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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Capsule | Placebo Comparator | Participants assigned to this group will receive placebo capsules identical in appearance to EMIQ capsules. |
|
| EMIQ Capsule | Experimental | Participants assigned to this group will receive EMIQ capsules identical in appearance to placebo capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 280mg placebo capsule containing only maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Fat | Whole body fat measured by both dual-energy X-ray absorptiometry (DXA) and skin fold thickness | Change from baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropomorphic Measure I | Body weight | Change from baseline after 4 weeks, after 8 weeks and after 12 weeks |
| Anthropomorphic Measure II | Waist/Hip circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohsen Meydani, DVM, PhD | USDA Human Nutrition Research Center on Aging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts | 02111 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2018 | Sep 18, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2018 | Sep 3, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| EMIQ | Dietary Supplement | 280mg placebo capsule containing 180 mg EMIQ and 100mg maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks |
|
| Change from baseline at 12 weeks. |
| Metabolic Syndrome Measure I | Triglycerides | Change from baseline at 12 weeks. |
| Metabolic Syndrome Measure II | Total Cholesterol | Change from baseline at 12 weeks. |
| Metabolic Syndrome Measure III | HDL | Change from baseline at 12 weeks. |
| Metabolic Syndrome Measure IV | LDL | Change from baseline at 12 weeks. |
| Metabolic Syndrome Measure V | Insulin | Change from baseline at 12 weeks. |
| Metabolic Syndrome Measure VI | Adiponectin. | Change from baseline at 12 weeks. |
| Total protein | Total protein measured in urine. | Change from baseline at 12 weeks. |
| Glucose | Glucose measured in urine. | Change from baseline at 12 weeks. |
| Urobilinogen | Urobilinogen measured in urine. | Change from baseline at 12 weeks. |
| Bilirubin | Bilirubin measured in urine. | Change from baseline at 12 weeks. |
| Urine acidity | Hydrogen ion concentration (pH) measured in urine. | Change from baseline at 12 weeks. |
| Ketones | Ketones measured in urine. | Change from baseline at 12 weeks. |
| Occult Blood | Occult blood count measured in urine. | Change from baseline at 12 weeks. |
| Resting Metabolic Rate | Used to determine rate of calories burned per day. | Change from baseline at 12 weeks. |
| Nutritional Intake | Nutritional intake measures assessed via 3 sets of 3 24-hour dietary recalls by phone. | Measures taken at baseline, week 6 and week 12. |
| Three Factor Eating Questionnaire | Dietary restraint, disinhibition and hunger measured by Three Factor Eating questionnaire. | Changes from baseline after 12 weeks. |
| Food Cravings | Changes in food cravings assessed by Food Cravings-Trait questionnaire | Changes from baseline after 12 weeks. |
| Physical Activity | Physical activity tracked and measured with the Stanford 7-Day Physical Activity Recall questionnaire. | Changes from baseline at 4, 6 8 and 12 weeks. |
| Mental Health | Depression assessed by the Beck Depression Inventory. | Change from screening to end of study (approximately 14 weeks) |
| Heart Health | Electrocardiogram (EKG) will be used to assess changes to heart rhythm. | Change from baseline at 4 weeks. |
| Liver Health Marker I | Serum glutamic pyruvic transaminase (SGPT) | Change from baseline after 4 weeks, after 8 weeks and after 12 weeks. |
| Liver Health Marker II | Serum glutamic oxaloacetic transaminase (SGOT). | Change from baseline after 4 weeks, after 8 weeks and after 12 weeks. |
| Kidney Health Measure I | Blood urea nitrogen (BUN). | Change from baseline after 4 weeks, after 8 weeks and after 12 weeks. |
| Kidney Health Measure II | Creatinine concentration. | Change from baseline after 4 weeks, after 8 weeks and after 12 weeks. |
| Kidney Health Measure III | Glomerular filtration rate (GFR). | Change from baseline after 4 weeks, after 8 weeks and after 12 weeks. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |