Cardiometabolic SyndromeNCT06313580
Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile
A study testing Yogurt with added Spices and Yogurt without added Spices in people with Cardiometabolic Syndrome, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- Yogurt with added Spices and Yogurt without added Spices
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2
Who cannot join
- Dx - Diagnosis of cardiovascular disease, type 1 or 2 diabetes, liver disease, cancer, endocrine disorders, or inflammatory condition such as rheumatoid arthritis.
- GI - History of gastrointestinal surgery, irritable bowel syndrome, intestinal bowel disease, or other gastrointestinal distress such as chronic diarrhea, bulimia, anorexia, or frequent laxative use
- Rx or Supplements - Actively taking steroids or antibiotics in the previous two to three months, or currently using tobacco products, > 10% weight loss or gain in the last 6 months, unwilling to stop taking prebiotic/probiotic or fiber supplements
- Dietary - Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama
Tuscaloosa, Alabama, 35487
Kristi M. Crowe-White, PhD, RD, 205-348-6173, kcrowe@ches.ua.edu
About this study
Official title: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study
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.
Read the detailed description
Study will be conducted as a single blind, randomized crossover design with a 4-week arm (placebo or control) followed by a 2-week washout period and another 4-week arm (placebo or control).
- Conditions
- Cardiometabolic Syndrome
- Being tested
- Yogurt with added Spices, Yogurt without added Spices
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt with added SpicesOther
Consumption of twice daily yogurt with added spices for four weeks.
Yogurt without added SpicesOther
Consumption of twice daily yogurt without added spices for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Yogurt with added Spices | Experimental | Consumption of twice daily yogurt with added spices for four weeks. Receives: Other: Yogurt with added Spices |
| Sham Arm - Yogurt without added Spices | Sham comparator | Consumption of twice daily yogurt without added spices for four weeks. Receives: Other: Yogurt without added Spices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
Units - uM
Measured: pre/post each four-week study arm
Concentration of serum leptin
Units - ng/mL
Measured: pre/post each four-week study arm
Concentration of serum ghrelin (pg/mL)
Units - pg/mL
Measured: pre/post each four-week study arm
Concentration of serum peptide tyrosine tyrosine (PYY)
Units - pg/mL
Measured: pre/post each four-week study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313580
- Sponsor's protocol ID
- 22-1055
- Status last verified
- Mar 2024
- First submitted
- 3 Jan 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study
- ClinicalTrials.gov ID
- NCT06313580
- Acronym / sponsor ID
- 22-1055
- Conditions
- Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study will be conducted as a single blind, randomized crossover design with a 4-week arm (placebo or control) followed by a 2-week washout period and another 4-week arm (placebo or control).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Yogurt with added Spices | Experimental | Other: Yogurt with added SpicesConsumption of twice daily yogurt with added spices for four weeks. |
| Sham Arm - Yogurt without added Spices | Sham comparator | Other: Yogurt without added SpicesConsumption of twice daily yogurt without added spices for four weeks. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2
Key exclusion criteria (4 listed)
- Dx - Diagnosis of cardiovascular disease, type 1 or 2 diabetes, liver disease, cancer, endocrine disorders, or inflammatory condition such as rheumatoid arthritis.
- GI - History of gastrointestinal surgery, irritable bowel syndrome, intestinal bowel disease, or other gastrointestinal distress such as chronic diarrhea, bulimia, anorexia, or frequent laxative use
- Rx or Supplements - Actively taking steroids or antibiotics in the previous two to three months, or currently using tobacco products, > 10% weight loss or gain in the last 6 months, unwilling to stop taking prebiotic/probiotic or fiber supplements
- Dietary - Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt with added SpicesConsumption of twice daily yogurt with added spices for four weeks. | Other | Intervention Arm - Yogurt with added Spices |
| Yogurt without added SpicesConsumption of twice daily yogurt without added spices for four weeks. | Other | Sham Arm - Yogurt without added Spices |
Primary outcome
Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
Time frame: pre/post each four-week study arm
Units - uM
Concentration of serum leptin
Time frame: pre/post each four-week study arm
Units - ng/mL
Concentration of serum ghrelin (pg/mL)
Time frame: pre/post each four-week study arm
Units - pg/mL
Concentration of serum peptide tyrosine tyrosine (PYY)
Time frame: pre/post each four-week study arm
Units - pg/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt with added Spices and Yogurt without added Spices in people with Cardiometabolic Syndrome, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristi M Crowe-White, PhD, RD (205-348-6173, kcrowe@ches.ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate (time frame: pre/post each four-week study arm). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.