio-pulmonary endurance and Tandem test which measured postural balance. The alteration of oxidative stress markers including the malondialdehyde level and the activities of superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GSH-Px) in blood was also motored. The results showed that the volunteers who consumed cashew apple juice based drink at dose of 240 mg/day improved the performance in 30-second chair stand test and 6-minute walk test at 12 weeks of consumption period. The enhanced GSH-Px activity and the decreased MDA level were also observed. Therefore, the data obtained from this study demonstrated the increased muscle strength of the lower extremities and the cardio-pulmonary endurance of the middle-aged and elderly volunteers. The possible underlying mechanism might occur partly via the improved oxidative stress status.
In order to evaluate the psychological fitness, the working memory was assessed using computerized battery test while the attention and cognitive processing were assessed via event related potential. Emotion was assessed via Bond-Läder test whereas psychological symptoms were evaluated by symptoms checklist-90 (SCL-90). In addition, the functions of cholinergic and monoaminergic system especially dopamine were also evaluated using the activities of acetylcholinesterase (AChE), monoamine oxidase (MAO B) as indices respectively. The assessments were performed at the same time schedules as the physical assessment. The results showed that the subjects who consumed cashew apple juice based drink at dose of 240 mg/day showed the following changes; 1) working memory was improves in all domains including the increased power of attention, the increase continuity of attention, the speed of memory and the quality of memory 2) the decreased latency but increased amplitude of N100 and P300 3) the suppression of AChE and MAO-B. Therefore, the current data revealed that the volunteers who consumed the cashew apple juice based drink at dose of 240 mg/day enhance attention and cognitive processing ability giving rise to the improved working memory. The possible underlying mechanism might occur partly via the improved cholinergic and dopaminergic functions.
When the quality of life was determined by using Quest quality questionnaire which modified from SF-36 at the end of study, the results showed that volunteers who consumed cashew apple juice based drink showed the higher quality of life than the volunteer who consumed placebo. These suggested that the cashew apple juice based drink improved both physical and psychological fitness and quality of life of the middle-aged and elderly volunteers.
In order to assure the consumption safety of the consumers, the assessments of hematological and chemical changes of the volunteers were also performed. The results showed that no toxicity was observed throughout the study period. The results obtained from this study demonstrated that the cashew apple juice based drink improved physical and psychological fitness together with the quality of life without toxicity. Therefore, the developed cashew apple juice based drink has the potential to be served as the functional drink in order to enhance physical and psychological fitness for the middle-aged and elderly.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placeboThe placebo and cashew apple fruit juice had the same color and smell |
| cashew apple juice 120 mg/day | Active comparator | Other: cashew apple juiceThe subjects who were assigned as the low dose treatment group received cashew apple fruit juice extract at dose of 120 mg/day |
| cashew apple juice 240 mg/day | Active comparator | Other: cashew apple juiceThe subjects who were assigned as the high dose treatment group received cashew apple fruit juice extract at dose of 240 mg/day |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Live in Khon Kaen, Thailand
- Aged between 55-70 years old
- Body mass index is 18.5 to 24.9
- Signed a written consent form
- In order to ensure the healthy condition , all subjects were subjected to history interviewed by the semi structure form. Moreover they all were assessed physical exam by physician
Key exclusion criteria (11 listed)
- Cardiovascular disease
- Respiratory disease
- Neuropsychological disorders
- Diabetes
- Liver disease
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 |
|---|---|---|
| placeboSubject receive the Placebo product (placebo group had same color and smell of treatment groups) | Other | placebo |
| cashew apple juiceSubject received the cashew apple juice at dose of 120 mg/day after meal | Other | cashew apple juice 120 mg/day |
| cashew apple juiceSubject received the cashew apple juice at dose of 240 mg/day after meal | Other | cashew apple juice 240 mg/day |
Primary outcome
Cognitive processing (P300) and attention (N100) using Event Related Potential
Time frame: 4 months
11 secondary outcomes
Accuracy and speed of working memory using computerized battery test
Time frame: 4 months
Mood evaluation using Bond-laddeer questionnaire
Time frame: 4 months
Psychological symptom using SCL-90 questionnaire
Time frame: 4 months
Malondialdehyde level (MDA) in the serum
Time frame: 4 months
Acetylcholinesterase and monoamine oxidase-B activities in serum
Time frame: 4 months
Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase activity (GSH-Px) in the serum
Time frame: 4 months
Strength of lower extremities muscles using 30 second chair stand test
Time frame: 4 months
Upper body muscular strength using Hand grip strength test
Time frame: 4 months
Cardio-pulmonary endurance using 6-minute walk test
Time frame: 4 months
Static balance using Tandem stance test
Time frame: 4 months
The changes of hematological and clinical chemistry parameters
Time frame: 4 months
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 23 Mar 2016.
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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.
Jintanaporn Wattanathorn principal investigator
Integrated complementary alternative medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cashew apple juice in people with Healthy, run by Khon Kaen University.
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 7 inclusion and 11 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cognitive processing (P300) and attention (N100) using Event Related Potential (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2016.