Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects

NCT02818699 | Completed

• 1 other identifier: 2885
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Overweight

Outcome Measures

Primary Outcomes (1)

• Body Fat

  Whole body fat measured by both dual-energy X-ray absorptiometry (DXA) and skin fold thickness

  Change from baseline at 12 weeks

Secondary Outcomes (27)

• Anthropomorphic Measure I

  Change from baseline after 4 weeks, after 8 weeks and after 12 weeks

• Anthropomorphic Measure II

  Change from baseline at 12 weeks.

• Metabolic Syndrome Measure I

  Change from baseline at 12 weeks.

• Metabolic Syndrome Measure II

  Change from baseline at 12 weeks.

• Metabolic Syndrome Measure III

  Change from baseline at 12 weeks.

Study Arms (2)

Placebo Capsule

PLACEBO COMPARATOR

Participants assigned to this group will receive placebo capsules identical in appearance to EMIQ capsules.

Dietary Supplement: Placebo

EMIQ Capsule

EXPERIMENTAL

Participants assigned to this group will receive EMIQ capsules identical in appearance to placebo capsules.

Dietary Supplement: EMIQ

Interventions

EMIQ DIETARY_SUPPLEMENT

280mg placebo capsule containing 180 mg EMIQ and 100mg maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks

EMIQ Capsule

Placebo DIETARY_SUPPLEMENT

280mg placebo capsule containing only maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks

Placebo Capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohsen Meydani, DVM, PhD

  USDA Human Nutrition Research Center on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 30, 2016
• Study Start: August 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: September 14, 2018
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)