Overweight Clinical Trial
Official title:
Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
The purpose of this clinical study is to determine the effect and safety of long-term intake of enzymatically modified isoquercitrin (EMIQ), a natural plant product on body fat loss in obese and overweight individuals.
This study is being conducted to assess the effect of supplementation with Enzymatically
Modified Isoquercitrin (EMIQ) vs. placebo on measures of total body fat in overweight and
obese adults. Participants will visit the HNRCA on 5 different dates.
Visit 1: Participants will receive materials and instruction for completing 24-hour dietary
recalls to be completed by phone a week prior to the next visit.
Visit 2: Overnight fasted participants will arrive to the Human Nutrition Research Center on
Aging (HNRCA). Vital signs, and EKG measure of heart rhythm, scrub weight and height will be
obtained. Blood samples will be collected. Several baseline measurements will be performed
during this visit including: lipid profile, insulin test, adiponectin, a urine dip stick,
skinfold thickness and waist/hip circumference, resting metabolic rate (RMR), and DXA measure
of total body fat. A three factor eating questionnaire, food craving questionnaire, and the
Stanford 7-Day Physical Activity Recall (PAR) will be administered to assess volunteer's
dietary inhibition, restraint, hunger, cravings and physical activity level. EMIQ and placebo
capsules, compliance calendar, and instructions will be dispensed to participants by nursing
staff.
Visit 3: Overnight fasted participants will arrive to HNRCA four weeks from the last visit.
Participants will be asked to return their unused supplements as well as their compliance
calendar. Vital signs, scrub weight and changes to volunteer health, medication and
eligibility status will be assessed. Blood samples will be collected. A second EKG will be
performed. The PAR will be administered. Before their next visit, participants will complete
3 24- hour dietary recalls by phone.
Visit 4: overnight fasted participants will arrive to HNRCA four weeks from the last visit.
Participants will be asked to return their unused supplements as well as their compliance
calendar. Vital signs, scrub weight and changes to volunteer health, medication and
eligibility status will be assessed. Blood samples will be collected. The PAR will be
administered. Before their next visit, participants will complete 3 24- hour dietary recalls
by phone.
Visit 5: Overnight fasted participants will arrive to HNRCA four weeks from the last visit.
Vital signs and scrub weight will be assessed. Blood samples will be collected. Final
measurements will be taken during this visit including: routine health screening analysis,
lipid profile, adiponectin, insulin test, a urine dip stick, liver and kidney function (SGOT,
SGPT, BUN, creatinine, and calculated GFR), skin fold thickness, DXA, RMR and waist/hip
circumference. A three factor eating questionnaire, food craving questionnaire, and the PAR
will be administered to assess changes in volunteer's dietary inhibition, restraint, hunger,
cravings and activity level throughout the study.
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