Spiced Yogurt for Metabolic Health

Overseen By Kristi M Crowe-White, PhD, RD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Must not be taking: Steroids, Antibiotics

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spiced yogurt can improve gut health and overall metabolism. Researchers aim to determine if adding spices to yogurt can positively alter the gut microbiome and benefit heart health by producing helpful substances like short-chain fatty acids. Participants will consume either yogurt with added spices or plain yogurt twice a day for four weeks. Women who are post-menopausal, have a body mass index (BMI) between 18.5 and 34.9, and do not have certain medical conditions may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research on dietary impacts on health.

Will I have to stop taking my current medications?

The trial requires participants to stop taking prebiotic, probiotic, or fiber supplements. It does not specify if you need to stop other medications, but you should check with the trial organizers.

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

Research has shown that spiced yogurts are generally safe for consumption. Studies found that adding spices like hot pepper juice or olive extracts to yogurt does not cause major problems. Many people tolerate these ingredients well. Yogurt with added spices and probiotics can help prevent diseases and improve health without serious side effects. This suggests that yogurt with added spices is likely safe for clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about yogurt with added spices for metabolic health because it introduces a natural, dietary approach that could complement or even replace existing treatments like medications and lifestyle changes. Unlike conventional treatments that often focus on medication for managing metabolic conditions, this spiced yogurt leverages the potential health benefits of spices, which may help improve metabolism through natural means. This approach is appealing as it might offer a tasty and simple way to enhance metabolic health with minimal side effects, making it an attractive option for those looking for alternative or supplementary treatments.

What evidence suggests that this trial's treatments could be effective for metabolic health?

Research has shown that yogurt with added spices, a treatment in this trial, can improve metabolic health. These spices contain natural compounds called polyphenols, linked to reducing body weight and blood pressure and improving insulin levels. Studies have found that synbiotic yogurt, which combines probiotics and prebiotics, significantly lowers fasting blood sugar and insulin levels, crucial for managing diabetes. This type of yogurt can also reduce waist size relative to hip size and lower systolic blood pressure. These findings suggest that yogurt with added spices, as tested in this trial, might effectively support metabolic health. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Metabolic Syndrome or Cardiometabolic Syndrome. Specific eligibility criteria are not provided, but typically participants should be adults who meet the diagnostic criteria for these conditions and are able to consume yogurt.

Inclusion Criteria

I am a woman aged 50-69, post-menopausal, with a BMI between 18.5 and 34.9.

Exclusion Criteria

Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study

I have not used steroids, antibiotics, or tobacco, nor had significant weight changes recently. I am willing to stop taking prebiotic/probiotic or fiber supplements.

I have been diagnosed with a condition like heart disease, diabetes, liver disease, cancer, hormone disorders, or inflammation like rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume yogurt with or without added spices for four weeks in a crossover design

4 weeks

Twice daily consumption

Washout

A washout period to eliminate carryover effects between treatment arms

2 weeks

Treatment

Participants consume yogurt with or without added spices for another four weeks in a crossover design

4 weeks

Twice daily consumption

Follow-up

Participants are monitored for changes in gut microbiota and cardiometabolic profile

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yogurt with added Spices

Trial Overview The study is testing whether adding spices to yogurt can improve gut health and cardiometabolic profile by acting as a prebiotic. The effects on gut microbiota and related metabolic outcomes will be measured before and after consuming the spiced yogurt.

How Is the Trial Designed?

Group I: Intervention Arm - Yogurt with added Spices Experimental Treatment 1 Intervention

Consumption of twice daily yogurt with added spices for four weeks.

Group II: Sham Arm - Yogurt without added Spices Placebo Group 2 Interventions

Consumption of twice daily yogurt without added spices for four weeks.

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

McCormick Science Institute

Collaborator

Trials

12

Recruited

1,200+

McCormick Science Institute

Industry Sponsor

Trials

12

Recruited

1,200+

Published Research Related to This Trial

Fermented hot pepper juice, when added to yogurt, can enhance its nutritional profile by increasing total polyphenol content and antioxidant activity, which may contribute to anti-obesity effects.

Yogurt with 3% fermented red pepper juice or 1% green pepper juice was well-received in sensory tests for flavor and texture, indicating that the reduced pungency of the pepper juice makes it a palatable functional food option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical, Microbiological, and Sensory Characteristics of Stirred Yogurt Containing Red or Green Pepper (Capsicum annuum cv. Chungyang) Juice. Kang, SH., Yu, MS., Kim, JM., et al.[2020]

Natural antioxidant preservatives, specifically chamomile and fennel decoctions, can enhance the antioxidant activity of yogurts without altering their pH or nutritional value compared to control samples.

Using plant-based additives allows for the development of novel yogurts that replace synthetic preservatives while improving health benefits, particularly with chamomile showing the most significant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fortification of yogurts with different antioxidant preservatives: A comparative study between natural and synthetic additives. Caleja, C., Barros, L., Antonio, AL., et al.[2018]

A new type of yogurt enriched with volatile oils from basil, mint, lavender, and fennel was developed, showing significantly higher antioxidant activity compared to a control sample, which can help combat stress-related free radicals in the body.

The yogurt not only has antioxidant properties but also exhibits antimicrobial effects, suggesting it could enhance immunity and serve as a healthy dietary option during stressful times like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Yoghurt Enhanced with Volatile Plant Oils Encapsulated in Sodium Alginate to Increase the Human Body's Immunity in the Present Fight Against Stress. Tița, O., Constantinescu, MA., Tița, MA., et al.[2020]

In an 8-week study with 101 healthy participants, the functional yogurt NY-YP901 significantly reduced body weight, body mass index (BMI), and LDL-cholesterol levels compared to a placebo, indicating its potential benefits for metabolic syndrome.

Participants consuming NY-YP901 experienced a weight loss of -0.24 kg and a decrease in LDL-cholesterol by -7.71 mg/dl, suggesting that regular intake of this yogurt may help improve metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of functional yogurt NY-YP901 in improving the trait of metabolic syndrome. Chang, BJ., Park, SU., Jang, YS., et al.[2017]

A survey of 47 yogurt samples from six brands in mid-Michigan revealed significant variations in protein, fat, and total solids content, indicating a lack of consistency in yogurt composition.

About 25% of the yogurt samples were found to be overweight by more than 6.6%, and 10.6% weighed less than the declared net weight, suggesting a need for better quality control in commercial yogurt products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yogurt - A Compositional Survey in the Greater Lansing Area 1. Richmond, ML., Chandan, RC., Stine, CM.[2023]

Curcumin, a polyphenol from turmeric, has shown potential benefits in managing various metabolic disorders, including polycystic ovary syndrome and atherosclerosis, due to its antioxidant and anti-inflammatory properties.

Supplementing with curcumin may positively influence metabolic parameters, suggesting it could be a valuable dietary addition for treating metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin in Metabolic Health and Disease. Jabczyk, M., Nowak, J., Hudzik, B., et al.[2022]

In a 24-week randomized controlled trial involving 48 obese women with metabolic syndrome, yogurt consumption led to significant metabolic changes compared to milk, indicating its potential benefits for metabolic health.

Metabolomics analysis revealed that yogurt intervention altered pathways related to amino acid metabolism, fatty acid oxidation, cholesterol catabolism, and choline metabolism, suggesting mechanisms through which yogurt may help combat metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two untargeted metabolomics reveals yogurt-associated metabolic alterations in women with multiple metabolic disorders from a randomized controlled study. Du, S., Chen, Y., Liu, X., et al.[2022]

A review of 25 studies indicates that yogurt consumption, including various types like Greek and probiotic-enriched, has beneficial effects in preventing risk factors associated with metabolic syndrome (MetS), such as obesity and hypertension.

Yogurt's positive impact on MetS is linked to its components like calcium, vitamin D, proteins, and probiotics, suggesting that incorporating yogurt into a healthy diet may help reduce the risk of developing MetS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Yogurt Consumption on Metabolic Syndrome Risk Factors: a Narrative Review. Khorraminezhad, L., Rudkowska, I.[2021]

In a study involving 16 volunteers, consuming olive polyphenol-enriched yogurt for two weeks led to significant reductions in body weight, body mass index, hip circumference, and systolic blood pressure, indicating potential health benefits.

The polyphenol-enriched yogurt also enhanced the growth of beneficial lactic acid bacteria while potentially lowering LDL cholesterol levels and lipid peroxidation, suggesting it may improve gut health and metabolic parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of an Olive Fruit Polyphenol-Enriched Yogurt on Body Composition, Blood Redox Status, Physiological and Metabolic Parameters and Yogurt Microflora. Georgakouli, K., Mpesios, A., Kouretas, D., et al.[2018]

Citations

1. withpower.com withpower.com/trial/spiced-yogurt-for-metabolic-health-e7487

Spiced Yogurt for Metabolic Health Research shows that yogurt enriched with polyphenols, like those found in spices, can improve metabolic health by reducing body weight, blood pressure, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9952395/

Insights on Dietary Polyphenols as Agents against Metabolic ... Research demonstrates that dietary polyphenols can offer a novel path to developing functional foods for treating obesity.

3. researchgate.net researchgate.net/publication/387170095_The_effect_of_a_new_developed_synbiotic_yogurt_consumption_on_metabolic_syndrome_components_in_adults_with_metabolic_syndrome_a_randomized_controlled_clinical_trial

The effect of a new developed synbiotic yogurt ... Conclusions According to the findings of this study, daily consumption of the synbiotic yogurt was associated with improvements in insulin ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655839/

The effect of a new developed synbiotic yogurt consumption ... Synbiotic yogurt consumption significantly decreased fasting blood glucose, insulin, HOMA-IR, waist to hip ratio, and systolic blood pressure ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405457723011993

Functional yogurt, enriched and probiotic: A focus on ... In this study, the effect of fortified yogurt in preventing diseases and improving deficiencies has been investigated, and it has been proven that super healthy ...

6. researchgate.net researchgate.net/publication/373899098_Physicochemical_and_sensory_profile_of_spiced_yogurt_as_affected_by_ginger_supplementation

Physicochemical and sensory profile of spiced yogurt as ... Proximate data revealed that the moisture, carbohydrate, and protein content decreased as the SCE concentration increased while fat and ash content remained ...

7. mdpi.com mdpi.com/1422-0067/26/18/8813

Antioxidant Activity, Total Polyphenol Content, and Mineral ... In this study, higher antioxidant activity was observed in the tested beverages with a 10% addition of spice mixtures compared to their corresponding aqueous ...