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The purpose of this pilot study is to evaluate the effects of 4 weeks of daily consumption of encapsulated N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) at a dose of 120 mg/d on measures of fat oxidation in women with overweight or obesity. The hypothesis is that fat oxidation at rest (measured via indirect calorimetry) and over a 24 h period (measured via d31-palmitic acid stable isotope tracer) will be higher in the group receiving the active study product compared to the control product at the end of the 4-week consumption period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Treatment | Placebo Comparator |
| |
| Active high dose of plant derived phenolics | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement containing plant derived phenolics | Dietary Supplement | Dietary supplement containing plant derived phenolics |
|
| Measure | Description | Time Frame |
|---|---|---|
| % deuterium (2H) label from oxidation of d31-palmitic acid | Percentage recovery of the deuterium (2H) label from oxidation of d31-palmitic acid to water in urine samples collected | Day 1 and Day 28 (each day measurements are done in multiple timepoints of Hour 0, Hour 3, Hour 4, Hour 8, and Hour 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in indirect calorimetry measures | Resting metabolic rate (RMR; kcals/d) derived from the Weir equation | day 1 and day 28 |
| Change in indirect calorimetry measures | Substrate utilization associated with RMR derived from the Respiratory Exchange Ratio (RER) |
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Inclusion Criteria
Exclusion Criteria
Unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation
Weight loss or gain ≥4.5 kg within 90 days of visit 1 (day -28).
Use of weight loss medications within 90 days of visit 1 (day -28).
Any health condition that would prevent the participant from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history. Health conditions may include history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
Current medical diagnosis of type 1 or type 2 diabetes mellitus.
History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at visit 1.
Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1.
History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer.
Known intolerance or sensitivity to any ingredients in the study products.
Exposure to any non-registered drug product within 30 days prior to visit 1.
Signs or symptoms of an active infection of clinical relevance* within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1.
Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits).
Any condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Recruiting | Addison | Illinois | 60101 | United States |
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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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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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| Microcrystaline cellulose | Dietary Supplement | Microcrystaline cellulose (MCC) |
|
| day 1 and day 28 |
| Change in cardiometabolic parameters | Fasting free fatty acids | day 1 and day 28 |
| Change in cardiometabolic parameters | Fasting NMR lipoproteins | day 1 and day 28 |
| Change in cardiometabolic parameters | Fasting Glucose | day 1 and day 28 |
| Change in cardiometabolic parameters | Fasting Insuline | day 1 and day 28 |
| Change in body weight | Change in body weight measured in scale | day 1 and day 28 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |