Clinical trial NCT02818699: Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
Official title: Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male or female age 18-65 years.
* Premenopausal female with regular menstrual cycle or post-menopausal female with cessation of menstrual cycle for a minimum of 6 months.
* BMI in the range of 28.0-35.0
* Beck Depression Inventory Score less than 20.
* Fluency in spoken or written English.
* Willingness to be randomized to take EMIQ or placebo.
* Must weigh at least 164lbs

Exclusion Criteria:

* Any major illness or condition that may interfere with study outcomes at the discretion of the study physician.
* Diabetes Type I \& Type II, or use of any pharmacological treatment for diabetes.
* Use of medications that interfere with energy metabolism
* Receiving hormone therapy growth hormone, testosterone, or estrogen with the exception of hormone contraceptives.
* GI diseases, conditions or medications known to influence GI absorption including active peptic ulcer disease or inflammatory bowel disease such as ulcerative colitis, Crohn's disease, celiac disease, chronic diarrhea or constipation.
* Undergone gastric bypass or other bariatric weight loss procedure.
* Lipid lowering medications such as: bile acid sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.), cholesterol absorption inhibitors (Ezetimibe-Zetia), and fibrates (Gemfibrozil, Clofibrate, Fenofibrate, Triclor). Exceptions to this exclusion are 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase or Statins).
* On or planning to participate in a weight loss program.
* Weight loss or weight gain greater than 10 lbs in the past 6 months.
* History of eating disorders, anorexia, bulimia, or binge-eating in the past 5 years.
* Participation in any regular endurance exercise: running, biking or aerobics (except walking) greater than 2.5 hours per week, or resistance training greater than once per week.
* Regular use of acid lowering medications (greater than 3 times per week) such as antacids, proton pump inhibitors (PPIs), or H2 blockers.
* Unstable thyroid disease.
* Psychiatric disorders including schizophrenia, bipolar, major depression or psychosis.
* Antidepressant medication: selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, or tricyclic antidepressants (TCAs).
* Cancer of any type (except for non-melanoma skin) in the past 5 years.
* Use of chemotherapeutic agents.
* Pregnancy, planning to become pregnant during the study period, or breastfeeding.
* Unwilling to use effective birth control during study.
* History of bilateral mastectomy with nodal dissection.
* Alcohol use, on average, greater than 3 servings per day, 20 servings per week (Serving size: 12oz beer, 4oz wine, 2oz hard liquor), or self-reported binge drinking.
* Uncontrolled hypertension (HTN) determined at the discretion of the study MD or registered nurse (RN). HTN medications allowed in the study: angiotensin converting enzyme (ACE) inhibitors, calcium channel blockers, and diuretics.
* Medications for chronic obstructive pulmonary disease (COPD) or kidney disease.
* α-adrenergic or β-adrenergic blockers (oral or ocular) and diuretics.
* Renal or chronic kidney disease due to any condition, renovascular disease, or dialysis.
* Chronic liver disease such as hepatitis B, hepatitis C, or cirrhosis.
* Cardiovascular disease including: myocardial infarction, cerebrovascular disease (CVA), coronary artery bypass graft, stenosis greater than 50%, angina, coronary artery disease (CAD), congestive heart failure (CHF),peripheral vascular disease (PVD) or dysautonomia.
* History of autoimmune diseases such as rheumatoid arthritis, lupus, multiple sclerosis, vitiligo, or psoriasis.
* HIV or AIDS based on self-report.
* Steroid use with the exception of over-the-counter topical and nasal steroids such as Flonase.
* Allergy medication or regular antihistamine use.
* Seizure disorders. Acceptable if managed with medication and free of seizure activity for 5 years.
* Smoking or the use of nicotine replacement products in the past 6 months.
* Use of dietary supplements containing vitamins (except Calcium and Vitamin D), minerals, herbal or plant-based preparations, fish oil or homeopathic remedies during study participation unless willing to discontinue prior to enrollment.
* Current participation in another research study.
* Non-English speaking.
* No social security number.
* Participation in another research study.

Primary outcomes:
measure: Body Fat
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Anthropomorphic Measure I
timeFrame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks
measure: Anthropomorphic Measure II
timeFrame: Change from baseline at 12 weeks.
measure: Metabolic Syndrome Measure I
timeFrame: Change from baseline at 12 weeks.
measure: Metabolic Syndrome Measure II
timeFrame: Change from baseline at 12 weeks.
measure: Metabolic Syndrome Measure III
timeFrame: Change from baseline at 12 weeks.
measure: Metabolic Syndrome Measure IV
timeFrame: Change from baseline at 12 weeks.
measure: Metabolic Syndrome Measure V
timeFrame: Change from baseline at 12 weeks.
measure: Metabolic Syndrome Measure VI
timeFrame: Change from baseline at 12 weeks.
measure: Total protein
timeFrame: Change from baseline at 12 weeks.
measure: Glucose
timeFrame: Change from baseline at 12 weeks.
measure: Urobilinogen
timeFrame: Change from baseline at 12 weeks.
measure: Bilirubin
timeFrame: Change from baseline at 12 weeks.
measure: Urine acidity
timeFrame: Change from baseline at 12 weeks.
measure: Ketones
timeFrame: Change from baseline at 12 weeks.
measure: Occult Blood
timeFrame: Change from baseline at 12 weeks.
measure: Resting Metabolic Rate
timeFrame: Change from baseline at 12 weeks.
measure: Nutritional Intake
timeFrame: Measures taken at baseline, week 6 and week 12.
measure: Three Factor Eating Questionnaire
timeFrame: Changes from baseline after 12 weeks.
measure: Food Cravings
timeFrame: Changes from baseline after 12 weeks.
measure: Physical Activity
timeFrame: Changes from baseline at 4, 6 8 and 12 weeks.
measure: Mental Health
timeFrame: Change from screening to end of study (approximately 14 weeks)
measure: Heart Health
timeFrame: Change from baseline at 4 weeks.
measure: Liver Health Marker I
timeFrame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
measure: Liver Health Marker II
timeFrame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
measure: Kidney Health Measure I
timeFrame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
measure: Kidney Health Measure II
timeFrame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
measure: Kidney Health Measure III
timeFrame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: USDA Human Nutrition Research Center on Aging
name: Mohsen Meydani, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
References: