Healthy VolunteersNCT02769741
A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
A study of Healthy Volunteers, run by Kraft Heinz Company.
Trial summary
This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol. Read more about this study
- Who is it for?
- Ages 21 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 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 21 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of ≥18.00 and ≤32.00 kg/m^2
- Fasting LDL-C level ≥130 mg/dL and <200 mg/dL
- Fasting TG ≤350 mg/dL
Who cannot join
- CHD or CHD risk equivalent
- Pregnancy
- Use of lipid altering medications which cannot be stopped
- Certain liver, kidney, lung, or gastrointestinal conditions
- Poorly controlled hypertension
- Certain medications
Show all 9Show fewer
- Allergy or sensitivity to nuts or other food/beverage or food/beverage component
- Active cancers treated within prior 2 years (except non-melanoma skin cancer)
- Significant weight loss or gain within prior 3 months
About this study
Official title: A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol.
Read the detailed description
This trial will utilize a randomized, two-period crossover design to examine the effects of cashew consumption on LDL-C and other aspects of the fasting lipoprotein lipid profile in healthy, moderately hyper-cholesterolemic individuals consuming a typical "American diet." Two arms consisting of two 28-day controlled-feeding treatment periods will allow for an isocaloric comparison of a diet with or without cashews.
- Conditions
- Healthy Volunteers
- Being tested
- Cashews followed by Control, Control followed by Cashews
- Keywords
- Cashew, Lipoprotein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cashews followed by ControlOther
Participants will receive the active diet with cashew nuts as a daily snack during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the control diet at the same calorie level, but with a control snack instead of cashew nuts during Test Period II.
Control followed by CashewsOther
Participants will receive a controlled diet without cashew nuts during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the active diet at the same calorie level, but with cashew nuts as a daily snack during Test Period II.
| Study group | Role | What they receive |
|---|---|---|
| Crossover 1: Control Diet followed by Active Diet | Other | Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts Receives: Other: Control followed by Cashews |
| Crossover 2: Active Diet followed by Control Diet | Other | Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts Receives: Other: Cashews followed by Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C concentration measured in blood
Measured: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Secondary outcomes (5)
Total cholesterol change
Measured: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
HDL-cholesterol change
Measured: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Non-HDL-cholesterol change
Measured: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Triglyceride change
Measured: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Total cholesterol/HDL-cholesterol ratio change
Measured: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kraft Heinz Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Andrea Lawless, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769741
- Sponsor's protocol ID
- BIO-1509
- Status last verified
- Oct 2016
- First submitted
- 6 May 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mah E, Schulz JA, Kaden VN, Lawless AL, Rotor J, Mantilla LB, Liska DJ. Cashew consumption reduces total and LDL cholesterol: a randomized, crossover, controlled-feeding trial. Am J Clin Nutr. 2017 May;105(5):1070-1078. doi: 10.3945/ajcn.116.150037. Epub 2017 Mar 29.
PubMed 28356271
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
- ClinicalTrials.gov ID
- NCT02769741
- Acronym / sponsor ID
- BIO-1509
- Conditions
- Healthy Volunteers
- Keywords
- Cashew, Lipoprotein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kraft Heinz CompanyIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 May 2016 (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.
This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol.
Detailed description
This trial will utilize a randomized, two-period crossover design to examine the effects of cashew consumption on LDL-C and other aspects of the fasting lipoprotein lipid profile in healthy, moderately hyper-cholesterolemic individuals consuming a typical "American diet." Two arms consisting of two 28-day controlled-feeding treatment periods will allow for an isocaloric comparison of a diet with or without cashews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover 1: Control Diet followed by Active Diet | Other | Other: Control followed by CashewsTreatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts |
| Crossover 2: Active Diet followed by Control Diet | Other | Other: Cashews followed by ControlTreatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI of ≥18.00 and ≤32.00 kg/m^2
- Fasting LDL-C level ≥130 mg/dL and <200 mg/dL
- Fasting TG ≤350 mg/dL
Key exclusion criteria (9 listed)
- CHD or CHD risk equivalent
- Pregnancy
- Use of lipid altering medications which cannot be stopped
- Certain liver, kidney, lung, or gastrointestinal conditions
- Poorly controlled hypertension
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 |
|---|---|---|
| Cashews followed by ControlParticipants will receive the active diet with cashew nuts as a daily snack during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the control diet at the same calorie level, but with a control snack instead of cashew nuts during Test Period II. | Other | Crossover 2: Active Diet followed by Control Diet |
| Control followed by CashewsParticipants will receive a controlled diet without cashew nuts during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the active diet at the same calorie level, but with cashew nuts as a daily snack during Test Period II. | Other | Crossover 1: Control Diet followed by Active Diet |
Primary outcome
Change in LDL-C concentration measured in blood
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
5 secondary outcomes
Total cholesterol change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
HDL-cholesterol change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Non-HDL-cholesterol change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Triglyceride change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Total cholesterol/HDL-cholesterol ratio change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
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 1 Nov 2016.
- Derived from this study: PubMed 28356271Mah E, Schulz JA, Kaden VN, Lawless AL, Rotor J, Mantilla LB, Liska DJ. Cashew consumption reduces total and LDL cholesterol: a randomized, crossover, controlled-feeding trial. Am J Clin Nutr. 2017 May;105(5):1070-1078. doi: 10.3945/ajcn.116.150037. Epub 2017 Mar 29.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
Andrea Lawless, MD principal investigator
BioFortis
Questions about this trial
What is this clinical trial studying?
A study of Healthy Volunteers, run by Kraft Heinz Company.
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 3 inclusion and 9 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in LDL-C concentration measured in blood (time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769741, which also lists 1 linked publication.
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 1 Nov 2016.