Effect of Cashew Apple Juice on the Physiological and Psychological Fitness in the Middle Aged and Elderly Volunteers

NCT02560077 | Completed Phase 1 DMC

• 1 other identifier: HE 531319
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Healthy

Keywords

cognitive; memory; physical fitness; psychological fitness; elderly; middle aged

Outcome Measures

Primary Outcomes (1)

• Cognitive processing (P300) and attention (N100) using Event Related Potential

  4 months

Secondary Outcomes (11)

• Accuracy and speed of working memory using computerized battery test

  4 months

• Mood evaluation using Bond-laddeer questionnaire

  4 months

• Psychological symptom using SCL-90 questionnaire

  4 months

• Malondialdehyde level (MDA) in the serum

  4 months

• Acetylcholinesterase and monoamine oxidase-B activities in serum

  4 months

Study Arms (3)

placebo

PLACEBO COMPARATOR

The placebo and cashew apple fruit juice had the same color and smell

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

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

Other: cashew apple juice

Interventions

placebo OTHER

Subject receive the Placebo product (placebo group had same color and smell of treatment groups)

placebo

cashew apple juice OTHER

Subject received the cashew apple juice at dose of 120 mg/day after meal

cashew apple juice 120 mg/day

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiovascular disease
• Respiratory disease
• Neuropsychological disorders
• Diabetes
• Liver disease
• Renal disease
• Endocrine dysfunction
• Autoimmune disease
• Hematological disorder
• Cancer
• Brain inflammation, head injury

Sponsors & Collaborators

• Khon Kaen University: lead

Study Officials

• Jintanaporn Wattanathorn

  Integrated complementary alternative medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Integrative complementary alternative medicine

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: September 25, 2015
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 23, 2016

Record last verified: 2016-03