Premenopausal WomenPPTNCT02167607
A Pilot Study to Characterize the Bioavailability and Plasma Profile of Potato Polyphenols in Humans
A study testing Active Comparator in people with Premenopausal Women and Overweight and Obese Women, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period. Secondary objective is to assess the influence of potatoes' bioavailability and kinetic profiles on markers of chronic diseases. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenopausal Women, Overweight and Obese Women
- What is being tested?
- Active Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2014to 11 Nov 2014
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women with regular menstrual cycle
- Aged between 20 to 45 years old
- Body Mass Index (BMI) range from 25 to 35 kg/m2; exception BMI 23 to 35 kg/m2 for Asian population
- Fasting blood glucose concentration < 110 mg/dL
- Fasting hs-CRP >2 mg/dL to < 10 mg/dL
- Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months
Show all 11Show fewer
- Non-smokers
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications or dietary supplements that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol
Who cannot join
- Men
- Past smokers: abstinence for less than 2 years
- Women who smoke
- Women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
- Women known to have/diagnosed with diabetes mellitus
- Women who have fasting blood glucose concentrations ≥110 mg/dL
Show all 19Show fewer
- Women who have uncontrolled blood pressure >140 mmHg/90 mmHg
- Women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
- Women with cancer other than non-melanoma skin cancer in previous 5 years.
- Women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
- Women who are taking blood pressure lowering medication that may interfere the outcomes of the study; e.g. diuretics.
- Women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Women who are vegetarians or vegans
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (> 4 cups/day); berry and grape consumers (>2 cups/day)
- Women who do excessive exercise regularly or athlete
- Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period.
Secondary objective is to assess the influence of potatoes' bioavailability and kinetic profiles on markers of chronic diseases.
Read the detailed description
The proposed study is a single-center, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study that characterizes the bioavailability and kinetic profile of potatoes over 6-hour postprandial day (PPD).
A planned sample size of 12 will be enrolled into the study. This study will require one initial screening visit, pre-study visit, and 2 PPDs. This study will take 3-6 weeks per subject to complete.
The trial will initiate with a screening visit, which will last for about 1-1.5 hours where the subjects' height, weight, waist circumference, fasting blood glucose, fasting hs-CRP (high sensitivity C-reactive protein) concentration, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first PPD and for the duration of the study. Prior to each PPD, a dinner meal will be provided the day before the PPD to control the second meal effect from food and beverage intake of the night before the PPD.
Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each PPD will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. A standard high carbohydrate and high fat test meal with either 200g white potato or 200g purple potato will be served. Thereafter, timers will be started and blood sample will be collected at 20, 40, 60, 120, 180, 240, 300, and 360 minutes for assessment in plasma bioavailability and kinetic profile of potato polyphenols and changes in inflammation markers and relative metabolic indices. The sequence of receiving the potato treatment at each visit will be randomly assigned based on computer generated sequences: white potato-purple potato or purple potato-white potato.
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety and often resulting in increased intake. Both PPD visits will be placed at least 3 days apart as well.
- Conditions
- Premenopausal Women, Overweight and Obese Women
- Being tested
- Active Comparator, Placebo Comparator
- Keywords
- Purple Potatoes, Polyphenolics
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ComparatorDietary supplement
Also called Purple Potato
Purple Potato
Placebo ComparatorDietary supplement
Also called White Potato
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Purple Potato | Active comparator | Active Comparator Receives: Dietary Supplement: Active Comparator |
| White Potato | Placebo comparator | Placebo Comparator Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma polyphenol metabolite concentrations over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal.
To assess the kinetic profile and bioavailability of potato polyphenols when consume with a meal
Measured: 6 hours
Secondary outcomes (1)
Changes in metabolic and inflammation markers over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal.
The influence of white or purple potato consumption on metabolic and inflammation markers
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start1 Jun 2014
- Primary completion27 Oct 2014
- Study completion11 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenopausal WomenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, MS, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167607
- Sponsor's protocol ID
- 2014-033
- Acronym
- PPT
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2014
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Characterize the Bioavailability and Plasma Profile of Potato Polyphenols in Humans
- ClinicalTrials.gov ID
- NCT02167607
- Acronym / sponsor ID
- PPT / 2014-033
- Conditions
- Premenopausal Women, Overweight and Obese Women
- Keywords
- Purple Potatoes, Polyphenolics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 27 Oct 2014 (actual)
- Study completion
- 11 Nov 2014 (actual)
- First posted
- 19 Jun 2014 (estimated)
- 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.
Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period.
Secondary objective is to assess the influence of potatoes' bioavailability and kinetic profiles on markers of chronic diseases.
Detailed description
The proposed study is a single-center, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study that characterizes the bioavailability and kinetic profile of potatoes over 6-hour postprandial day (PPD).
A planned sample size of 12 will be enrolled into the study. This study will require one initial screening visit, pre-study visit, and 2 PPDs. This study will take 3-6 weeks per subject to complete.
The trial will initiate with a screening visit, which will last for about 1-1.5 hours where the subjects' height, weight, waist circumference, fasting blood glucose, fasting hs-CRP (high sensitivity C-reactive protein) concentration, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first PPD and for the duration of the study. Prior to each PPD, a dinner meal will be provided the day before the PPD to control the second meal effect from food and beverage intake of the night before the PPD.
Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each PPD will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. A standard high carbohydrate and high fat test meal with either 200g white potato or 200g purple potato will be served. Thereafter, timers will be started and blood sample will be collected at 20, 40, 60, 120, 180, 240, 300, and 360 minutes for assessment in plasma bioavailability and kinetic profile of potato polyphenols and changes in inflammation markers and relative metabolic indices. The sequence of receiving the potato treatment at each visit will be randomly assigned based on computer generated sequences: white potato-purple potato or purple potato-white potato.
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety and often resulting in increased intake. Both PPD visits will be placed at least 3 days apart as well.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purple Potato | Active comparator | Dietary Supplement: Active ComparatorActive Comparator |
| White Potato | Placebo comparator | Dietary Supplement: Placebo ComparatorPlacebo Comparator |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Premenopausal women with regular menstrual cycle
- Aged between 20 to 45 years old
- Body Mass Index (BMI) range from 25 to 35 kg/m2; exception BMI 23 to 35 kg/m2 for Asian population
- Fasting blood glucose concentration < 110 mg/dL
- Fasting hs-CRP >2 mg/dL to < 10 mg/dL
Key exclusion criteria (19 listed)
- Men
- Past smokers: abstinence for less than 2 years
- Women who smoke
- Women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
- Women known to have/diagnosed with diabetes mellitus
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 |
|---|---|---|
| Active ComparatorAlso: Purple PotatoPurple Potato | Dietary supplement | Purple Potato |
| Placebo ComparatorAlso: White PotatoPlacebo Comparator | Dietary supplement | White Potato |
Primary outcome
Changes in plasma polyphenol metabolite concentrations over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal.
Time frame: 6 hours
To assess the kinetic profile and bioavailability of potato polyphenols when consume with a meal
1 secondary outcome
Changes in metabolic and inflammation markers over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal.
Time frame: 6 hours
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 28 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Premenopausal Women
Recruiting
Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women
Hair Health
RecruitingObservational study
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
Breast Cancer
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Uterine Hemorrhage
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
Recruiting
The Influence of Plan B® on Cardiovascular Health.
Female, Premenopausal
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.
Britt Burton-Freeman, Ph.D, MS principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator in people with Premenopausal Women and Overweight and Obese Women, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 11 inclusion and 19 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 28 Jan 2021. 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?
Changes in plasma polyphenol metabolite concentrations over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal. (time frame: 6 hours). 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 28 Jan 2021.