OverweightNCT02818699
Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
A study testing EMIQ in people with Overweight and Obese, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- EMIQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 14 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 38Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
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.
Read the 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.
- Conditions
- Overweight, Obese
- Being tested
- Placebo, EMIQ
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
280mg placebo capsule containing only maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks
EMIQDietary supplement
280mg placebo capsule containing 180 mg EMIQ and 100mg maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Capsule | Placebo comparator | Participants assigned to this group will receive placebo capsules identical in appearance to EMIQ capsules. Receives: Dietary Supplement: Placebo |
| EMIQ Capsule | Experimental | Participants assigned to this group will receive EMIQ capsules identical in appearance to placebo capsules. Receives: Dietary Supplement: EMIQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Whole body fat measured by both dual-energy X-ray absorptiometry (DXA) and skin fold thickness
Measured: Change from baseline at 12 weeks
Secondary outcomes (27)
Anthropomorphic Measure I
Body weight
Measured: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks
Anthropomorphic Measure II
Waist/Hip circumference
Measured: Change from baseline at 12 weeks.
Metabolic Syndrome Measure I
Triglycerides
Measured: Change from baseline at 12 weeks.
Metabolic Syndrome Measure II
Total Cholesterol
Measured: Change from baseline at 12 weeks.
Metabolic Syndrome Measure III
HDL
Measured: Change from baseline at 12 weeks.
Metabolic Syndrome Measure IV
LDL
Measured: Change from baseline at 12 weeks.
Metabolic Syndrome Measure V
Insulin
Measured: Change from baseline at 12 weeks.
Metabolic Syndrome Measure VI
Adiponectin.
Measured: Change from baseline at 12 weeks.
Total protein
Total protein measured in urine.
Measured: Change from baseline at 12 weeks.
Glucose
Glucose measured in urine.
Measured: Change from baseline at 12 weeks.
Urobilinogen
Urobilinogen measured in urine.
Measured: Change from baseline at 12 weeks.
Bilirubin
Bilirubin measured in urine.
Measured: Change from baseline at 12 weeks.
Urine acidity
Hydrogen ion concentration (pH) measured in urine.
Measured: Change from baseline at 12 weeks.
Ketones
Ketones measured in urine.
Measured: Change from baseline at 12 weeks.
Occult Blood
Occult blood count measured in urine.
Measured: Change from baseline at 12 weeks.
Resting Metabolic Rate
Used to determine rate of calories burned per day.
Measured: Change from baseline at 12 weeks.
Nutritional Intake
Nutritional intake measures assessed via 3 sets of 3 24-hour dietary recalls by phone.
Measured: Measures taken at baseline, week 6 and week 12.
Three Factor Eating Questionnaire
Dietary restraint, disinhibition and hunger measured by Three Factor Eating questionnaire.
Measured: Changes from baseline after 12 weeks.
Food Cravings
Changes in food cravings assessed by Food Cravings-Trait questionnaire
Measured: Changes from baseline after 12 weeks.
Physical Activity
Physical activity tracked and measured with the Stanford 7-Day Physical Activity Recall questionnaire.
Measured: Changes from baseline at 4, 6 8 and 12 weeks.
Mental Health
Depression assessed by the Beck Depression Inventory.
Measured: Change from screening to end of study (approximately 14 weeks)
Heart Health
Electrocardiogram (EKG) will be used to assess changes to heart rhythm.
Measured: Change from baseline at 4 weeks.
Liver Health Marker I
Serum glutamic pyruvic transaminase (SGPT)
Measured: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Liver Health Marker II
Serum glutamic oxaloacetic transaminase (SGOT).
Measured: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Kidney Health Measure I
Blood urea nitrogen (BUN).
Measured: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Kidney Health Measure II
Creatinine concentration.
Measured: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Kidney Health Measure III
Glomerular filtration rate (GFR).
Measured: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Jul 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohsen Meydani, DVM, PhD, Principal investigator, USDA Human Nutrition Research Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818699
- Sponsor's protocol ID
- 2885
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2016
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02818699
- Acronym / sponsor ID
- 2885
- Conditions
- Overweight, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Capsule | Placebo comparator | Dietary Supplement: PlaceboParticipants assigned to this group will receive placebo capsules identical in appearance to EMIQ capsules. |
| EMIQ Capsule | Experimental | Dietary Supplement: EMIQParticipants assigned to this group will receive EMIQ capsules identical in appearance to placebo capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo280mg placebo capsule containing only maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks | Dietary supplement | Placebo Capsule |
| EMIQ280mg placebo capsule containing 180 mg EMIQ and 100mg maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks | Dietary supplement | EMIQ Capsule |
Primary outcome
Body Fat
Time frame: Change from baseline at 12 weeks
Whole body fat measured by both dual-energy X-ray absorptiometry (DXA) and skin fold thickness
27 secondary outcomes
Anthropomorphic Measure I
Time frame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks
Anthropomorphic Measure II
Time frame: Change from baseline at 12 weeks.
Metabolic Syndrome Measure I
Time frame: Change from baseline at 12 weeks.
Metabolic Syndrome Measure II
Time frame: Change from baseline at 12 weeks.
Metabolic Syndrome Measure III
Time frame: Change from baseline at 12 weeks.
Metabolic Syndrome Measure IV
Time frame: Change from baseline at 12 weeks.
Metabolic Syndrome Measure V
Time frame: Change from baseline at 12 weeks.
Metabolic Syndrome Measure VI
Time frame: Change from baseline at 12 weeks.
Total protein
Time frame: Change from baseline at 12 weeks.
Glucose
Time frame: Change from baseline at 12 weeks.
Urobilinogen
Time frame: Change from baseline at 12 weeks.
Bilirubin
Time frame: Change from baseline at 12 weeks.
Urine acidity
Time frame: Change from baseline at 12 weeks.
Ketones
Time frame: Change from baseline at 12 weeks.
Occult Blood
Time frame: Change from baseline at 12 weeks.
Resting Metabolic Rate
Time frame: Change from baseline at 12 weeks.
Nutritional Intake
Time frame: Measures taken at baseline, week 6 and week 12.
Three Factor Eating Questionnaire
Time frame: Changes from baseline after 12 weeks.
Food Cravings
Time frame: Changes from baseline after 12 weeks.
Physical Activity
Time frame: Changes from baseline at 4, 6 8 and 12 weeks.
Mental Health
Time frame: Change from screening to end of study (approximately 14 weeks)
Heart Health
Time frame: Change from baseline at 4 weeks.
Liver Health Marker I
Time frame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Liver Health Marker II
Time frame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Kidney Health Measure I
Time frame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Kidney Health Measure II
Time frame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Kidney Health Measure III
Time frame: Change from baseline after 4 weeks, after 8 weeks and after 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen Meydani, DVM, PhD principal investigator
USDA Human Nutrition Research Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMIQ in people with Overweight and Obese, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.