Weight LossNCT01452841
A Grapefruit Feeding Trial in Healthy, Overweight Adults
A study testing Grapefruit in people with Weight Loss and Obesity, run by University of Arizona at 1 site in United States.
Trial summary
Folklore has suggested that consuming grapefruit may promote weight control. Sparse data exist to support this hypothesis, though there is some evidence of health promotional effects regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are to determine the role of grapefruit in: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Cardiovascular Risk Factors
- What is being tested?
- Grapefruit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, men and premenopausal women
- BMI: 25-45 kg/m2
- Willing to maintain current exercise regimen (not to exceed 10 hours/week)
- Willing to follow a diet low in bioactive rich fruits and vegetables and with no citrus
Who cannot join
- History of chronic disease
- Metabolic disease
- Inflammatory disease
- High cholesterol (>225 mg/dL)
- Smoker
- Taking medications metabolized by the Cytochrome P450 3A enzyme
- History of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Daily Grapefruit Exposure in Reducing Body Weight and Inflammatory Markers
Folklore has suggested that consuming grapefruit may promote weight control. Sparse data exist to support this hypothesis, though there is some evidence of health promotional effects regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are to determine the role of grapefruit in:
- Reducing weight
- Reducing blood pressure
- Reducing inflammation
- Improving the lipid profile.
The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce weight, blood pressure, and inflammation while improving the lipid profile in overweight, healthy adults.
- Conditions
- Weight Loss, Obesity, Cardiovascular Risk Factors
- Being tested
- Grapefruit, Control
- Keywords
- grapefruit, weight loss, blood pressure, lipids, inflammation
- Medical subject headings
- Weight Loss, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrapefruitOther
1.5 Rio Red Grapefruit consumed daily for 6 weeks
ControlOther
Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Grapefruit Consumption | Experimental | Not described Receives: Other: Grapefruit |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
Participants consumed 1/2 grapefruit before each meal (1.5 grapefruit per day) for six weeks. Weight was measured before and after grapefruit consumption to assess weight change. Weight change was considered statistically significant at p<0.05.
Measured: 6 weeks
Secondary outcomes (3)
Blood pressure reduction
Previous studies in animals and humans consuming citrus have resulted in reductions in blood pressure, though no direct effect of grapefruit has ever been demonstrated. Blood pressure was measured at baseline and after the 6 week intervention period (consuming either the control diet or supplementing the diet with 1/2 grapefruit before each meal).
Measured: 6 weeks
Lipid Profile Improvements
Previous studies in humans and animal models consuming grapefruit or grapefruit bioactives have shown reductions in triglycerides, LDL, and total cholesterol and increases in circulating HDL. These parameters were measured via a common point-of-care system, LDX Cholestech. Lipids were measured at baseline and after the 6 week intervention period (consuming either the control diet or supplementing the diet with 1/2 grapefruit before each meal).
Measured: 6 weeks
Reductions in markers of chronic inflammation
Markers of chronic inflammation, which are also associated with endothelial dysfunction and heart disease, like tumor necrosis factor alpha (TNFalpha), interleukin-1beta (IL-1beta), and soluble vascular cellular adhesion molecule-1 (sV-CAM1) were measured. Inflammatory markers were measured at baseline and after the 6 week intervention period (consuming either the control diet or supplementing the diet with 1/2 grapefruit before each meal).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startAug 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Cynthia Thomson, PhD, RD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452841
- Sponsor's protocol ID
- 09-0695-02
- Status last verified
- Oct 2011
- First submitted
- 21 Jul 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Daily Grapefruit Exposure in Reducing Body Weight and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT01452841
- Acronym / sponsor ID
- 09-0695-02
- Conditions
- Weight Loss, Obesity, Cardiovascular Risk Factors
- Keywords
- grapefruit, weight loss, blood pressure, lipids, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Texas A&M University
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Oct 2011 (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.
Folklore has suggested that consuming grapefruit may promote weight control. Sparse data exist to support this hypothesis, though there is some evidence of health promotional effects regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are to determine the role of grapefruit in:
- Reducing weight
- Reducing blood pressure
- Reducing inflammation
- Improving the lipid profile.
The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce weight, blood pressure, and inflammation while improving the lipid profile in overweight, healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grapefruit Consumption | Experimental | Other: Grapefruit |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, men and premenopausal women
- BMI: 25-45 kg/m2
- Willing to maintain current exercise regimen (not to exceed 10 hours/week)
- Willing to follow a diet low in bioactive rich fruits and vegetables and with no citrus
Key exclusion criteria (7 listed)
- History of chronic disease
- Metabolic disease
- Inflammatory disease
- High cholesterol (>225 mg/dL)
- Smoker
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 |
|---|---|---|
| Grapefruit1.5 Rio Red Grapefruit consumed daily for 6 weeks | Other | Grapefruit Consumption |
| ControlParticipants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks | Other | Control |
Primary outcome
Weight reduction
Time frame: 6 weeks
Participants consumed 1/2 grapefruit before each meal (1.5 grapefruit per day) for six weeks. Weight was measured before and after grapefruit consumption to assess weight change. Weight change was considered statistically significant at p<0.05.
3 secondary outcomes
Blood pressure reduction
Time frame: 6 weeks
Lipid Profile Improvements
Time frame: 6 weeks
Reductions in markers of chronic inflammation
Time frame: 6 weeks
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 17 Oct 2011.
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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.
Cynthia Thomson, PhD, RD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grapefruit in people with Weight Loss and Obesity, run by University of Arizona 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 4 inclusion and 7 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 17 Oct 2011. 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?
Weight reduction (time frame: 6 weeks). 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 17 Oct 2011.