Pulses for Obesity

(PS Trial)

Overseen By Indika Edirisinghe, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

Must not be taking: Antioxidants, Anti-inflammatories, Lipid-lowering, Blood pressure-lowering

Disqualifiers: Smoking, Cancer, Vascular disease, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

103 Participants Needed

Trial Summary

What is the purpose of this trial?

Objective 1: Characterize indices of systemic inflammation and gut microbiota composition and function after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants. Objective 2: Characterize dietary- and microbial-derived metabolite pools after regular intake of pulses (12 weeks) in human participants with OW/OB-IR compared to control diet. Objective 3: Characterize cognitive functioning after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications or supplements that could interfere with the study, such as lipid-lowering medications, anti-inflammatory drugs, and dietary supplements. If you are taking dietary supplements, a 30-day period without them is required before starting the trial.

What data supports the effectiveness of the treatment Pulses for Obesity?

Research shows that consuming beans, like navy beans, can help reduce waist size, which is a key factor in managing obesity. Additionally, a study on a natural weight-reduction agent that reduces sugar absorption showed significant weight loss, suggesting that similar natural treatments could be effective for obesity. ^{1 2 3 4 5}

Is the consumption of pulses like beans safe for humans?

Research on various types of beans, such as navy beans and pinto beans, suggests they are generally safe for human consumption and may even offer health benefits like reducing waist circumference and improving heart health markers. ^{1 4 5 6 7}

How is the Pulses for Obesity treatment different from other obesity treatments?

The Pulses for Obesity treatment is unique because it uses black beans and chickpeas, which are pulses known for their high fiber and protein content, to help manage weight by increasing satiety (feeling of fullness) and reducing fat accumulation. Unlike many other treatments that focus on reducing the consequences of obesity, this approach aims to prevent weight gain by incorporating these nutrient-rich foods into the diet. ^{1 6 8 9 10}

Research Team

Indika Edirisinghe, Ph.D

Principal Investigator

Illinois Insititute of Technology

Eligibility Criteria

This trial is for men and women over 18 with a BMI ≥ 25, fasting blood glucose between 100-125 mg/dL, non-smokers or those who quit over two years ago. Participants should be in good health without major diseases or taking medications that affect the study outcomes. They must not drink alcohol or engage in vigorous exercise before visits.

Inclusion Criteria

Men or women, age 18 or older

BMI ≥ 25 kg/m2

Fasting blood glucose concentration between 100 mg/dL and 125 mg/dL at the screening visit

Exclusion Criteria

You have taken antibiotics in the last 2 months.

Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results

Women who are known to be pregnant or who are intending to become pregnant over the course of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Diet Stabilization and Wash-in

Participants undergo a 1-week diet stabilization and wash-in from anthocyanins and ellagitannins before randomization

1 week

Treatment

Participants receive one of three dietary interventions (control, black bean, or chickpea) for 12 weeks, with biweekly food pick-up and compliance visits

12 weeks

4 biweekly food pick-up/compliance visits, 3 Test Day Visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive testing and collection of biological samples

4 weeks

Treatment Details

Interventions

• Black bean
• Chickpea
• Control

Trial Overview The trial examines how eating pulses (black beans and chickpeas) versus a control diet for 12 weeks affects systemic inflammation, insulin sensitivity, gut microbiome composition, metabolite pools, and cognitive function in overweight/obese individuals with insulin resistance.

Participant Groups

Group I: Black bean Active Control 1 Intervention

A cup of black bean 7 days/week over a 12-week period

Group II: Chickpea Active Control 1 Intervention

A cup of chickpea 7 days/week over a 12-week period

Group III: Control Placebo Group 1 Intervention

A cup of white rice 7 days/week over a 12-week period

Who Is Running the Clinical Trial?

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead Sponsor

Trials

55

Recruited

3,000+

USDA Beltsville Human Nutrition Research Center

Collaborator

Trials

56

Recruited

5,300+

Findings from Research

In a study of 60 healthy overweight subjects, those who took Beanblock® for 12 weeks experienced significant weight loss (from 82.8 kg to 78.8 kg) and a reduction in waist circumference (from 94.4 cm to 88.2 cm), while the control group showed only minor changes.

Beanblock® also significantly reduced oxidative stress levels and improved feelings of satiety and appetite, with no reported side effects, indicating it is a safe and effective supplement for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beanblock® (standardized dry extract of Phaseolus vulgaris) in mildly overweight subjects: a pilot study. Luzzi, R., Belcaro, G., Hu, S., et al.[2018]

Obesity has more than doubled in the U.S. over the past 30 years, leading to increased risks for serious health issues like type 2 diabetes and certain cancers, highlighting the urgent need for effective treatment and prevention strategies.

Current treatment options for obesity include lifestyle changes, FDA-approved medications like sibutramine and orlistat, and bariatric surgery, but the review emphasizes the importance of evaluating the safety and efficacy of various weight-loss diets and over-the-counter supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective on the current strategies for the treatment of obesity. Joyal, SV.[2019]

In a study of 14 overweight and obese adults, consuming 5 cups of canned navy beans per week for 4 weeks significantly reduced waist circumference, with females losing an average of 2.5 cm and males 2.1 cm (P < 0.001).

The consumption of navy beans also positively affected metabolic risk factors, showing a notable decrease in pulse rate, total cholesterol, and LDL cholesterol in males, while females experienced an increase in pulse rate but stable cholesterol levels, indicating a sex-dependent response to bean consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canned Navy Bean Consumption Reduces Metabolic Risk Factors Associated with Obesity. Luhovyy, BL., Mollard, RC., Panahi, S., et al.[2017]

A systematic review of 21 clinical trials showed that pulse crop consumption, particularly common beans, is linked to better weight control and reduced body fat, although the exact mechanisms were unclear.

In a study using rat models, bean consumption reduced visceral fat and adipocyte size without affecting food efficiency, and it enhanced fatty acid oxidation in the liver, suggesting that beans may help combat obesity through improved lipid metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Common Bean on Adiposity and Lipid Metabolism. Thompson, HJ., McGinley, JN., Neil, ES., et al.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Beanblock® (standardized dry extract of Phaseolus vulgaris) in mildly overweight subjects: a pilot study. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A perspective on the current strategies for the treatment of obesity. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled trial of a new weight-reducing agent of natural origin. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Pinto bean consumption reduces biomarkers for heart disease risk. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Canned Navy Bean Consumption Reduces Metabolic Risk Factors Associated with Obesity. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Consumption of Common Bean Suppresses the Obesogenic Increase in Adipose Depot Mass: Impact of Dose and Biological Sex. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Edible dry bean consumption (Phaseolus vulgaris L.) modulates cardiovascular risk factors and diet-induced obesity in rats and mice. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Pulse consumption, satiety, and weight management. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Common Bean on Adiposity and Lipid Metabolism. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Common Bean Baked Snack Consumption Reduces Apolipoprotein B-100 Levels: A Randomized Crossover Trial. [2021]