Obesity Clinical Trial
Official title:
Peanut Consumption and Human Weight Management
Verified date | June 2013 |
Source | Purdue University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Purdue University | West Lafayette | Indiana |
Lead Sponsor | Collaborator |
---|---|
Purdue University | United States Agency for International Development (USAID) |
United States,
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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