Fuel ManagementNCT01932879
Blackberry Polyphenol Intake and Fuel Management
A study testing Blackberry and Jello in people with Fuel Management, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation, and this may be the mechanism by which… Read more about this study
- Who is it for?
- Ages 25 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fuel Management
- What is being tested?
- Blackberry and Jello
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2016
- 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 25 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Younger than 25 years old or older than 75 years old
- Female
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)
- Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
Show all 18Show fewer
- Fasting triglycerides greater than 300 mg/dL
- Fasting glucose greater than 126 mg/dL
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
- Use of any tobacco products in past 3 months
- Use of oral or IV antibiotics during the month preceding the study
- Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- Known (self-reported) allergy or adverse reaction to blackberries
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation, and this may be the mechanism by which body fatness is influenced by anthocyanin intake. Well-controlled studies in humans are lacking.
- Conditions
- Fuel Management
- Being tested
- Blackberry, Jello
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlackberryOther
Participants will be fed a higher fat, typical American diet for two 1-week periods. Participants must consume only and all food provided during the intervention periods.
JelloOther
| Study group | Role | What they receive |
|---|---|---|
| Blackberry | Experimental | Participants will consume blackberries twice/day as part of a 1-week controlled diet. Receives: Other: Blackberry |
| Control | Other | Participants will consume jello twice/day as part of a 1-week controlled diet. Receives: Other: Jello |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substrate oxidation
Participants will stay in a room calorimeter for 23.5 hours.
Measured: 23.5 hours
Secondary outcomes (1)
Glucose tolerance test
Blood will be collected at the end of each diet period, at the following times before and after breakfast: -15, 0, 30, 60, 90, 120, 180, 240 minutes.
Measured: -15, 0, 30, 60, 90, 120, 180, 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuel ManagementStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932879
- Sponsor's protocol ID
- HS44
- Status last verified
- Dec 2016
- First submitted
- 27 Aug 2013
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blackberry Polyphenol Intake and Fuel Management
- ClinicalTrials.gov ID
- NCT01932879
- Acronym / sponsor ID
- HS44
- Conditions
- Fuel Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- Jul 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Aug 2013 (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.
Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation, and this may be the mechanism by which body fatness is influenced by anthocyanin intake. Well-controlled studies in humans are lacking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blackberry | Experimental | Other: BlackberryParticipants will consume blackberries twice/day as part of a 1-week controlled diet. |
| Control | Other | Other: JelloParticipants will consume jello twice/day as part of a 1-week controlled diet. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Younger than 25 years old or older than 75 years old
- Female
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)
- Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the 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 |
|---|---|---|
| BlackberryParticipants will be fed a higher fat, typical American diet for two 1-week periods. Participants must consume only and all food provided during the intervention periods. | Other | Blackberry |
| Jello | Other | Control |
Primary outcome
Substrate oxidation
Time frame: 23.5 hours
Participants will stay in a room calorimeter for 23.5 hours.
1 secondary outcome
Glucose tolerance test
Time frame: -15, 0, 30, 60, 90, 120, 180, 240 minutes
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 7 Dec 2016.
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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 Blackberry and Jello in people with Fuel Management, run by USDA Beltsville Human Nutrition Research Center 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 0 inclusion and 18 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 7 Dec 2016. 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. 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?
Substrate oxidation (time frame: 23.5 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 7 Dec 2016.