Effect of Camel s Milk Intake on Control of Diabetes: A Randomized Controlled Trial

Transcription

1 Med. J. Cairo Univ., Vol. 82, No. 2, December: 53-59, Effect of Camel s Milk Intake on Control of Diabetes: A Randomized Controlled Trial OSSAMA A. MOSTAFA, Ph.D.*,** and HASSAN M. AL-MUSA, C.A.B.F.M.* The Deartment of Family & Community Medicine, King Khalid College of Medicine, KSA* and Public Health Deartment, Beni Suef College of Medicine, Egyt** Abstract Aim of Study: To investigate the imact of camel s milk intake on control of diabetes. Patients and Methods: A total of 250 diabetics were randomized into either a treatment grou (who received of 250mL camel milk twice weekly in addition to their regular treatment for diabetes, n=150) or a control grou (who received their regular treatment only, n=100). Fasting, ostrandial blood glucose and HbA 1c levels were measured at baseline, 3 and 6 months. Results: There were significant imrovements in the blood glucose levels and HbA 1c levels in the treatment grou only. Reeated measures of blood glucose levels and HbA 1c levels revealed no significant changes in the control grou, comared with significant imrovements in the treatment grou (<0.001 for both blood glucose and HbA 1c levels). Side effects attributed to camel s milk intake were minimal and self-limited. The total cost of camel s milk intake/atient/month is less than 11 US$. Conclusions: Camel s milk intake by diabetic atients is accomanied by significant imrovements in blood sugar and glycemic control. Future studies are needed to quantify the exact dosage and frequency of intake in diabetic atients with different tyes and different disease severity. Further studies are also needed to decide the exact mechanism by which these imrovements occurred, the otimal dose of camel s milk intake, its imact uon diabetes-related comlications and its ossible role in reventing diabetes. This study has been fully suorted by the Deanshi of Scientific Research, King Khalid University, Saudi Arabia, (No. 13) of the first University Project for Research. Key Words: Camel s milk Diabetes mellitus Diabetes control. Introduction THE global revalence of diabetes mellitus (DM) is steadily increasing [1]. A major art of this increase has been rojected to occur in third world Corresondence to: Dr. Ossama A. Mostafa dr_ossama1@yahoo.com countries. Develoing countries will also suffer as a consequence of the raid aging rocess that their oulations will undergo, since the revalence of diabetes increases with age [2]. In the late 1970s and early 1980s DM was not considered a commonly encountered medical diagnosis in the Kingdom of Saudi Arabia (KSA) and its revalence was not different from other arts of the world [3]. This seems to have changed dramatically, as the revalence of DM in Saudi Arabia has become one of the highest in the world [4]. Several studies revealed some glycemic control effects of camel s milk intake in tye-1 diabetes in Euroe, Jaan and the United States [5]. In India, several studies have concluded that tye 1 diabetic atients treated with camel milk needed less exogenous insulin to achieve better control [2,5,6]. Radioimmunoassay tests of camel milk have revealed a high concentration of an insulin-like rotein, whereas it is low in cow milk [7]. Moreover, camel milk does not form a coagulum in an acidic environment. This lack of coagulum formation allows the camel milk to ass raidly through the stomach together with the secific insulin-like rotein and remains available for absortion in the intestine [8]. Though camel milk had been shown to decrease the requirement of insulin in tye 1 diabetes atients, yet not a single study has been done to investigate the effect of camel milk on tye 2. Moreover, although KSA is the world s second roducer of camel milk after Somalia [9], studies investigating the ossible role of camel milk in controlling diabetes among Saudis are quite rare. 53

2 54 Effect of Camel s Milk Intake on Control of Diabetes This study is the first research in Saudi Arabia which exlores the ossible effect of drinking camel milk on diabetes control among atients with tye 1 and tye 2 DM. It aimed to investigate the imact of weekly drinking of camel s milk on control of diabetes. Study objectives: 1- To exlore the effect of drinking camel milk on control of diabetes among both tye 1 and tye 2 diabetics. 2- To assess tolerance of diabetic atients toward drinking camel milk as a theraeutic modality for diabetes. 3- To determine the cost-effectiveness of adding camel milk to the routine management rotocol of diabetic atients. Subjects and Methods This research follows a non-blinded Randomized Controlled Trial (RCT) study design. It was conducted in Abha City during Following a simle random samle, 250 diabetic atients were randomized into either a treatment grou (who received asteurized camel milk twice weekly in addition to their regular treatment for DM, n=150) or a control grou, (who received their regular treatment for DM only, n=100). The frequency of twice weekly intake of camel s milk has been decided based on the study of Mohamed et al. [10]. Patients with allergy to milk, any associated chronic disease (e.g., hyertension, renal disease, heart disease, etc.) or diabetic comlications (e.g., retinoathy, diabetic foot, etc.) were not included into this study. Moreover, atients who are used to drink camel milk were not included into the control study. A data collection tool was constructed by the researchers. All study variables were included, i.e., atient s file number, gender, age, tye of diabetes, duration of diabetes, fasting and two-hour ostrandial blood glucose level, and HbA 1c levels at start of study, after 3 months and 6 months. Before start of the study, objectives of the resent study were fully exlained to every otential articiant. It was clearly emhasized that each atient is totally free to accet or to refuse to contribute in the study and the collected data will be used only for research. The researchers met each study articiant once monthly to check their blood fasting and two-hour ostrandial blood glucose. Particiants in the treatment grou were instructed to drink 250cc of asteurized camel milk twice weekly beside their regular treatment for diabetes. Counseling and health education for articiants was rovided. HbA 1c levels were assessed every three months, i.e., at baseline, 3 and 6 months. All articiants were rovided with blood glucose monitoring devices for daily check for their blood glucose levels. Moreover, they were ket into continued communication with the researchers through the hone to get any consultation, reort any comment or comlaint and to arrange for an additional meeting when necessary. The Statistical Package for Social Sciences (SPSS version 17.0) was used for data entry and analysis. Descritive statistics were calculated and the aroriate tests of significance were alied accordingly (i.e., χ 2, correlation, t-test and reeated measures ANOVA). Differences or correlations were considered as statistically significant when <0.05. Results Table (1-A) shows that the mean age of articiants in the control grou was ± years while that of atients in the treatment grou was 38.50± years. The mean duration of diabetes in the control grou was 4.74 ±4.28 years, while that for atients in the treatment grou was 5.11±4.73 years. Baseline HbA1c mean levels were 8.23±0.93% for atients in the control grou and 8.21 ±0.86% in the treatment grou. There were no significant differences between atients characteristics in the control grou and those in the treatment grou regarding their age, duration of diabetes and HbA 1c level. Table (1-B) shows that the control grou comrised 53 males (53%) and 47 females (47%), while the treatment grou comrised 79 males (52.7%) and 71 females (47.3%). Most cases belonged to tye 2 (91% and 88% in the control and treatment grous, resectively). There were no significant differences between atients characteristics in the control grou and those in the treatment grou regarding their gender or tye of diabetes. Table (2-A) shows no significant differences between blood glucose levels of tye 1 diabetic atients in the control grou comared with the treatment at baseline, 3 months and 6 months later. However, aired comarisons between fasting and ostrandial blood glucose levels were not significant among the control grou while highly significant in the treatment grou (<0.001).

3 Ossama A. Mostafa & Hassan M. Al-Musa 55 Table (2-B) shows no significant differences between HbA 1c levels of tye 1 diabetic atients in the control grou comared with the treatment grou at baseline, 3 months and 6 months later. However, reeated measures revealed no significant changes in the control grou (=0.248), comared with a highly significant difference in the treatment grou (<0.01), (Fig. 1). Table (3-A) shows no significant differences between fasting blood glucose levels of tye 2 diabetic atients in the control grou comared with the treatment at baseline, 3 months and 6 months later. However, there were significantly lower ostrandial blood glucose levels among tye 2 diabetic atients in the treatment grou comared with atients in the control grou at baseline, 3 months and 6 months later ( <0.001). Moreover, aired comarisons between fasting and ostrandial blood glucose levels were not significant in the control grou while highly significant in the treatment grou ( <0.001). Table (3-B) shows no significant differences between HbA 1c levels of tye 2 diabetic atients in the control grou comared with the treatment grou at baseline and 3 months later, while atients in the treatment grou had significantly lower HbA 1c mean level than those in the control grou at 6 months (=0.008). Reeated measures revealed no significant changes in the control grou (=0.194), comared with a highly significant difference in the treatment grou (<0.001), (Fig. 2). Table (4-A) shows no significant differences between fasting and ostrandial blood glucose levels of tye 2 male diabetic atients in the treatment grou comared with those of female atients. Table (4-B) shows no significant differences between HbA 1c levels of tye 2 male diabetic atients in the treatment grou comared with those of female atients. However, reeated measures revealed statistically significant differences among male and female atients (<0.001 for both). Table (5-A) shows significantly ositive correlation between age of atients and different fasting and ostrandial blood glucose levels among diabetic atients in the treatment grou. On the other hand, there was an insignificant ositive correlation between duration of diabetes and different fasting and ostrandial blood glucose levels among diabetic atients in the treatment grou. Table (5-B) shows significantly ositive correlation coefficients between both age of atient and duration of diabetes with different HbA1c levels among diabetic atients in the treatment grou. Table (6) shows that the main side effects attributed to camel s milk intake were mild distension (6.7%), unleasant taste (6%) and transient diarrhea (3.3%). Those who comlained of the taste were advised to add a minimal amount of an artificial sweetener. This action was temorary and almost all articiants got used to its taste by time. Moreover, all these reorted side effects were selflimited and did not lead to interrution of camel's milk intake. Table (1-A): Baseline descritive statistics of articiants (+) according to study grous. Control grou Treatment grou Variables (n=100) (n=150) Age Duration of diabetes HbA 1c level Table (1-B): Baseline descritive statistics of articiants (frequency and ercentage) according to study grous. Variables Control grou (n=100) Treatment grou (n=150) No. % No. % Gender: Males Females Tye of diabetes: Tye Tye 2 Table (2-A): Fasting and ostrandial blood sugar levels (mg/dl) of tye 1 diabetic atients in the treatment grou comared with that of the control grou. Control grou (n=9) Treatment grou (n=18) Fasting Postrandial Fasting Postrandial Fasting Postrandial

4 56 Effect of Camel s Milk Intake on Control of Diabetes Table (2-B): HbA 1 c levels (%) of tye 1 diabetic atients in the treatment grou comared with that of the control grou Control grou (n=9) Treatment grou (n=18) 2 Table (4-A): Fasting and ostrandial blood sugar levels (mg/dl) of male atients in the treatment grou comared with that of the female atients in the same grou. Males (n=79) Females (n=71) Baseline Three months Six months < s for reeated measures ANOVA. 2 - for unaired t-test Fasting Postrandial Fasting Postrandial Table (3-A): Fasting and ostrandial blood sugar levels (mg/dl) of tye 2 diabetic atients in the treatment grou comared with that of the control grou. Fasting Postrandial Control grou (n=91) Treatment grou (n=132) Table (4-B): HbA 1c levels (%) of tye 2 diabetic male atients in the study grou comared with that of the female atients in the same grou. Fasting Postrandial <0.001 Fasting Postrandial <0.001 Fasting Postrandial <0.001 Table (3-B): HbA 1c levels (%) of tye 2 diabetic atients in the treatment grou comared with that of the control grou Control grou (n=91) Treatment grou (n=132) Baseline Three months Six months Males (n=79) Females (n=71) Baseline Three months Six months <0.001 < s for reeated measures ANOVA. 2 - for unaired t-test. Table (5-A): Correlation between blood glucose levels of tye 2 diabetic atients in the treatment grou with age of atient and duration of diabetes (n=150). Age of atient Duration of disease r r Fasting < Postrandial < Fasting Postrandial s for reeated measures ANOVA. 2 - for unaired t-test. <0.001 Fasting Postrandial <

5 Ossama A. Mostafa & Hassan M. Al-Musa 57 Table (5-B): Correlation between HbA 1c levels of diabetic atients in the study grou with age of atient and duration of diabetes (n=150). HbAlc (%) Age of atient Duration of disease Baseline <0.001 Three months <0.001 Six months <0.001 Table (6): Main side effects reorted by articiants in the treatment grou. Reorted side effect Mild distension Not very tasty Transient diarrhea r r No. % Baseline 3 months 6 months Discussion Results of this study revealed significantly better control for blood glucose levels among articiants in the treatment grou, who showed highly significant decrease in their blood glucose levels toward normality two hours after intake of camel s milk. This finding was significant both in atients with tye 1 and tye 2 DM (Tables 2-A, 3-A). Moreover, atients in the treatment grou exerienced significantly better glycemic control than those in the control grou. There was a gradual decline in HbA1c levels among atients in the treatment grou toward otimal levels within 6 months of camel s milk intake (Tables 2-B, 3-B). However, these findings did not differ significantly according to atients gender (Tables 4-A, 4-B). These findings are in agreement with those reorted by Mohamed et al., [10] in Egyt, who randomized 54 tye 1 diabetic atients into two study grous (n=27 each), one received the usual management rotocol (diet, exercise, and insulin), whereas the other received 500mL of camel milk twice weekly in addition to the standard management. After 16 weeks, the following arameters were significantly different between the usualmanagement grou versus the camel milk grou: fasting blood sugar (227.2 ± 17.7 vs. 98.9± 16.2 mg/dl) and HbA1c (9.59±2.05% vs. 7.16± 1.84%). They concluded that, as an adjunct to standard management, daily ingestion of camel milk can aid metabolic control in young tye 1 diabetics, can boost endogenous insulin secretion Control Control Treatment Fig. (1): HbA 1c levels of tye 1 diabetic atients in the treatment and control grous. HbAlc (%) Baseline 3 months 6 months Treatment Fig. (2): HbA 1c levels of tye 2 diabetic atients in the treatment and control grous. In KSA, Al-Numair [11] reorted that 250mL of camel milk administered to diabetic rats result in decreased their glucose level. Moreover, in India, Agrawal et al., [12] reorted a significant decrease in mean blood glucose among tye 1 diabetic atients who received camel's milk in addition to the usual care for 2 years (i.e., from ± 19 mg/dl to 93.16± 17.06mg/dL) and a significant decrease in mean hemoglobin A1c levels among tye 1 diabetic atients who received camel s milk in addition to the usual care for 2 years (i.e., from 7.81 ± 1.39% to 5.44±0.81%). Agrawal et al., [5] exlained these findings by that camel milk ossesses insulin-like activities, which decrease the requirement of exogenous insulin in tye 1 diabetes atients. Moreover, exerimentally, Hassan and Bayoumi [13] roved a significant hyoglycemic effect for camel milk that would alleviate diabetes. Malik et al., [14] ut several hyotheses that would exlain these findings: Insulin in camel milk

6 58 Effect of Camel s Milk Intake on Control of Diabetes ossesses secial roerties that makes absortion into circulation easier than insulin from other sources or cause resistance to roteolysis; camel insulin is encasulated in nanoarticles (liid vesicles) that make ossible its assage through the stomach and entry into the circulation; insulin in camel milk is resent in nanoarticles caable of transorting this hormone into the bloodstream; and camel milk contains insulin-like small molecule substances that mimic insulin interaction with its recetor. However, to rove or disrove any of the above mentioned hyotheses necessitates the conduction of further research studies and exeriments that would ultimately lead to the reason why the intake of camel s milk by diabetics is beneficial. El-Said [15] reorted that the histoathological evaluations of rabbits receiving camel milk demonstrated regeneration in ß cells and the islets of Langerhans. Results of the resent study revealed significantly ositive correlation between age of atient and blood glucose levels among diabetic atients in the treatment grou (Table 5-A). Moreover, there were significantly ositive correlation between both age of atient and duration of diabetes with different HbA 1c levels among diabetic atients in the treatment grou (Table 5-B), indicating higher (i.e., worse) treatment resonse among older atients and also with more disease duration. These findings were exlained by Ogilvie [16], who noted that reduced roortion of functioning islets among diabetics by time imlies a numerical reduction of the islets, i.e., atrohy and disaearance of some islets. A diminution in mean size of the islets is noted in roortion to the duration of the disease. The first five years were the eriod during which the resent chronic diabetics showed the greatest reduction in weight of their islet tissue. A recent exerimental study confirmed the antihyerglycemic effects attributed to camel milk fed diabetic rats. Camel milk intake can revent organ damages associated with DM [17]. Moreover, sustained reductions in hyerglycemia decrease the risk of develoing microvascular comlications [10]. So, it can be assumed that early administration of camel s milk to diabetics may minimize diabetesrelated comlications and may revent develoment of diabetes if administered to re-diabetics. This study revealed that few cases reorted some minor side effects, e.g., mild distension (6.7%), being not tasty (6%) and the occurrence of transient diarrhea (3.3%). All these side effects were temorary and easily managed and did not lead to any interrution of camel s milk intake. This finding is in agreement with that of Al- Wabel et al., [18], who clearly demonstrated that oral administration of camel s milk is easily tolerated and can offer a rotective effect against gastric damage. This study revealed that the twice weekly intake of 250mL camel s milk by diabetic atients is not quite costly. The total cost for camel s milk rovision to 150 diabetic atients in the treatment grou twice weekly for 6 months was 36,000 SR (equivalent to 9600 US$), i.e., the total cost/atient/month is less than 11 US$. In conclusion, the twice weekly intake of 250mL camel s milk by diabetic atients (regardless of their diabetes tye) for at least 6 months is accomanied by significant imrovements in blood sugar and glycemic control. This imrovement is not sex-deendent. However, it is age- and duration of disease-deendent. The later the start of camel s milk intake is, the less the exected imrovement. The dosage and frequency of camel s milk intake by our diabetic atients was emirically decided. Future studies are needed to quantify the exact dosage and frequency of intake in diabetic atients with different tyes and different disease severity. Moreover, further biochemical and harmacological studies are needed to exlain the exact mechanism by which these observed imrovements in diabetes control occur and the otimal dose of camel s milk to be administered to diabetic atients. Other studies are needed to determine its imact uon diabetes-related comlications and morbidities, e.g., retinoathy, neuroathy, etc. Additional rosective randomized and controlled studies are needed to exlore the ossible role of camel s milk intake in reventing the occurrence of frank diabetes among re-diabetics and those at high risk of develoing diabetes (e.g., obese subjects with strong ositive family history of diabetes). References 1- WILD S., ROGLIC G., GREEN A., SICREE R. and KING H.: Global revalence of diabetes estimates for the year 2000 and rojection for Diabetes Care, 27 (5): , 2004.

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