Vitamin A Deficiency

white maize and a corn oil capsule

orange maize and a corn oil capsule

white maize and a vitamin A capsule

Center for Human Nutrition

Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women

Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women

Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)

Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)

Plasma retinol concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)

University of California, Davis

Johns Hopkins University

Tropical Diseases Research Centre, Zambia

56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber

56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars

47g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster

Peak Rise of Blood Glucose

Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber

Test Cluster

Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals

Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals: A Randomized, Cross-over Study

PepsiCo Global R&D

Participants in the active group received the 'pharmacist standard counseling' plus the 'pharmaceutical care service' designed by the research group. Both services were delivered by one female clinical pharmacist who has a Master's degree in pharmaceutical sciences, 5-year work experience in community pharmacies, and comprehensive knowledge of PCOS. The time it took to deliver the counseling and education to each participant in the active group was formally assessed. This time assessment excluded data collection and questionnaire filling time (which was planned to take around 15 min).
Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise.

Participants in the control group received the usual care only which is the 'pharmacist standard counseling' involved dispensing the prescribed medication (delivered by the pharmacist in charge), counseling on how to take the dispensed medications, and a brief reply to questions if asked by the participants. The 'pharmacist standard counseling' followed what was normally delivered to females with PCOS by pharmacists working at community pharmacies in both countries. This 'pharmacist standard counseling' was established based on what was observed and reported by the project research team after viewing the usual pharmacists' interaction with females with PCOS for two weeks in each country before the start of the study.
Participants in the control group were informed that the educational intervention (the pharmaceutical care service) will be delivered to them after the end of the study (for ethical reasons).

Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise.

Polycystic Ovary Syndrome

The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym.
The 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day.
The 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition.
The 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long-term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects.

The PCOS pharmaceutical care service

Five branches of Pharmacy 1

Almazra pharmacy

Alwafaa pharmacy

Kinda Pharmacy

The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome

The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome Associated Factors Amongst Females in Jordan and Syria

Anxiety prevalence assessment using the Beck Anxiety Inventory. The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.

Depression prevalence assessment using the Beck Depression Inventory. The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.

Levels of Anxiety severity and mean score assessment were done by the Beck Anxiety Inventory.
The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.

Levels of Depression severity and mean score assessment were done by the Beck Depression Inventory.
The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.

Quality of Life assessment using the polycystic ovary syndrome health-related QOL questionnaire (PCOSQ).
It has a 30 questions about symptoms related to menstruation and mood. It can identify seven factors affecting the QOL in PCOS women including: emotional disturbance, hirsutism, weight concerns, infertility, menstrual symptoms, menstrual predictability and acne. The QOL was analyzed individually as a continuous scale out of seven to assess the QOL in patients (the higher the score is, the better the QOL is). After that, each question of the 30 questions included in the PCOSQ questionnaire was analyzed, and the mean score within each question was obtained and compared between baseline and follow-up. After that, each domain included in the QOL questionnaire was analyzed individually. Mean score of each domain was obtained and compared between baseline and follow-u to assess the impact of lifestyle modifications on that domain.

Systolic and diastolic blood pressure measurements were measured using the right arm, twice after a 10-min rest and averaged by using the gold standard, mercury sphygmomanometers

Blood Glucose levels assessment using the Multi-parametric device.

Blood Cholesterol levels assessment using the Multi-parametric device.

Blood Triglycerides levels assessment using the Multi-parametric device.

the Body Mass Index was calculated for each participant depending on their weight and hight.

smokers participants recorded the number of cigarettes smoked per day.

Applied Science Private University

Participants in the active group received the usual care delivered at the community pharmacies at both countries plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist, an experienced female with extensive knowledge on PCOS. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise. Participants in the control group received the usual care only and did not receive the pharmaceutical care service.
Following the intervention, both groups were followed up for four months and re-interviewed at the community pharmacy.

The study is a single-blinded randomized controlled trial. The patients 'study groups were only known for the clinical pharmacist.

Half of the group to receive Juice A, a novel juice flavor.

Half of the group to receive Juice B, a novel juice flavor different from Juice A.

Feeding Behavior

Inhibition (Psychology)

Subjects to be given juice daily for 3 weeks.

Juice A

Juice B

Specificity of Flavor-Nutrient Learning: An fMRI Experiment

The juice fMRI paradigm assessed evoked blood oxygen level dependent (BOLD) response to receipt of both juices and a tasteless solution, and logo-elicited anticipation of both juices and tasteless solution.
The paradigm was controlled by in-house scripts written in MATLAB (Mathworks, Inc., Natick, MA). The visual stimuli were two juice logos, a tasteless logo, and a fixation cross. Each logo (4 seconds) signaled impending delivery of 0.5 mL of the associated juice/tasteless over 4 seconds, with the fixation cross otherwise presented. Participants were visually instructed on when to swallow. A jitter ranging from 5 to 13 (x̅ =8) seconds followed each trial. In total, the participants were presented 27 repeats of the events of interest over 3, 12 min runs.

The primary objective of the behavioral impulsivity task was to examine motor disinhibition as represented by response time to the beverage logos and control logos. Participants were instructed to respond as quickly and accurately as possible with a keyboard press when shown the target logo, but withhold their responses during presentation of other logos. Participants performed the task twice, each time depicting one of the beverage logos as the 'target' logo at both the pre- and post-intervention assessments. The order of which logo was the 'target' logo was in a counterbalanced. Each task consisted of 48 trials. Stimuli were presented and reaction times, commission and omission errors were recorded using the Presentation software package (Version 9, Neurobehavioral Systems, Davis, CA). Change in response time is calculated as a difference between baseline and post-intervention assessment average response time across 48 trials.

The secondary objective of the behavioral impulsivity task was to examine error rate in response to the beverage logos and control logos. Participants were instructed to respond as quickly and accurately as possible with a keyboard press when shown the target logo, but withhold their responses during presentation of other logos. Participants performed the task twice, each time depicting one of the beverage logos as the 'target' logo at both the pre- and post-intervention assessments. The order of which logo was the 'target' logo was in a counterbalanced. Each task consisted of 48 trials. Stimuli were presented and reaction times, commission and omission errors were recorded using the Presentation software package (Version 9, Neurobehavioral Systems, Davis, CA). Change in error rate is calculated as a difference between baseline and post-intervention assessment total number of commission and omission error across 48 trials.

All visual analog scales were presented on a computer screen and completed one at a time. If the scale was assessing response to taste, the participant consumed a small amount of the beverage and completed the associated scales. Perceived pleasantness of, and desire to consume the two juices was measured using adapted labeled hedonic scales at pre-/post-intervention. Pleasantness was phrased 'How pleasant is this taste' and anchored by (-100) 'most unpleasant imaginable' to (100) 'most pleasant imaginable', and 'neutral' (0) in the middle. Desire followed a similar pattern using 'desire to consume' as the phrasing. Pleasantness and desire of the assigned juice was also evaluated at the 9 intervention assessments. Perceived hunger was assessed via cross-modal visual analog scales, anchored by (-100) 'I am not hungry at all' to (100) 'I have never been more hungry'. The change score was calculated from the slope of ratings plotted by time.

The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome). The change was calculated as the difference between scores at Baseline and Post-Intervention Assessment.

The Food Frequency Questionnaire (FFQ) is a self-reported checklist of 76 foods and beverages with a frequency response section. Subjects report generally how often each item was consumed over a two-week period of time. The six possible responses are 1= never in the last two weeks, 2= 1-3 times in the last 2 weeks, 3= 4-6 times in the last 2 weeks, 4= 7-9 times in the last two weeks, 5= 10-13 times in the last 2 weeks, 6= daily or more in the last two weeks. Responses information is used to estimate daily caloric intake (number of kcal) and macronutrient content (percent calories from carbohydrate/fat/protein). Food pattern is assessed as an aggregate of these measures. Changes in food pattern will be assessed as a difference from baseline to post-intervention assessment.

The Food Craving Inventory is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Subjects rate how often they have experienced a craving for each food on a 5-point frequency scale, where 1=never, 2=rarely (once or twice), 3=sometimes, 4= often, 5= always/almost every day. Food craving score is calculated as a total sum, and the change score is calculated from the difference between baseline to post-intervention assessment.

The Power of Food scale assesses reported appetitive drive, food reward responsivity, sensitivity to food cues in the environment, and the frequency of food-related thoughts. The 21-item scale prompts subjects to rate how much they agree with statements about hedonic hunger on a 5-point scale, where 1=do not agree at all, 2=agree a little, 3=agree somewhat, 4=agree, and 5=strongly agree. The change in total PFS score will be calculated from the difference between baseline to post-intervention assessment.

The Yale Food Addiction Scale (YFAS) was designed to identify participants who exhibit signs of possible food addiction to specific foods. The 9-item questionnaire is based on substance dependence criteria in the DSM-IV-TR, as well as on scales that have been used to assess behavioral addictions. Subjects rate how often they have experienced a possible food addictive behavior on a 5-point frequency scale, where 0=never, 1=once a month, 2=2-4 times per month, 3= 2-3 times per week, 4= 4+ times per week. The change in total score is calculated from the difference between baseline to post-intervention assessment.

University of North Carolina, Chapel Hill

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Cardiovascular Diseases

Coronary Disease

Heart Diseases

Myocardial Ischemia

dietary supplements

fatty acids, omega-3

diet, fat-restricted

Do Fish Oils Prevent Restenosis Post-Coronary Angioplasty?

National Heart, Lung, and Blood Institute (NHLBI)

The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.

The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.

Concussion

Mild Traumatic Brain Injury

Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.

Docosahexaenoic acid (DHA)

Sports Medicine at Texas Scottish Rite Hospital for Children

DHA For The Treatment of Pediatric Concussion Related to Sports Injury

Docosahexaenoic Acid (DHA) For The Treatment of Pediatric Concussion Related to Sports Injury

Determine the willingness of patients to be randomized, the expected rate of enrollment based on the clinic population, and protocol adherence of enrolled study participants.

Time to clearance to return to play (in days). Time to clearance to return to play was chosen as a clinically significant measurement for medical professionals in the sports medicine field. The investigators will determine clearance for return to full competitive game play (Stage 6 of graduated return to play protocol) according to Consensus Statement guidelines and following the law in Texas, House Bill 2038. Criteria for return to play include complete clinical recovery from the concussion including returning to baseline symptoms, exam and neurocognitive function and successful completion of a gradual return to play progression. We hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play.

Improvement in balance impairment associated with the injury, as assessed by the Balance Error Scoring System (BESS) which is a component of the Sport Concussion Assessment Tool 3 (SCAT-3). We hypothesize a shorter time to resolve balance disturbance associated with the treatment of DHA.