Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; EMIQ
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 280mg placebo capsule containing only maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks; 280mg placebo capsule containing 180 mg EMIQ and 100mg maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science