OverweightNCT06548048
Dietary Supplementation on Fat Oxidation
A study testing Dietary supplement containing plant derived phenolics and Microcrystaline cellulose in people with Overweight and Obesity, run by Brightseed at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Dietary supplement containing plant derived phenolics and Microcrystaline cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 31 Dec 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, ≥18 and <50 years of age at visit 1 (day -28).
- Body mass index (BMI) of ≥29.0 kg/m2 to <40.0 kg/m2 at visit 1 (day -28).
- No health conditions that would prevent fulfilling the study requirements as judged by the Investigator on the basis of medical history.
- History of regular menstrual cycles with menses (21-35 d per cycle) for at least 3 months prior to visit 1 (day -28).
- Stable use of non-weight loss (e.g., semaglutide) prescription medications allowed, where stable use is defined as the same class of medication and dose for at least 90 d prior to visit 1 (day -28).
- Willing to discontinue any dietary supplement use (except for conventional once daily vitamin/mineral supplement[s]), for one week prior to visit 2 and throughout the study.
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- Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
- Willing to maintain habitual diet (with the exception of restricted foods/beverages) throughout the study period.
- Willing to use personal web-based device (e.g., smart phone, tablet, or laptop) with operating system (Android version 12.0 or newer; iOS version 16 or newer) capable of downloading the Cronometer app for diet records.
- Willing to adhere to all study procedures and signs forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Who cannot join
- 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.
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- 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.
- If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biofortis
Addison, Illinois, 60101
Chad Cook, 414-882-3279, chad.cook@mxns.com
About this study
Official title: A Randomized, Double-blind, Parallel Study to Examine the Effects of N-trans-caffeoyl Tyramine and N-trans-feruloyl Tyramine Bioactives on Fat Oxidation in Adult Women With Overweight and Obesity
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.
- Conditions
- Overweight, Obesity
- Being tested
- Dietary supplement containing plant derived phenolics, Microcrystaline cellulose
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement containing plant derived phenolicsDietary supplement
Dietary supplement containing plant derived phenolics
Microcrystaline celluloseDietary supplement
Microcrystaline cellulose (MCC)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Treatment | Placebo comparator | Not described Receives: Dietary Supplement: Microcrystaline cellulose |
| Active high dose of plant derived phenolics | Active comparator | Not described Receives: Dietary Supplement: Dietary supplement containing plant derived phenolics |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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
Measured: 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)
Secondary outcomes (7)
Change in indirect calorimetry measures
Resting metabolic rate (RMR; kcals/d) derived from the Weir equation
Measured: day 1 and day 28
Change in indirect calorimetry measures
Substrate utilization associated with RMR derived from the Respiratory Exchange Ratio (RER)
Measured: day 1 and day 28
Change in cardiometabolic parameters
Fasting free fatty acids
Measured: day 1 and day 28
Change in cardiometabolic parameters
Fasting NMR lipoproteins
Measured: day 1 and day 28
Change in cardiometabolic parameters
Fasting Glucose
Measured: day 1 and day 28
Change in cardiometabolic parameters
Fasting Insuline
Measured: day 1 and day 28
Change in body weight
Change in body weight measured in scale
Measured: day 1 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start31 Jul 2024
- Primary completion5 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brightseed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548048
- Sponsor's protocol ID
- BIO-2406
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Study to Examine the Effects of N-trans-caffeoyl Tyramine and N-trans-feruloyl Tyramine Bioactives on Fat Oxidation in Adult Women With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06548048
- Acronym / sponsor ID
- BIO-2406
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- BrightseedIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Aug 2024 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Treatment | Placebo comparator | Dietary Supplement: Microcrystaline cellulose |
| Active high dose of plant derived phenolics | Active comparator | Dietary Supplement: Dietary supplement containing plant derived phenolics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female, ≥18 and <50 years of age at visit 1 (day -28).
- Body mass index (BMI) of ≥29.0 kg/m2 to <40.0 kg/m2 at visit 1 (day -28).
- No health conditions that would prevent fulfilling the study requirements as judged by the Investigator on the basis of medical history.
- History of regular menstrual cycles with menses (21-35 d per cycle) for at least 3 months prior to visit 1 (day -28).
- Stable use of non-weight loss (e.g., semaglutide) prescription medications allowed, where stable use is defined as the same class of medication and dose for at least 90 d prior to visit 1 (day -28).
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Dietary supplement containing plant derived phenolicsDietary supplement containing plant derived phenolics | Dietary supplement | Active high dose of plant derived phenolics |
| Microcrystaline celluloseMicrocrystaline cellulose (MCC) | Dietary supplement | Placebo Treatment |
Primary outcome
% deuterium (2H) label from oxidation of d31-palmitic acid
Time frame: 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)
Percentage recovery of the deuterium (2H) label from oxidation of d31-palmitic acid to water in urine samples collected
7 secondary outcomes
Change in indirect calorimetry measures
Time frame: day 1 and day 28
Change in indirect calorimetry measures
Time frame: day 1 and day 28
Change in cardiometabolic parameters
Time frame: day 1 and day 28
Change in cardiometabolic parameters
Time frame: day 1 and day 28
Change in cardiometabolic parameters
Time frame: day 1 and day 28
Change in cardiometabolic parameters
Time frame: day 1 and day 28
Change in body weight
Time frame: day 1 and day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement containing plant derived phenolics and Microcrystaline cellulose in people with Overweight and Obesity, run by Brightseed 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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% deuterium (2H) label from oxidation of d31-palmitic acid (time frame: 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)). 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 12 Aug 2024.