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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01886326
Other study ID # 0912008773
Secondary ID
Status Completed
Phase N/A
First received June 19, 2013
Last updated June 21, 2013
Start date February 2010
Est. completion date May 2012

Study information

Verified date June 2013
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- 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)

- 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Consumption of 42 grams of peanuts daily
Consumption of the given 42 grams of peanuts daily without instructions for use (i.e. with/without meals, etc.)

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Purdue University United States Agency for International Development (USAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Weight 2, 4, 6, 8, 10, and 12 weeks No
Primary Change in Blood Lipids 4, 8, and 12 weeks No
Primary Change in Blood Pressure 2, 4, 6, 8, 10, and 12 weeks No
Primary Change in Hedonics of peanut consumption Participants will rate their liking of the sample each day using a visual analog scale. 12 weeks No
Primary Change in Body Composition 2, 4, 6, 8, 10, and 12 weeks No
Primary Change in Fasting Blood Glucose 4, 8, and 12 weeks No
Primary Change in Cortisol 4, 8, and 12 weeks No
Primary Change in Insulin 4, 8, and 12 weeks No
Primary Change in Pulse 2, 4, 6, 8, 10, and 12 weeks No
Secondary Personality Questionnaires At baseline visit No
Secondary Flavor attribute liking measures At baseline No
Secondary Compliance Participants will self-report compliance to study protocol using record sheets. 12 weeks No
Secondary Appetitive Ratings Collected on handheld computer 4, 8, and 12 weeks No
Secondary Consumption Parameters Participants will note if peanuts were eaten as a meal or snack, at what time, and with what other foods daily. 12 weeks No
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