Plant-Based Supplement for Body Fat

Overseen By Doug Bolster

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brightseed

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Gastrointestinal disorders, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a plant-based supplement can reduce body fat in generally healthy adults with a high body mass index (BMI) and conditions like high cholesterol or early signs of diabetes. Participants will receive either a low dose, high dose, or a placebo (a harmless pill with no active ingredient) to compare effects. Ideal participants have a BMI of 28-35, high cholesterol or early signs of diabetes, and do not use tobacco or nicotine. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new health solutions.

Do I need to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications as long as they are stable, meaning the same dose for at least 90 days before the trial starts. You should maintain a stable intake of your current medications throughout the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that natural compounds from plants, known as plant-derived phenolics, are generally safe for people. Studies have found that these compounds can help reduce body fat and improve health without causing serious side effects. For instance, one study reported a noticeable drop in body fat and cholesterol levels without any major negative effects. Another study found that polyphenols, which include phenolics, lowered inflammation and improved insulin handling, also with a good safety record. These results suggest that plant-derived phenolics are well-tolerated by humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these plant-derived phenolics treatments for reducing body fat because they offer a natural alternative to conventional options like prescription weight loss drugs or invasive procedures. Unlike most treatments that work by suppressing appetite or blocking fat absorption, these phenolics have unique antioxidant properties that may help target body fat directly. Additionally, being plant-based, they could potentially offer a safer profile with fewer side effects, making them particularly appealing for those looking for a more holistic approach to weight management.

What evidence suggests that this trial's treatments could be effective for reducing body fat?

Research has shown that natural compounds in plants, called phenolics, might help reduce body fat. Some studies found that these compounds can lead to weight loss. In one review, nine out of nineteen clinical trials reported an average weight loss of 1.5 kg over 12 weeks with these plant compounds. Phenolics may prevent the body from creating new fat cells and reduce inflammation and insulin resistance. In this trial, participants will receive either a low or high dose of plant-derived phenolics, or a placebo, to evaluate their effectiveness in managing body fat and related health risks. Overall, phenolics could offer a promising way to manage body fat and related health risks. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with a BMI of 28-35, dyslipidemia (cholesterol issues), or pre-diabetes are eligible for this trial. They must have stable medication use for the past 90 days and not be current tobacco or nicotine users. Participants should maintain their current diet and supplement intake throughout the study.

Inclusion Criteria

My LDL cholesterol is 130 mg/dL or higher.

My triglyceride levels are 150 mg/dL or higher.

My BMI is between 28.0 and less than 35.0.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dietary supplement containing plant-derived phenolics at two different dose levels or placebo

24 weeks

Visits at weeks 0, 4, 8, 12, 16, 20, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo treatment
• Plant derived phenolics

Trial Overview

The trial is testing how effective a dietary supplement with plant derived phenolics is at reducing body fat in adults at risk due to high BMI, dyslipidemia, or pre-diabetes. It compares two doses of the supplement against a placebo treatment.

How Is the Trial Designed?

Group I: Active low dose of plant derived phenolics Active Control 1 Intervention

Active low dose of plant derived phenolics via 1 capsule/day

Group II: Active high dose of plant derived phenolics Active Control 1 Intervention

Active high dose of plant derived phenolics via 1 capsule/day

Group III: Placebo treatment Placebo Group 1 Intervention

Placebo treatment (Microcrystaline cellulose): 1 capsule/day

Who Is Running the Clinical Trial?

Brightseed

Lead Sponsor

Trials

6

Recruited

560+

Published Research Related to This Trial

In a double-blind, placebo-controlled trial with 56 overweight subjects over two months, a daily supplement of 500 mg of polyphenolic extracts from Lippia citriodora and Hibiscus sabdariffa led to significant reductions in body weight and abdominal circumference compared to the placebo group.

The study suggests that the beneficial effects on fat metabolism may be linked to increased AMPK activity in fat cells, indicating a potential mechanism for how these plant polyphenols help combat obesity-related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of a combination of Hibiscus sabdariffa and Lippia citriodora polyphenols in overweight/obese subjects: A randomized controlled trial. Herranz-López, M., Olivares-Vicente, M., Boix-Castejón, M., et al.[2021]

A dietary supplement combining polyphenolic extracts from Lippia citriodora and Hibiscus sabdariffa was tested in a double-blind study with 54 overweight participants, showing improvements in body weight, blood pressure, and overall health perception over 60 days.

The supplement appeared to influence appetite regulation by increasing hormones that suppress hunger (like glucagon-like peptide-1) and decreasing those that stimulate it (like ghrelin), suggesting a potential mechanism for aiding weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hibiscus and lemon verbena polyphenols modulate appetite-related biomarkers in overweight subjects: a randomized controlled trial. [2018]

A proprietary blend of Lippia citriodora and Hibiscus sabdariffa, rich in polyphenols, was shown to significantly reduce body weight and fat mass in subjects over an 84-day period without requiring a controlled diet.

The most notable reduction in fat mass occurred in the trunk area, indicating that this supplement may specifically target abdominal fat, which is often linked to higher health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo Controlled Trial to Determine the Effectiveness a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) in the Reduction of Body Fat Mass in Healthy Subjects. Marhuenda, J., Perez, S., Victoria-Montesinos, D., et al.[2020]

Phenolic compounds found in popular plant-based products like cocoa, cinnamon, and olive oil have shown potential in managing obesity by reducing food intake, increasing fat breakdown, and inhibiting fat cell growth, based on various in vitro and in vivo studies.

The review highlights the anti-obesity effects of these compounds in nutraceuticals and functional foods, suggesting they may play a significant role in obesity management, although more research is needed to fully understand their mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phenolic compounds as natural and multifunctional anti-obesity agents: A review. Rodríguez-Pérez, C., Segura-Carretero, A., Del Mar Contreras, M.[2019]

This study will evaluate the effects of a (poly)phenol-rich supplement combined with a hypocaloric diet on weight and cardiometabolic health in 40 adults with morbid obesity over 12 weeks.

The research aims to uncover how (poly)phenols may influence energy metabolism, body composition, and gut microbiota diversity, potentially providing new strategies for managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a (poly)phenol-rich supplement on anthropometric, biochemical, and inflammatory parameters in participants with morbid obesity: Study protocol for a randomised controlled trial. Gil-Lespinard, M., Bambarén Capurro, C., Montserrat, M., et al.[2022]

Flavonoids can induce the browning of white adipose tissue (WAT) and activate brown adipose tissue (BAT), leading to increased energy expenditure and improved metabolic health, as shown through various studies up to March 2019.

The mechanism of action involves the activation of the sympathetic nervous system and the release of hormones like adrenaline, which enhance thermogenesis and fat metabolism through specific signaling pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavonoids as inducers of white adipose tissue browning and thermogenesis: signalling pathways and molecular triggers. Zhang, X., Li, X., Fang, H., et al.[2022]

Phenolic compounds found in many plants have been linked to various health benefits, including antioxidant and anti-inflammatory properties, and emerging evidence suggests they may also help combat obesity by inducing cell death in fat cells and preventing fat accumulation.

This review highlights the potential of phenolic compounds to influence obesity-related health issues, detailing their mechanisms of action at the molecular level, which could lead to new strategies for preventing obesity and its associated diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phenolic compounds: evidence for inhibitory effects against obesity and their underlying molecular signaling mechanisms. Hsu, CL., Yen, GC.[2022]

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