Performing Department
(N/A)
Non Technical Summary
Non-Technical Summary Obesity has become a worldwide problem giving rise to serious health issues such as hypertension, type-2 diabetes, cardiovascular diseases, and certain types of cancer. One third of the adult population in the US is obese and 17% of children suffer from obesity. Fucoxanthin, a marine carotenoid with anti-obesity activity, has potential application as a biofunctional ingredient in food. The objective of this study is to evaluate the anti-obesity effect of fucoxanthin, when supplemented into goat milk yogurt, on weight loss in overweight and obese adults. Yogurt treatments will be supplemented with fucoxanthin at different concentrations (7.5 mg, 11.5 mg, or 15.5 mg/170 g cup of yogurt), and the control yogurt (170 g/cup) will have no fucoxanthin. The yogurt mixes will be heated at 80°C for 30 min, then cooled to 42°C, inoculated with Streptococcus thermophilus and Lactobacillus bulgaricus at 2%, and incubated until pH reaches 4.3- 4.5 (usually in 5 h). The physicochemical characteristics of yogurts and the quantity of fucoxanthin in treatments will be analyzed. Seventy-two volunteers, ages 23-60 years, with a body mass index (BMI) of 25-40 kg/m2 will be recruited for this clinical study. The subjects will be given one serving of control or experimental yogurt per day for 12 weeks. The anthropometric indices (body weight, height, BMI, waist circumference, and hip circumference), body composition, and lipid profile (triglycerides, total cholesterol, HDL, and LDL) of the subjects will be measured. Comparison of data before the initiation of the study and after the ingestion of control and treated yogurts will elucidate the anti-obesity effect of fucoxanthin on human subjects. The development of healthy foods to better serve the nutritional needs of society is in line with the USDA priority area of Diet, Nutrition and Prevention of Chronic Diseases (A1344).
Animal Health Component
33%
Research Effort Categories
Basic
33%
Applied
33%
Developmental
34%
Goals / Objectives
Nutrition plays a significant role in the quality of life as foods have been linked to health and wellness, as well as in the control of obesity. Obesity is associated with some of America's most costly and serious health problems such as type-2 diabetes, cardiovascular diseases, and certain types of cancers (Wan-Loy and Siew-Moi, 2016; Amri and Scheideler, 2017). According to the National Health and Nutrition Examination Survey (NHANES) of 2017-2018, the percentage of obesity for men and women in US adults (aged 20 and over) is 43.0 and 41.9, respectively. The prevalence of obesity among male and female adults in the US is roughly the same and is at an alarming rate according to this survey (Fryar et al., 2020). The medical and economic burden of obesity-related diseases in society amounts to billions of dollars annually. Hence, developing effective preventive measures to reduce obesity and the medical costs of diseases related to it is essential. Nutrition can play a major role in reducing these lifestyle-related diseases and it is highly desirable to find safe and effective bio-functional ingredients in food to mitigate these health-related issues through diet (Kuipers et al., 2011).Since obesity continues to be an important target for effective preventive therapies of several diseases, and to ease the medical and economic burden of these obesity-related diseases in the developed world (Shao et al., 2017), this research proposal will assess the potential anti-obesity effect of fucoxanthin, a fat-soluble antioxidant carotenoid, in goat milk yogurt. This proposal examines the formulation and effects of an anti-obesity bioactive ingredient in goat milk yogurt that will support a healthier serving of dairy food to the general population.Texas is one of the largest goat-producing states and is the home to the International Goat Research Center at Prairie View A&M University (PVAMU). The center was developed through legislative efforts and is mandated to build the goat research program and identify the needs of the clientele in this state. Dairy goat numbers have increased in the southern region of the U.S. because this area with large grazing lands is more suitable for goat rearing. Additionally, this area has the greatest demand for goat products due to the growth in population diversity and differences in their cultural heritage (Marsh, 2021).For small and limited-resource farmers dairy goat production is a viable alternative to dairy cattle rearing, which requires more capital investment. To serve the limited resourceproducers, some 1890 schools have performed research that encourages dairy goat production as an alternative animal production system. Prairie View A&M University (Historically Black College and University) is one of the 1890 Universities that has developed a dairy goat research program with excellent expertise in all aspects of dairy goat management, breeding, physiology, and nutrition. With this priority in mind, the Food System Group of the College of Agriculture, Food and Natural Resources (CAFNR) at PVAMU proposes to develop and evaluate a value-added goat milk yogurt that will have an anti-obesity ingredient and promote healthy lifestyles in the society.Objectives: The objective of this project is to evaluate the anti-obesity effect of fucoxanthin as a bio-functional ingredient, when supplemented into goat milk yogurt, on weight loss and other body parameters in overweight and obese human subjects. Thus, this study will be conducted to elucidate the effects of fucoxanthin supplemented goat yogurt on anthropometric indices (weight, total body fat, subcutaneous fat, body mass index [BMI], waist circumference [WC], and hip circumference [HC]), on overweight and obese human subjects over a 12-week period compared to a control group receiving yogurt without fucoxanthin. Successful implementation of this project will support the USDA-NIFA Program priority area of Diet, Nutrition, and the Prevention of Chronic Diseases.
Project Methods
Yogurt Preparation: Goat milk yogurt will be manufactured according to our recent publication (Nunez et. al., 2023). The yogurt mix will be supplemented with fucoxanthin at concentrations of 0.044 mg/g (7.5 mg/170 g cup of yogurt), 0.068 mg/g (11.5 mg/170 g of yogurt) or 0.091 mg/g (15.5 mg/170 g). The control treatment will have 170 g of yogurt without fucoxanthin. The total concentrations of fucoxanthin ingested from the yogurts in this study will be either 7.5, 11.5 or 15.5 mg/day compared to Abidov et al. (2010) who gave a dose of 7.2 mg/day of fucoxanthin capsules, in a restricted diet study. The quantity of fucoxanthin in yogurts will be determined according to the HPLC technique in our articles (Nuñez de González, et al., 2021 and 2023). Both control and fucoxanthin supplemented yogurts will be prepared biweekly at the International Goat Research Center milking parlor and will be distributed to the volunteer human subjects on a weekly basis.Sensory Analysis: A trained sensory panel will evaluate the final yogurt samples at our sensory laboratory at the CAFNR. The panelists will be selected and trained from the University community according to the procedure of Meilgaard et al. (2007). Additionally, the consumer acceptability of the control and treatment yogurts will be evaluated by a group of participants (80-100) according to the method of Meilgaard et al. (2007). If yogurts have no objectionable attributes and no modification in product development is needed, then they will be used for the study.Participants in the Clinical Trial: The protocol approval for this study will be obtained from the Institutional Review Board of the University and each subject will sign a written consent form (a legal instrument drawn by an attorney) before the initiation of any clinical trial. If a subject requests to discontinue the study or the appearance of an adverse event occurs, the subject will be removed from the study. An adverse event in this study is defined as symptoms or signs resulting from ingesting the treated yogurts that made the subject feel unpleasant. A decision about whether to continue the study will be made in consultation with the medical doctor in charge (Dr. Glen Berry from the University Health Center). Based on the review of literature (Abidov et al., 2010; Hitoe and Shimoda 2017), it is not expected to have any adverse effect from the intervention of fucoxanthin in the diet. After a thorough interview 72 male and female subjects, with a body mass index (BMI; 25-40 kg/m2) will be recruited for this clinical trial from the community. Additionally, the subjects will be given some lectures on basic nutrition, energy intake and expenditure during daily activities. It will be emphasized to subjects to comply with the study rules and restrictions avoiding any variability in the study. The subjects will be instructed to avoid irregular lifestyles and continue without changing their usual dietary regimen. Eighteen (n = 18) subjects are randomly assigned to receive either the control or treatment yogurts. Seventy-two human subjects will be assigned to a calorie-restricted diet intervention with total food intake reduction to account for the 1 serving of yogurt per day.Total Energy Expenditure and Calorie Restriction: The study participants will be entered into a 1-week run-in period to obtain detailed information about their dietary intakes and physical activities to aid in proper food record keeping and design of calorie restrictions as described below. The Mifflin-St Jeor equation [Men = (10 x weight in kg) + (6.25 x height in cm) (5 x age in years) +5; Women = (10 x weight in kg) + (6.25 x height in cm) - (5 x age in years) - 161] will be used to determine the resting energy expenditure (REE) of study participants. This equation is supported by most research to assess REE in overweight or obese adults (Academy of Nutrition and Dietetics, 2015). The calculated REE of each participant will be multiplied by the activity factor based on their physical activity levels [sedentary = 1 - <1.4; low active = 1.4 - <1.6; active = 1.6 - < 1.9; and very active = 1.9 - < 2.5] to attain their total energy expenditure (TEE). Once the TEE is known, the Registered Dietitian and Co-PI, Dr. Janet Antwi will instruct the participants to create a calorie deficit of at least 500 kcal a day to facilitate weight loss over the 12-week period. Participants will be given a 5% total body weight loss goal. Pedometry will be used to measure physical activity levels in real-time. Pedometers correlate strongly with uniaxial accelerometers, and directly observed duration of activities (Rachele et al., 2012; Bassett and Strath 2002). Participants will be required to wear pedometers during physical activity for the entire period of the project to record the mode, duration, frequency, and intensity of the physical activities. Subjects will also be contacted by telephone twice a week to assess their compliance with the diet-restricted lifestyle.Total Calorie Intake Determination and Physical Activity Recommendation: Participants will be instructed to record all daily food intake and will be taught the common food measurement procedures as well as how to submit electronically their daily food records to researchers. Dr. Janet Antwi will perform dietary analysis using the Nutritionist Pro™ nutrition analysis tool to determine daily total calorie intake and ensure that participants maintain the calorie deficit requirement. The calorie deficit will be created by subtracting TEE from the energy intake assessed by the analysis of daily calorie intake. The dietitian will provide counseling to assist participants in maintaining the requirements during the study. Participants will be advised to increase the amount of energy expended through physical activity by walking for at least 30 minutes, 5 days/week over the 12-week period. Therefore, the caloric deficit of 500 kcal and increase in physical activity recommendation is what will be used, which is the standard regimen recommended by the Dietary Guidelines for Americans and is consistent with literature to promote weight loss in overweight and obese individuals. The differences in weight loss between the subjects who received the control yogurt and those who received the treated yogurts will be statistically determined to evaluate the effectiveness of fucoxanthin as an ant-obesity bioactive compound.Measurements: The baseline characteristics of all subjects will be determined at the initiation of the study. Subjects' weights, heights, waists, and hip circumferences will be measured as well as their vital signs at weeks 0, 6, and 12. Total body fat, subcutaneous fat, and body fat across five body segments, and BMI will be determined. Likewise, total amount of lean muscle tissue, visceral fat (inside abdominal cavity), and trunk fat will be measured by dual energy x-ray absorptiometry (DEXA) at weeks 0, 6, and 12 at the Health Center. Likewise, blood samples will be collected from each subject at weeks 0, 6, and 12, and the chemistry profile of blood, lipid profile, and complete blood counts will be obtained (from a contracted Quest Diagnostics Laboratory, Houston, TX). The secondary outcomes such as blood pressure, pulse rate, and hematological parameters such as red blood cells, leukocytes, and platelet counts will also be studied at the University Health Center. Physicochemical Analyses of Yogurt: The chemical composition of yogurts will be determined in triplicate according to the AOAC (2005) procedures. The pH, titratable acidity, color intensity, syneresis, texture, lipid oxidation, and quantification of fucoxanthin in yogurts will be performed according to the techniques used in our article (Nuñez de González et. al., 2023).Statistical analysis. An appropriate statistical model in consultation with biostatistician will be selected for analysis of study data.