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

Trial Summary

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.

What data supports the effectiveness of the treatment 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 other risk factors for metabolic disorders. Additionally, curcumin, a polyphenol in turmeric, has been shown to have beneficial effects on metabolic diseases, suggesting that spiced yogurt could offer similar benefits. ^{1 2 3 4 5}

Is spiced yogurt safe for human consumption?

Research on yogurts with added spices or polyphenols, like hot pepper juice or olive polyphenols, suggests they are generally safe for human consumption. These studies did not report any significant adverse effects, indicating that spiced yogurts can be consumed safely. ^{1 5 6 7 8}

How is the Spiced Yogurt treatment different from other treatments for metabolic health?

Spiced Yogurt is unique because it combines yogurt with polyphenol-rich spices, which may enhance its antioxidant and anti-obesity effects. This approach leverages the natural properties of spices to potentially improve metabolic health, unlike conventional treatments that may not use such natural ingredients. ^{1 2 5 8 9}

What is the purpose of this trial?

Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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]

References

1. Switzerland 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. [2018]

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

Effect of Yogurt Consumption on Metabolic Syndrome Risk Factors: a Narrative Review. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Two untargeted metabolomics reveals yogurt-associated metabolic alterations in women with multiple metabolic disorders from a randomized controlled study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Curcumin in Metabolic Health and Disease. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Biochemical, Microbiological, and Sensory Characteristics of Stirred Yogurt Containing Red or Green Pepper (Capsicum annuum cv. Chungyang) Juice. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Fortification of yogurts with different antioxidant preservatives: A comparative study between natural and synthetic additives. [2018]

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

Yogurt - A Compositional Survey in the Greater Lansing Area 1. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effect of functional yogurt NY-YP901 in improving the trait of metabolic syndrome. [2017]

9. Switzerland 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. [2020]