150 Participants Needed

Plant-Based Supplement for Body Fat

DB
Overseen ByDoug Bolster

Trial Summary

What is the purpose of this trial?

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

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.

What data supports the idea that Plant-Based Supplement for Body Fat is an effective treatment?

The available research shows that plant-based supplements containing polyphenols, like those from Hibiscus sabdariffa and Lippia citriodora, can help reduce body weight and abdominal circumference in overweight individuals. In one study, participants who took these supplements lost more inches around their waist compared to those who did not. Additionally, phenolic compounds found in plants have been shown to help manage obesity by reducing food intake and increasing the breakdown of fats. These findings suggest that plant-based supplements can be an effective treatment for reducing body fat.12345

What safety data exists for plant-based supplements for body fat reduction?

The safety data for plant-based supplements, specifically those containing polyphenols, is primarily derived from randomized controlled trials and reviews. These studies have evaluated the effects of polyphenolic extracts from plants like Hibiscus sabdariffa and Lippia citriodora in overweight and obese subjects. The trials were double-blind and placebo-controlled, indicating a rigorous approach to assessing safety and efficacy. While the focus is often on the efficacy of these supplements in reducing obesity-related parameters, the controlled nature of these studies suggests that safety is also monitored, although specific safety outcomes are not detailed in the abstracts provided.12345

Is the placebo treatment, Plant derived phenolics, a promising treatment for reducing body fat?

Yes, plant-derived phenolics, like those from Hibiscus and lemon verbena, have shown promise in reducing body fat and improving weight management. Studies have found that these natural compounds can help decrease body weight, reduce abdominal circumference, and lower fat mass, making them a promising treatment for managing obesity.12467

Eligibility Criteria

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: Active low dose of plant derived phenolicsActive Control1 Intervention
Active low dose of plant derived phenolics via 1 capsule/day
Group II: Active high dose of plant derived phenolicsActive Control1 Intervention
Active high dose of plant derived phenolics via 1 capsule/day
Group III: Placebo treatmentPlacebo Group1 Intervention
Placebo treatment (Microcrystaline cellulose): 1 capsule/day

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brightseed

Lead Sponsor

Trials
6
Recruited
560+

Findings from Research

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

References

Hibiscus and lemon verbena polyphenols modulate appetite-related biomarkers in overweight subjects: a randomized controlled trial. [2018]
Phenolic compounds as natural and multifunctional anti-obesity agents: A review. [2019]
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. [2022]
Differential effects of a combination of Hibiscus sabdariffa and Lippia citriodora polyphenols in overweight/obese subjects: A randomized controlled trial. [2021]
Phenolic compounds: evidence for inhibitory effects against obesity and their underlying molecular signaling mechanisms. [2022]
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. [2020]
Flavonoids as inducers of white adipose tissue browning and thermogenesis: signalling pathways and molecular triggers. [2022]
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