Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004543859924 Date of Approval: 14/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of walnut consumption associated with physical activities on biological responses and physical performances in elderly men.
Official scientific title Effects of walnut supplementation associated with concurrent training on biological responses, postural control and isokinetic knee strength in aging men.
Brief summary describing the background and objectives of the trial Biological aging is associated with morphological and biochemical alterations that increase the risk of developing cardiovascular diseases, representing the major cause of morbidity and mortality in older adults. Health benefits of physical training are indisputable in combating age related risks for disease and disability, and understanding the transducers of such benefits is of high interest. Moreover, walnut is nutrient-dense food with a high content of unsaturated fat. While most nuts are high in monounsaturated fatty acids. The aim of this study was to examine the effects of walnut consumption on lipid profile, steroid hormones and systemic inflammation, oxidative stress, postural parameters and isokinetic knee strength in physically active elderly men performing a concurrent training exercise program.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied aging men
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2017
Actual trial start date
Anticipated date of last follow up 26/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
0033 The institutional review board of protection of persons, Sfax, Tunisia
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Walnut consumption and Training Dietary walnut consumption (15g / day) + Trained three sessions per week Six weeks The protocol consisted on two Blood samples and two physical evaluations, 48 hours, pre and post concurrent training (three sessions/ week) for six weeks associated with a walnut supplementation (15g / day) for experimental group. One week prior to and during the experimental period, participants were instructed to refrain from consuming any type of walnut.To evaluate the short-term (6 weeks) effects of intervention, assessments were made prior to the initiation of daily walnut supplementation and at the end of the 6-week training period. The blood samples were conducted 48 hours pre and post intervention. Fasting venous blood samples (10 ml) were drawn after supine rest in the morning at the Laboratory of Biochemistry. Samples were immediately centrifuged at 3000 rpm (× g) and 4°C for 15 min. Aliquots of the resulting plasma were stored at -80°C until analyzed. All samples were analyzed in the same assay run to eliminate inter-assay variance. All assays were performed with Biorad control. For all the above assays, the COBAS 6000 automated system by Roche Diagnostics (Tokyo, Japan) and all relevant diagnostic reagents of the same company were used Bipedal with duel-task (counting from 0 to add 7 each time) balance measurements were performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength was measured with a Cybex® Norm II Medimex. The peak torque of knee extensor and flexor was assessed with five repetitions at speed of 120°.s-1. The training program consisted in cocurrent strenght and endurance training for 3 session per week.The strength exercises were performed first and were immediately followed by the endurance training. Participants of experimental group were asked to consume consume 15 g of walnut (Juglans regia) at 10h:00 am daily additionally to their habitual diets. Documents were provided to assist participants with integrating walnut into their diets. 10
Control Group Training Trained three sessions per week 6 weeks The particiapnts of control group were asked to achieve two Blood samples and two physical evaluations, 48 hours, pre and post concurrent training (three sessions/ week) for six weeks. Before starting the protocol, participants were familiarized with training exercises during 1 week. They were requested to avoid physical activity for 48 hours preceding each test. The blood samples were conducted 48 hours pre and post intervention. Fasting venous blood samples (10 ml) were drawn after supine rest in the morning at the Laboratory of Biochemistry. Samples were immediately centrifuged at 3000 rpm (× g) and 4°C for 15 min. Aliquots of the resulting plasma were stored at -80°C until analyzed. All samples were analyzed in the same assay run to eliminate inter-assay variance. All assays were performed with Biorad control. For all the above assays, the COBAS 6000 automated system by Roche Diagnostics (Tokyo, Japan) and all relevant diagnostic reagents of the same company were used.Bipedal with duel-task (counting from 0 to add 7 each time) balance measurements were performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. Isokinetic knee strength was measured with a Cybex® Norm II Medimex. The peak torque of knee extensor and flexor was assessed with five repetitions at speed of 120°.s-1. The training program consisted in Three session of concrrent stenght and endurance training per week. The strength exercises were performed first and were immediately followed by the endurance training. 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Physically active elderly male (≥65 years). - No smoking or alcoholic - Healthy men - Active men - Participants with a background in systematic physical training during the 2 months before the study were excluded. - Renal, endocrine, gastrointestinal pathology - Walnut allergy, - Pathological ECG. Aged: 65+ Year(s) 65 Year(s) 71 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/05/2017 the institutional review board of protection of persons
Ethics Committee Address
Street address City Postal code Country
Raod Manzel Cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Change in physical performance in both group (Experimental, E and Conctol C). The Isokinetic knee strength was measured with a Cybex® Norm II Medimex. The peak torque of knee extensor and flexor was assessed with five repetitions at speed of 120°.s-1. 2- Change in postural parameters only for E group. Bipedal with duel-task (counting from 0 to add 7 each time) balance measurements were performed in both conditions “open eyes” (OE) and “closed eyes” (CE) using the SATEL® force platform. 3- Change in lipid profile compared to baseline for E but not for C group. Lipid profile (i.e. Total Cholesterol (TC), Total, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglycerides (TG)) were measured enzymatically. 4- Change in systematic inflammation compared from baseline for E but not for C group. CRP was measured with the immune-turbidimetric method. 5- Change in steroid hormones compared from baseline for E but not for C group. Testosterone (T) and Cortisol (C) concentrations were assessed by chemiluminescent micro-particle immunoassay (CMIA). 6- Change is muscular damage compared from baseline for E but not for C group. Creatine Kinase (CK), Lactate Deshydrogenase (LDH) concentrations were respectively measured with N-acetyl-L-cysteine method; the oxidation of lactate on pyruvate method. 48 hours, pre and post intervention
Secondary Outcome 1- Change is sleep quality for Experimental and Control group compared to baseline. The Spiegel sleep questionnaire includes six questions to judge the quality of sleep. It calculates a score that ranges from 0 to 30. The higher is the score, the better is the sleep quality. 2- Change in cognitive performances for Experimental compared to C group. The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for evaluation of cognitive performances. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, Visio-constructional skills, conceptual thinking, calculations and orientation. 3- Change is oxidative parameters compared to baseline for Experiental and not for Control group. MDA, GSH, THT and AOPP were measured by manual protocol. 48 hours, pre and post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The institutional review board of protection of persons raod Manzel cheker Sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Research Unit of the assessment of musculoskeletal disorders Manzel Cheker Sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Research Unit of the assessment of musculoskeletal disorders raod manzel cheker Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Sidi mansour Sfax Tunisia
Mouna Turki Afran Sfax Tunisia
Abdelmoneem Yahia Gramda Sfax Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anis Kamoun aniskamoun02@yahoo.fr +21697358768 Sidi mansour
City Postal code Country Position/Affiliation
Sfax Tunisia 1 The Research Unit of the assessment of musculoskeletal disorders
Role Name Email Phone Street address
Public Enquiries Omar Hammouda hammouda.o@parisnanterre.fr +21652785747 sidi mansour
City Postal code Country Position/Affiliation
Sfax Tunisia 2 The Research Unit of the assessment of musculoskeletal disorders
Role Name Email Phone Street address
Scientific Enquiries Mouna Turki mouna.turki@gmail.com +21622135609 Afran
City Postal code Country Position/Affiliation
Sfax Tunisia 3 The Research Unit of the assessment of musculoskeletal disorders
Role Name Email Phone Street address
Scientific Enquiries Abdelmoneem Yahia abdelmoneem_yahia@yahoo.fr +21698914233 Gramda
City Postal code Country Position/Affiliation
Sfax Tunisia 4 The Research Unit of the assessment of musculoskeletal disorders
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification Informed Consent Form during the trial key for all participant
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet Yes The present study clearly revealed that concurrent training associated with daily 15g of walnuts or not for six weeks significantly increased sleep quality, six minutes walk performance and isokenetic strength parameters. Cognitive performance, postural control Moreover improved for CTW and not for CT. In addition,the levels of High-density lipoprotein (HDL) increased only in CTW compared to baseline (19.8%, p<0.01). Total Cholesterol (TC), Low-density lipoprotein (LDL) and Triglycerides (TG) levels significantly decreased only for CTW (i.e., 13%, 18%, and 18.5% at p<0.01 for all).Testosterone (T) increased after the training compared to pre-training for CTW and CT (10.3%, p< .01, 4.27% p<.05, respectively), but the increase was significantly higher in CTW (p<0.05). Serum Cortisol (C) was lower for CTW compared to CT (p<0.01). C-reactive protein (CRP) decreased in CTW in comparison with CT. 10/04/2020 10/04/2020
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Result URL Hyperlinks Link To Protocol
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