Production of Fortified Biscuit With Chickpea and Crushed Peanut for Improving Cognitive Performance

NCT05281146 | Completed DMC

• 1 other identifier: 20180926
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that globally, school-based fortification and school feeding approaches have been applied to remedy nutritional deficiencies that impact health in the primary school age group. Aim of the study: to produce a fortified biscuit with chickpea and crushed peanut. To evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. The fortified biscuits' effect on auditory attention, visual and working memory, and learning ability was evaluated. Methodology: This study was an interventional study conducted in two stages: stage one was the production of nutritious biscuits that is based on chickpea flour and peanut in addition to whole wheat (extract 72 %), wheat germ, cinnamon, milk, and egg. All these constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children. During stage two, eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or non-dependent group (40 children) to evaluate the impact of the fortified biscuits. All enrolled children and their mothers received 5 cognitive stimulation sessions over four months. The cognitive performance of primary school-aged children was assessed before and after the interventions by a battery of four verbal \& non-verbal intelligence psychological tests. These tests covered short-term and working memory, visual memory, and the ability for categorization, learning for speed of information processing, and auditory attention ability with rising levels of difficulty. These tests were: Digit Span, the figural memory tests, Coding and Auditory vigilance tests A and B respectively. Five items were used to evaluate the physical characteristics of the biscuits: color, odor, taste, consistency, and general acceptance.

Conditions

Cognitive Performance

Keywords

chickpea; crushed peanut; Wheat germ; Cinnamon; short-term memory; working memory; visual memory; information processing; auditory attention ability

Outcome Measures

Primary Outcomes (9)

• Production of Chickpeas and Crushed peanut fortified biscuit

  number of fortified biscuits that are based on chickpeas and crushed peanut produced to cover the sampled children on the base of 3 biscuits per day for 4 months to be given to the children to stimulate their cognitive abilities

  three months after the initiation of the study

• Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group

  An increase in the mean scaled score of the Digit Span Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on short-term and working memory. The unpaired t-test between the two means will be used to detect the differences between biscuits dependent and the non-dependent groups.

  4 months after the initiation of the intervention

• Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group

  An Increase in the mean scaled score of the figural memory test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on visual memory. The unpaired t-test between the two means will be used to detect the differences between biscuits dependent and the non-dependent groups.

  4 months after the initiation of the intervention

• Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group

  An increase of the mean score of right responses and decrease of the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on auditory attention. The unpaired t-test between the two means will be to detect the differences between biscuits dependent and the non-dependent groups

  4 months after the initiation of the intervention

• Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group

  An increase of the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of the intake of the fortified biscuits with the cognitive stimulation. The unpaired t-test between the two means will be to detect the differences between biscuits dependent and the non-dependent groups

  4 months after the initiation of the intervention

• Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to before fortification

  An increase in the mean scaled score of the Digit Span Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on short-term and working memory. The paired t-test was used to detect the differences between (before and after the intervention)

  4 months after the initiation of the intervention

• Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to before fortification

  An Increase in the mean scaled score of the figural memory test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on visual memory. The paired t-test was used to detect the differences between (before and after the intervention)

  4 months after the initiation of the intervention

• Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to before fortification

  An increase in the mean score of right responses and decrease in the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on auditory attention The paired t-test was used to detect the differences between (before and after the intervention)

  4 months after the initiation of the intervention

• Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to before fortification

  An increase in the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of the intake of the fortified biscuits with the cognitive stimulation. The paired t-test was used to detect the differences between (before and after the intervention)

  4 months after the initiation of the intervention

Secondary Outcomes (4)

• Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group

  4 months after the initiation of the intervention

• Mean change of scaled score of the figural memory test as a measure of visual memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group

  4 months after the initiation of the intervention

• Change of mean scaled score of Cognitive stimulation ability to improve auditory attention ability with rising levels of difficulty to detect the cognitive stimulation effect among the fortified biscuits non-dependent group

  4 months after the initiation of the intervention

• Change of mean scaled score of Cognitive stimulation ability to improve learning for speed of information processing to detect the cognitive stimulation effect among the fortified biscuits non-dependent group

  4 months after the initiation of the intervention

Study Arms (2)

chickpea and peanuts biscuits dependent group

ACTIVE COMPARATOR

children aged 8- 12 years attending the village school. This group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months.

Dietary Supplement: Chickpeas and crushed peanuts fortified biscuit; Other: Cognitive stimulation for the mothers; Other: Cognitive stimulation for students

The chickpea and crushed peanut biscuits non-dependent group

ACTIVE COMPARATOR

Matched age and sex children attending the same village school. This group did not receive the fortified biscuits but received their ordinary usual breakfasts or snacks for four months.

Other: Cognitive stimulation for the mothers; Other: Cognitive stimulation for students

Interventions

Chickpeas and crushed peanuts fortified biscuit DIETARY_SUPPLEMENT

This group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months. The chickpeas and crushed peanuts fortified biscuit consisted of wheat flour (extract 72%), Chickpea flour, crushed peanuts, wheat germ, Skimmed milk, corn oil, egg, sugar, Cinnamon, baking powder, salt, and vanilla.

chickpea and peanuts biscuits dependent group

Cognitive stimulation for the mothers OTHER

I. Sessions for mothers * Informing mothers about the most common causes of poor school achievement * Clarification of mother's and family roles in improving student's cognitive abilities * Defining cognitive functions needed for learning and school achievement o Attention, perceptive reasoning, memory, problem solving, proper use of language * Identifying sensory functions necessary for the growth of cognitive functions * Explaining factors that assist in academic excellence

The chickpea and crushed peanut biscuits non-dependent group; chickpea and peanuts biscuits dependent group

Cognitive stimulation for students OTHER

* Activities to improve focus and visual attention * Activities to improve visual memory * Activities to improve vigilance and auditory attention * Explaining types of memory Causes of weak memory Factors helping in improving memory Nutritional elements improving memory * Training on skills of problem-solving

The chickpea and crushed peanut biscuits non-dependent group; chickpea and peanuts biscuits dependent group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• apparently healthy prepubescent boys and girls in the primary schools with four grades.
• Children should not skip breakfast,
• the number of daily meals (at least 3 times per day),
• does not eat any school snack meal during the school day (other than the biscuits under the study for the fortified biscuits dependent group).

You may not qualify if:

• any mental disorder,
• chronic disease,
• visual or auditory impairment, Any malnourished child as detected by both the anthropometric measures and by the Nutritional Status Assessment questionnaire

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Giza, Giza Governorate, 12411, Egypt

Location

Related Publications (35)

• El-Din EMS, Elabd MA, Nassar MS, Metwally AM, Abdellatif GA, Rabah TM, Shalaan A, Shaaban SY, Kandeel W, Etreby LAE, Al-Tohamy M. The Interaction of Social, Physical and Nutritive Factors in Triggering Early Developmental Language Delay in a Sample of Egyptian Children. Open Access Maced J Med Sci. 2019 Sep 12;7(17):2767-2774. doi: 10.3889/oamjms.2019.642. eCollection 2019 Sep 15.

  PMID: 31844434 BACKGROUND

• Kandeel WA, Rabah TM, Zeid DA, El-Din EMS, Metwally AM, Shaalan A, El Etreby LA, Shaaban SY. Determinants of Exclusive Breastfeeding in a Sample of Egyptian Infants. Open Access Maced J Med Sci. 2018 Oct 2;6(10):1818-1823. doi: 10.3889/oamjms.2018.359. eCollection 2018 Oct 25.

  PMID: 30455755 BACKGROUND

• El Din EMS, Rabah TM, Metwally AM, Nassar MS, Elabd MA, Shalaan A, Kandeel W, El Etreby LA, Shaaban SY. Potential Risk Factors of Developmental Cognitive Delay in the First Two Years of Life. Open Access Maced J Med Sci. 2019 Jun 30;7(12):2024-2030. doi: 10.3889/oamjms.2019.566. eCollection 2019 Jun 30.

  PMID: 31406549 BACKGROUND

• Metwally AM, Salah El-Din EM, Shehata MA, Shaalan A, El Etreby LA, Kandeel WA, Shaaban SY, Rabah TM. Early Life Predictors of Socio-Emotional Development in a Sample of Egyptian Infants. PLoS One. 2016 Jul 5;11(7):e0158086. doi: 10.1371/journal.pone.0158086. eCollection 2016.

  PMID: 27379907 BACKGROUND

• Salah El-Din EM, Monir ZM, Shehata MA, Abouelnaga MW, Abushady MM, Youssef MM, Megahed HS, Salem SME, Metwally AM. A comparison of the performance of normal middle social class Egyptian infants and toddlers with the reference norms of the Bayley Scales -third edition (Bayley III): A pilot study. PLoS One. 2021 Dec 2;16(12):e0260138. doi: 10.1371/journal.pone.0260138. eCollection 2021.

  PMID: 34855785 BACKGROUND

• Metwally AM, Shaaban FA, Mahmoud WS, Salah EM, El-Sonbaty MM, Hussien HA, Hamid NA, El Etreby LA, Hassanin A, Monir Z. Vulnerability and Weaknesses of Eating Habits of Overweight School Children as an Entry Risk for COVID-19. Open Access Maced J Med Sci [Internet]. 2020Aug.30 [cited 2020Oct.18];8(T1):158-66. DOI: https://doi.org/10.3889/oamjms.2020.5049 Available from: https://www.id-press.eu/mjms/article/view/5049

  BACKGROUND

• Metwally AM, El-Sonbaty M, El Etreby LA, El-Din EMS, Hamid NA, Hussien HA, Hassanin A, Monir ZM. Stunting and its Determinants among Governmental Primary School Children in Egypt: A School-based Cross-sectional Study. Open Access Maced J Med Sci [Internet]. 2020 Sep.15 ;8(B):650-7. DOI: https://doi.org/10.3889/oamjms.2020.4757

  BACKGROUND

• Metwally AM, El-Sonbaty MM, El Etreby LA, Salah El-Din EM, Abdel Hamid N, Hussien HA, Hassanin AM, Monir ZM. Impact of National Egyptian school feeding program on growth, development, and school achievement of school children. World J Pediatr. 2020 Aug;16(4):393-400. doi: 10.1007/s12519-020-00342-8. Epub 2020 Feb 13.

  PMID: 32056148 BACKGROUND

• Salah EM, Khalifa AG, Metwally AM, Abdel Hamid N, Hussien HA and Moneer ZM: "The Impact Of School Snacks On Cognitive Function Of Primary School Children In Egypt" Journal of Applied Sciences Research, 8(12): 5639-5650, 2012, ISSN 1819-544X

  BACKGROUND

• Bundy D, Burbano C, Grosh M, Gelli A, Jukes M, Drake L. Rethinking school feeding: social safety nets, child development, and the education sector. Washington, D.C. (US): The World Food Programme and the World Bank. 2009.

  BACKGROUND

• WFP (World Food Programme). How school meals contribute to the sustainable development goals. 2017. https://documents.wfp.org/stellent/groups/public/documents/communications/wfp290718.pdf. Accessed 29 Aug 2019.

  BACKGROUND

• Chavan JK, Kadam SS, Salunkhe DK. Biochemistry and technology of chickpea (Cicer arietinum L.) seeds. Crit Rev Food Sci Nutr. 1986;25(2):107-58. doi: 10.1080/10408398709527449.

  PMID: 3549160 BACKGROUND

• Marinangeli CPF, Curran J, Barr SI, Slavin J, Puri S, Swaminathan S, Tapsell L, Patterson CA. Enhancing nutrition with pulses: defining a recommended serving size for adults. Nutr Rev. 2017 Dec 1;75(12):990-1006. doi: 10.1093/nutrit/nux058.

  PMID: 29202192 BACKGROUND

• Arya SS, Salve AR, Chauhan S. Peanuts as functional food: a review. J Food Sci Technol. 2016 Jan;53(1):31-41. doi: 10.1007/s13197-015-2007-9. Epub 2015 Sep 19.

  PMID: 26787930 BACKGROUND

• Moreira-Rosario A, Pinheiro H, Calhau C, Azevedo LF. Can wheat germ have a beneficial effect on human health? A study protocol for a randomised crossover controlled trial to evaluate its health effects. BMJ Open. 2016 Nov 10;6(11):e013098. doi: 10.1136/bmjopen-2016-013098.

  PMID: 28157671 BACKGROUND

• Rao PV, Gan SH. Cinnamon: a multifaceted medicinal plant. Evid Based Complement Alternat Med. 2014;2014:642942. doi: 10.1155/2014/642942. Epub 2014 Apr 10.

  PMID: 24817901 BACKGROUND

• Lee EJ, Chen HY, Hung YC, Chen TY, Lee MY, Yu SC, Chen YH, Chuang IC, Wu TS. Therapeutic window for cinnamophilin following oxygen-glucose deprivation and transient focal cerebral ischemia. Exp Neurol. 2009 May;217(1):74-83. doi: 10.1016/j.expneurol.2009.01.019. Epub 2009 Feb 5.

  PMID: 19416670 BACKGROUND

• Lohman, T.G., A.F. Roche, R. Martorell. Anthropometric standardization reference manual.Champaign, IL: Human kinetics Publishers. 1988.

  BACKGROUND

• Pollitt, E., Methods for the behavioral assessment of the consequences of malnutrition. In Lockwood ER & Scrimshaw NS (eds): Methods of the evaluation of the impact of food and nutrition programs. Tokyo, UNU. 1984

  BACKGROUND

• Newby PK, Hu FB, Rimm EB, Smith-Warner SA, Feskanich D, Sampson L, Willett WC. Reproducibility and validity of the Diet Quality Index Revised as assessed by use of a food-frequency questionnaire. Am J Clin Nutr. 2003 Nov;78(5):941-9. doi: 10.1093/ajcn/78.5.941.

  PMID: 14594780 BACKGROUND

• Wechsler, D.,. Manual for the Wechsler Intelligence Scale for Children - Revised (WISC-R), the Psychological Corporation, NY. 1977.

  BACKGROUND

• Cserjesi R, Molnar D, Luminet O, Lenard L. Is there any relationship between obesity and mental flexibility in children? Appetite. 2007 Nov;49(3):675-8. doi: 10.1016/j.appet.2007.04.001. Epub 2007 Apr 10.

  PMID: 17543417 BACKGROUND

• Ahmed HH, Abla G. Khalifa AG, Eskander EF, Sayed AH and Abdel-Nabi IM. Biochemical and neurological effects of obesity on primary school girls. Nature and Science 2010;8(4)

  BACKGROUND

• Babikian T, Boone KB, Lu P, Arnold G. Sensitivity and specificity of various digit span scores in the detection of suspect effort. Clin Neuropsychol. 2006 Feb;20(1):145-59. doi: 10.1080/13854040590947362.

  PMID: 16393925 BACKGROUND

• de Paula JJ, Malloy-Diniz LF, Romano-Silva MA. Reliability of working memory assessment in neurocognitive disorders: a study of the Digit Span and Corsi Block-Tapping tasks. Braz J Psychiatry. 2016 Jul-Sep;38(3):262-3. doi: 10.1590/1516-4446-2015-1879. No abstract available.

  PMID: 27579598 BACKGROUND

• Conway AR, Kane MJ, Bunting MF, Hambrick DZ, Wilhelm O, Engle RW. Working memory span tasks: A methodological review and user's guide. Psychon Bull Rev. 2005 Oct;12(5):769-86. doi: 10.3758/bf03196772.

  PMID: 16523997 BACKGROUND

• Ismaiel, E and M. Kamel. Wechsler Intelligence Scale for Children Revised, Arabic version. El-Nahda El massryia, Cairo; 1993.

  BACKGROUND

• Sattler, J.M. Assessment of children: Revised and updated (3rd ed.). San Diego: Jerome M. Sattler, Publisher, Inc. 1992

  BACKGROUND

• Yunis, F.A., A.G. Khalifa, Z.M. Monir, A.A. Ayad, S.A. Gabr. Physical growth, nutritional status and intellectual performance among school children of a rural village. Med J Cairo Univ., 1995; 63(4): 971-80.

  BACKGROUND

• Wahba, S.A. and A.G. Khalifa. Breakfast skipping and cognitive functions of primary school children, relation to nutritional status. The Gaz Egypt Paed, 1998; 46(3,4): 203-16

  BACKGROUND

• Khalifa, A.G., F. Hasaballa, S. Tawfik and M. Mansour. Nutritional Status and Cognitive Performance of Primary School Children, Relationship to Social Status and Academic Achievement. JAC, 2001; 12(1): 31-54

  BACKGROUND

• Samer M. Al-Zoubi, Mohammad A. Bani Younes (2015). Low Academic Achievement: Causes and Results. Theory and Practice in Language Studies, Vol. 5, No. 11, pp. 2262-2268

  BACKGROUND

• Puerta, L. (2015). Relationship between cognitive processes and academic performance in high school students. Psychologia: Avances de la Disciplina, 9(2), 85-100

  BACKGROUND

• MeenuDev. (2016) Factors Affecting the Academic Achievement: A Study of Elementary School Students of NCR Delhi, India. Journal of Education and Practice. Vol.7, No.4, pp. 70-74

  BACKGROUND

• Frolek Clark, G. G., Schlabach, T. L., Barnett, M. E., Carr, M. A., Hinkle, B. L., Kluever, J. L., … Kluever, A. L. (2011, August). American Occupational Therapy Association, Inc. Retrieved from www.aota.org

  BACKGROUND

Related Links

• https://documents.wfp.org/stellent/groups/public/documents/communications/wfp290718.pdf.
• WHO, AnthroPlus for personal computers. Manual Software for assessing growth of the world's children and adolescents 2009. Geneva

Study Officials

• Ammal M Metwally, PhD (MD)

  National Research Centre of Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Public Health and Community Medicine

Model Details: Theoretically, fortified biscuits based on chickpea flour and crushed peanuts in addition to wheat germ, and Cinnamon help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving cognitive abilities of school aged children. It is important to practically evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. Eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or the non-dependent group (40 children).

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 16, 2022
• Study Start: November 26, 2018
• Primary Completion: March 5, 2021
• Study Completion: July 5, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the application for patency
• Access Criteria: The data will be accessed through a drive with a link

Locations

EG (1)