ObesityNCT01886326
Eating Peanuts for Health
A study testing Consumption of 42 grams of peanuts daily in people with Obesity and Overweight, run by Purdue University at 1 site in United States.
Trial summary
Evidence is accumulating that peanut consumption confers health benefits, such as reduction of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain are widespread. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Hyperlipidemia
- What is being tested?
- Consumption of 42 grams of peanuts daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2012
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 50 years of age
- Weight stable (< 3 kg weight change within last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months)
- Constant habitual diet patterns within last 3 months
- Willingness to eat all test foods (peanuts daily for 12 weeks)
- No allergy to foods provided in the study (peanuts)
Show all 11Show fewer
- Not a daily peanut or tree nut consumer
- Not planning to change use of medications known to influence appetite or metabolism
- Not diabetic or hypertensive
- No history of gastrointestinal pathology
- Non-smoker for one year or more
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peanut Consumption and Human Weight Management
Evidence is accumulating that peanut consumption confers health benefits, such as reduction of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain are widespread. Although research indicates that other characteristics of peanuts offset these properties, and that peanuts may be incorporated into diets without posing a threat to weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare providers, and consumers. Furthermore, worry exists that eating salted peanuts may elevate blood pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears create substantial obstacles to increased peanut consumption.
Recommendations to increase peanut consumption may be made, but if they are not followed, there will be no impact on health. Additional knowledge is needed on: (1) the acceptability of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The proposed research will examine the acceptability of long-term inclusion of a single form versus varied forms of peanuts in the diet. It is expected that responses will be varied among individuals with different personality characteristics (e.g., prefer sweet versus savory foods, hedonic versus non-hedonic eaters). A better understanding of how different segments of the population choose to include peanuts in their diet and how to optimize long-term consumption should provide insights for better marketing and improved health. Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add credibility to the evidence that peanuts do not cause weight gain, as well as reinforce recommendations to increase peanut consumption for their health benefits.
- Conditions
- Obesity, Overweight, Hyperlipidemia
- Being tested
- Consumption of 42 grams of peanuts daily
- Keywords
- Obesity, energy balance, variety, nut intake
- Medical subject headings
- Obesity, Overweight, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of 42 grams of peanuts dailyOther
Consumption of the given 42 grams of peanuts daily without instructions for use (i.e. with/without meals, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Consumption of 42 g of salted peanuts | Experimental | Consumption of 42 grams of peanuts daily Receives: Other: Consumption of 42 grams of peanuts daily |
| Consumption of 42 g of unsalted peanuts | Experimental | Consumption of 42 grams of peanuts daily Receives: Other: Consumption of 42 grams of peanuts daily |
| Consumption of 42 g of spicy peanuts | Experimental | Consumption of 42 grams of peanuts daily Receives: Other: Consumption of 42 grams of peanuts daily |
| Consumption of 42 g of honey peanuts | Experimental | Consumption of 42 grams of peanuts daily Receives: Other: Consumption of 42 grams of peanuts daily |
| Consumption of 42 g of 3 diff. varieties | Experimental | Consumption of 42 grams of peanuts daily Receives: Other: Consumption of 42 grams of peanuts daily |
| Consumption of 42 g of var. of types | Experimental | Consumption of 42 grams of peanuts daily Receives: Other: Consumption of 42 grams of peanuts daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: 2, 4, 6, 8, 10, and 12 weeks
Change in Blood Lipids
Measured: 4, 8, and 12 weeks
Change in Blood Pressure
Measured: 2, 4, 6, 8, 10, and 12 weeks
Change in Hedonics of peanut consumption
Participants will rate their liking of the sample each day using a visual analog scale.
Measured: 12 weeks
Change in Body Composition
Measured: 2, 4, 6, 8, 10, and 12 weeks
Change in Fasting Blood Glucose
Measured: 4, 8, and 12 weeks
Change in Cortisol
Measured: 4, 8, and 12 weeks
Change in Insulin
Measured: 4, 8, and 12 weeks
Change in Pulse
Measured: 2, 4, 6, 8, 10, and 12 weeks
Secondary outcomes (5)
Personality Questionnaires
Measured: At baseline visit
Flavor attribute liking measures
Measured: At baseline
Compliance
Participants will self-report compliance to study protocol using record sheets.
Measured: 12 weeks
Appetitive Ratings
Collected on handheld computer
Measured: 4, 8, and 12 weeks
Consumption Parameters
Participants will note if peanuts were eaten as a meal or snack, at what time, and with what other foods daily.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, RD, MPH, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886326
- Sponsor's protocol ID
- 0912008773
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2013
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones JB, Provost M, Keaver L, Breen C, Ludy MJ, Mattes RD. Effects of daily consumption of one or varied peanut flavors on acceptance and intake. Appetite. 2014 Nov;82:208-12. doi: 10.1016/j.appet.2014.07.023. Epub 2014 Jul 23.
PubMed 25064672Jones JB, Provost M, Keaver L, Breen C, Ludy MJ, Mattes RD. A randomized trial on the effects of flavorings on the health benefits of daily peanut consumption. Am J Clin Nutr. 2014 Mar;99(3):490-6. doi: 10.3945/ajcn.113.069401. Epub 2013 Dec 18.
PubMed 24351876
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Consumption and Human Weight Management
- ClinicalTrials.gov ID
- NCT01886326
- Acronym / sponsor ID
- 0912008773
- Conditions
- Obesity, Overweight, Hyperlipidemia
- Keywords
- Obesity, energy balance, variety, nut intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Feb 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Jun 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.
Evidence is accumulating that peanut consumption confers health benefits, such as reduction of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain are widespread. Although research indicates that other characteristics of peanuts offset these properties, and that peanuts may be incorporated into diets without posing a threat to weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare providers, and consumers. Furthermore, worry exists that eating salted peanuts may elevate blood pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears create substantial obstacles to increased peanut consumption.
Recommendations to increase peanut consumption may be made, but if they are not followed, there will be no impact on health. Additional knowledge is needed on: (1) the acceptability of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The proposed research will examine the acceptability of long-term inclusion of a single form versus varied forms of peanuts in the diet. It is expected that responses will be varied among individuals with different personality characteristics (e.g., prefer sweet versus savory foods, hedonic versus non-hedonic eaters). A better understanding of how different segments of the population choose to include peanuts in their diet and how to optimize long-term consumption should provide insights for better marketing and improved health. Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add credibility to the evidence that peanuts do not cause weight gain, as well as reinforce recommendations to increase peanut consumption for their health benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Consumption of 42 g of salted peanuts | Experimental | Other: Consumption of 42 grams of peanuts dailyConsumption of 42 grams of peanuts daily |
| Consumption of 42 g of unsalted peanuts | Experimental | Other: Consumption of 42 grams of peanuts dailyConsumption of 42 grams of peanuts daily |
| Consumption of 42 g of spicy peanuts | Experimental | Other: Consumption of 42 grams of peanuts dailyConsumption of 42 grams of peanuts daily |
| Consumption of 42 g of honey peanuts | Experimental | Other: Consumption of 42 grams of peanuts dailyConsumption of 42 grams of peanuts daily |
| Consumption of 42 g of 3 diff. varieties | Experimental | Other: Consumption of 42 grams of peanuts dailyConsumption of 42 grams of peanuts daily |
| Consumption of 42 g of var. of types | Experimental | Other: Consumption of 42 grams of peanuts dailyConsumption of 42 grams of peanuts daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Between 18 and 50 years of age
- Weight stable (< 3 kg weight change within last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months)
- Constant habitual diet patterns within last 3 months
- Willingness to eat all test foods (peanuts daily for 12 weeks)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Consumption of 42 grams of peanuts dailyConsumption of the given 42 grams of peanuts daily without instructions for use (i.e. with/without meals, etc.) | Other | Consumption of 42 g of 3 diff. varieties, Consumption of 42 g of honey peanuts, Consumption of 42 g of salted peanuts, Consumption of 42 g of spicy peanuts, Consumption of 42 g of unsalted peanuts, Consumption of 42 g of var. of types |
Primary outcome
Change in Weight
Time frame: 2, 4, 6, 8, 10, and 12 weeks
Change in Blood Lipids
Time frame: 4, 8, and 12 weeks
Change in Blood Pressure
Time frame: 2, 4, 6, 8, 10, and 12 weeks
Change in Hedonics of peanut consumption
Time frame: 12 weeks
Participants will rate their liking of the sample each day using a visual analog scale.
Change in Body Composition
Time frame: 2, 4, 6, 8, 10, and 12 weeks
Change in Fasting Blood Glucose
Time frame: 4, 8, and 12 weeks
Change in Cortisol
Time frame: 4, 8, and 12 weeks
Change in Insulin
Time frame: 4, 8, and 12 weeks
Change in Pulse
Time frame: 2, 4, 6, 8, 10, and 12 weeks
5 secondary outcomes
Personality Questionnaires
Time frame: At baseline visit
Flavor attribute liking measures
Time frame: At baseline
Compliance
Time frame: 12 weeks
Appetitive Ratings
Time frame: 4, 8, and 12 weeks
Consumption Parameters
Time frame: 12 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 25 Jun 2013.
- Derived from this study: PubMed 25064672Jones JB, Provost M, Keaver L, Breen C, Ludy MJ, Mattes RD. Effects of daily consumption of one or varied peanut flavors on acceptance and intake. Appetite. 2014 Nov;82:208-12. doi: 10.1016/j.appet.2014.07.023. Epub 2014 Jul 23.
- Derived from this study: PubMed 24351876Jones JB, Provost M, Keaver L, Breen C, Ludy MJ, Mattes RD. A randomized trial on the effects of flavorings on the health benefits of daily peanut consumption. Am J Clin Nutr. 2014 Mar;99(3):490-6. doi: 10.3945/ajcn.113.069401. Epub 2013 Dec 18.
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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.
Richard D Mattes, RD, MPH, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of 42 grams of peanuts daily in people with Obesity and Overweight, run by Purdue 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 11 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 25 Jun 2013. 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?
Change in Weight (time frame: 2, 4, 6, 8, 10, and 12 weeks). The study lists 9 primary outcomes in all. 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 NCT01886326, which also lists 2 linked publications.
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 25 Jun 2013.