NCT01886326

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

June 19, 2013

Last Update Submit

June 21, 2013

Conditions

Keywords

Obesityenergy balancevarietynut intake

Outcome Measures

Primary Outcomes (9)

  • Change in Weight

    2, 4, 6, 8, 10, and 12 weeks

  • Change in Blood Lipids

    4, 8, and 12 weeks

  • Change in Blood Pressure

    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.

    12 weeks

  • Change in Body Composition

    2, 4, 6, 8, 10, and 12 weeks

  • Change in Fasting Blood Glucose

    4, 8, and 12 weeks

  • Change in Cortisol

    4, 8, and 12 weeks

  • Change in Insulin

    4, 8, and 12 weeks

  • Change in Pulse

    2, 4, 6, 8, 10, and 12 weeks

Secondary Outcomes (5)

  • Personality Questionnaires

    At baseline visit

  • Flavor attribute liking measures

    At baseline

  • Compliance

    12 weeks

  • Appetitive Ratings

    4, 8, and 12 weeks

  • Consumption Parameters

    12 weeks

Study Arms (6)

Consumption of 42 g of salted peanuts

EXPERIMENTAL

Consumption of 42 grams of peanuts daily

Other: Consumption of 42 grams of peanuts daily

Consumption of 42 g of unsalted peanuts

EXPERIMENTAL

Consumption of 42 grams of peanuts daily

Other: Consumption of 42 grams of peanuts daily

Consumption of 42 g of spicy peanuts

EXPERIMENTAL

Consumption of 42 grams of peanuts daily

Other: Consumption of 42 grams of peanuts daily

Consumption of 42 g of honey peanuts

EXPERIMENTAL

Consumption of 42 grams of peanuts daily

Other: Consumption of 42 grams of peanuts daily

Consumption of 42 g of 3 diff. varieties

EXPERIMENTAL

Consumption of 42 grams of peanuts daily

Other: Consumption of 42 grams of peanuts daily

Consumption of 42 g of var. of types

EXPERIMENTAL

Consumption of 42 grams of peanuts daily

Other: Consumption of 42 grams of peanuts daily

Interventions

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

Consumption of 42 g of 3 diff. varietiesConsumption of 42 g of honey peanutsConsumption of 42 g of salted peanutsConsumption of 42 g of spicy peanutsConsumption of 42 g of unsalted peanutsConsumption of 42 g of var. of types

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (2)

  • 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.

  • Jones 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.

MeSH Terms

Conditions

ObesityOverweightHyperlipidemias

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Study Officials

  • Richard D Mattes, RD, MPH, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Prof. Foods and Nutrition

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 25, 2013

Study Start

February 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations