Over Age 60CUR-T2DNCT06984640
Curcumin Supplementation for the Improvement of Diabetes-related Outcomes
A study testing Curcumin in people with Over Age 60 and Prediabetes or Overweight, run by Oklahoma State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about, test, and compare health outcomes of curcumin supplementation (400 mg). Two primary hypotheses are: 1. Curcumin supplementation will improve glycemic control in older adults with pre-diabetic conditions over a 12-week period. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Over Age 60, Prediabetes or Overweight
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2023to 13 Feb 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible, participants were required to meet at least one of the following criteria: a) Prediabetes, defined as a fasting blood glucose level of 100-125 mg/dL or an HbA1c of 5.7-6.4%, or b) A body mass index (BMI) ≥25.
Who cannot join
- a) A preexisting cardiometabolic condition such as diabetes, b) Liver disease, c) De-mentia, d) Tobacco use within one year prior to the study, and e) Use of medications targeting diabetes or blood lipids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for Applied Nutrition and Exercise Science (LANES)
Stillwater, Oklahoma, 74078
About this study
The goal of this clinical trial is to learn about, test, and compare health outcomes of curcumin supplementation (400 mg). Two primary hypotheses are:
- Curcumin supplementation will improve glycemic control in older adults with pre-diabetic conditions over a 12-week period.
Read more
- Rationale: Curcumin has been shown to enhance insulin sensitivity, reduce fasting blood glucose, and lower HbA1c levels in preclinical and clinical studies. This hypothesis will be tested by measuring changes in fasting glucose, insulin levels, and diabetic biomarkers from baseline (Week 0) to Week 12.
- Curcumin supplementation will beneficially alter gut microbiota composition and diversity, which is associated with improved metabolic outcomes in older adults with pre-diabetes.
- Rationale: Curcumin is known to possess prebiotic-like properties and can influence gut microbial populations. By analyzing stool samples using metagenomic sequencing, this hypothesis will evaluate whether curcumin intake leads to increased abundance of beneficial bacteria (e.g., Akkermansia, Faecalibacterium) and decreased pathogenic taxa, alongside improved metabolic markers.
- Conditions
- Over Age 60, Prediabetes or Overweight
- Being tested
- Curcumin, Placebo
- Keywords
- Curcumin, Aging
- Medical subject headings
- Prediabetic State, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. Longvida® is a trademark of Vendure Sciences, Noblesville, IN, USA.
PlaceboDietary supplement
Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Group | Experimental | Eligible participants were randomly assigned to receive a curcumin capsule daily for 12 weeks. Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. Longvida® is a trademark of Vendure Sciences, Noblesville, IN, USA. Treatment capsules were dispensed in bottles after baseline measurements were completed, with instructions to take one capsule per day after a meal. Receives: Dietary Supplement: Curcumin |
| Placebo Group | Placebo comparator | Eligible participants were randomly assigned to receive a placebo capsule daily for 12 weeks. Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of dextrin with 0.05% tartrazine (a yellow food coloring). Treatment capsules were dispensed in bottles after baseline measurements were completed, with instructions to take one capsule per day after a meal. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Using a standard scale, body weight in kg was assessed
Measured: 1 year
Body Composition
Using Dual-energy X-ray absorptiometry(DXA), body composition was assessed
Measured: 1 year
Fat Mass Percentage
Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage was assessed
Measured: 1 year
Fat-Free Mass Percentage
Using Dual-energy X-ray absorptiometry(DXA), fat-free mass was assessed
Measured: 1 year
Secondary outcomes (7)
Triglyceride Levels
Blood draw followed by a Piccolo scan analyzed Triglyceride levels in the blood
Measured: 1 year
Glucose Levels
Blood draw followed by a Piccolo scan analyzed glucose in the blood
Measured: 1 year
HDL
Blood draw followed by a Piccolo scan analyzed HDL in the blood
Measured: 1 year
LDL
Piccolo scan analyzed LDL in the blood
Measured: 1 year
HbA1c
Piccolo scan analyzed HbA1c in the blood
Measured: 1 year
Alanine transaminase (ALT)
Blood draw followed by a Piccolo scan analyzed ALT in the blood
Measured: 1 year
Aspartate transaminase (AST)
Blood draw followed by a Piccolo scan analyzed AST in the blood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start16 Mar 2023
- Primary completion14 Feb 2024
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over Age 60Studies 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
- Single group
- Model description
- * Age: Over 60 years (male and female)-preference is with pre-diabetic condition * Participants: around 20-25 per group (placebo and treatment) \<Screening method\> * Recruiting * Initial visit: questionnaire and fasting glucose test * Selecting participants: 20-25 placebo group / 20-25 curcumin supplement group * Criteria for selection * A1C level: 5.7-6.4% or * Fasting blood glucose level: 100-125 mg/dL * BMI ≥ 26-30 (≥ 30 will be considered if numbers are not enough) \* Exclusion criteria * A preexisting cardiometabolic condition such as diabetes * Liver disease * Dementia * Tobacco use within one year prior to the study * Use of medications targeting diabetes or blood lipids
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984640
- Sponsor's protocol ID
- IRB-23-7-STW
- Other IDs
- 1-503351
- Acronym
- CUR-T2D
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Supplementation for the Improvement of Diabetes-related Outcomes
- ClinicalTrials.gov ID
- NCT06984640
- Acronym / sponsor ID
- CUR-T2D / IRB-23-7-STW
- Conditions
- Over Age 60, Prediabetes or Overweight
- Keywords
- Curcumin, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 22 May 2025 (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.
The goal of this clinical trial is to learn about, test, and compare health outcomes of curcumin supplementation (400 mg). Two primary hypotheses are:
- Curcumin supplementation will improve glycemic control in older adults with pre-diabetic conditions over a 12-week period.
- Rationale: Curcumin has been shown to enhance insulin sensitivity, reduce fasting blood glucose, and lower HbA1c levels in preclinical and clinical studies. This hypothesis will be tested by measuring changes in fasting glucose, insulin levels, and diabetic biomarkers from baseline (Week 0) to Week 12.
- Curcumin supplementation will beneficially alter gut microbiota composition and diversity, which is associated with improved metabolic outcomes in older adults with pre-diabetes.
- Rationale: Curcumin is known to possess prebiotic-like properties and can influence gut microbial populations. By analyzing stool samples using metagenomic sequencing, this hypothesis will evaluate whether curcumin intake leads to increased abundance of beneficial bacteria (e.g., Akkermansia, Faecalibacterium) and decreased pathogenic taxa, alongside improved metabolic markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- * Age: Over 60 years (male and female)-preference is with pre-diabetic condition * Participants: around 20-25 per group (placebo and treatment) <Screening method> * Recruiting * Initial visit: questionnaire and fasting glucose test * Selecting participants: 20-25 placebo group / 20-25 curcumin supplement group * Criteria for selection * A1C level: 5.7-6.4% or * Fasting blood glucose level: 100-125 mg/dL * BMI ≥ 26-30 (≥ 30 will be considered if numbers are not enough) * Exclusion criteria * A preexisting cardiometabolic condition such as diabetes * Liver disease * Dementia * Tobacco use within one year prior to the study * Use of medications targeting diabetes or blood lipids
| Arm | Type | Receives |
|---|---|---|
| Curcumin Group | Experimental | Dietary Supplement: CurcuminEligible participants were randomly assigned to receive a curcumin capsule daily for 12 weeks. Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. Longvida® is a trademark of Vendure Sciences, Noblesville, IN, USA. Treatment capsules were dispensed in bottles after baseline measurements were completed, with instructions to take one capsule per day after a meal. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboEligible participants were randomly assigned to receive a placebo capsule daily for 12 weeks. Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of dextrin with 0.05% tartrazine (a yellow food coloring). Treatment capsules were dispensed in bottles after baseline measurements were completed, with instructions to take one capsule per day after a meal. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible, participants were required to meet at least one of the following criteria: a) Prediabetes, defined as a fasting blood glucose level of 100-125 mg/dL or an HbA1c of 5.7-6.4%, or b) A body mass index (BMI) ≥25.
Key exclusion criteria (1 listed)
- a) A preexisting cardiometabolic condition such as diabetes, b) Liver disease, c) De-mentia, d) Tobacco use within one year prior to the study, and e) Use of medications targeting diabetes or blood lipids.
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 |
|---|---|---|
| CurcuminEach capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. Longvida® is a trademark of Vendure Sciences, Noblesville, IN, USA. | Dietary supplement | Curcumin Group |
| PlaceboEach capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. | Dietary supplement | Placebo Group |
Primary outcome
Body Weight
Time frame: 1 year
Using a standard scale, body weight in kg was assessed
Body Composition
Time frame: 1 year
Using Dual-energy X-ray absorptiometry(DXA), body composition was assessed
Fat Mass Percentage
Time frame: 1 year
Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage was assessed
Fat-Free Mass Percentage
Time frame: 1 year
Using Dual-energy X-ray absorptiometry(DXA), fat-free mass was assessed
7 secondary outcomes
Triglyceride Levels
Time frame: 1 year
Glucose Levels
Time frame: 1 year
HDL
Time frame: 1 year
LDL
Time frame: 1 year
HbA1c
Time frame: 1 year
Alanine transaminase (ALT)
Time frame: 1 year
Aspartate transaminase (AST)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Over Age 60 and Prediabetes or Overweight, run by Oklahoma State University 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 1 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: finished, as of the sponsor's last update on 22 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 1 year). 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 22 May 2025.