NCT01007188

Brief Summary

The U.S. Department of Agriculture (USDA) wants to learn more about the number of calories in almonds and the mechanisms of the health effects of almonds. Epidemiologic studies have demonstrated an inverse or no relationship between nut consumption and body weight, despite the fact that nuts are an energy dense food. Intervention studies have shown that consumption of nuts has no effect on body weight or an effect that is significantly less than predicted. Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat and energy loss with nut consumption; however studies with almonds are lacking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 9, 2011

Status Verified

February 1, 2011

Enrollment Period

2 months

First QC Date

November 2, 2009

Last Update Submit

February 8, 2011

Conditions

Healthy

Keywords

almondnutsenergy valuecardiovascular diseasephytonutrientgene expressionenergy value of almondsenergy

Outcome Measures

Primary Outcomes (1)

  • to measure the energy value of almonds in the human diet

    3 weeks

Secondary Outcomes (1)

  • to study molecular mechanisms that may help explain the beneficial health effects of almonds

    3 weeks

Study Arms (3)

1.5PD

ACTIVE COMPARATOR

average American diet plus 1.5 oz per day almonds

Other: 1.5PD almonds

Base

OTHER

average American diet without almonds

Other: Base (without almonds)

3.0PD

ACTIVE COMPARATOR

average American diet plus 3.0 oz per day almonds

Other: 3.0PD almonds

Interventions

1.5PD almondsOTHER

average American diet plus 1.5 oz per day almonds

1.5PD
3.0PD almondsOTHER

average American diet plus 3.0 oz per day almonds

3.0PD
Base (without almonds)OTHER

average American diet without almonds

Base

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25 to 65 years at beginning of study
  • BMI between 20 and 38 kg/m2
  • Fasting glucose \< 126 mg/dl
  • Blood pressure \< 160/100 (controlled with certain medications)
  • Fasting total blood cholesterol \< 280 mg/dl
  • Fasting triglycerides \< 300 mg/dl

You may not qualify if:

  • Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
  • Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
  • History of bariatric or certain other surgeries related to weight control
  • Smokers or other tobacco users (during 6 months prior to the start of the study)
  • Antibiotic use during the intervention or for 3 weeks prior to any intervention period
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
  • Known (self-reported) allergy or adverse reaction to pistachios or other nuts
  • Unable or unwilling to give informed consent or communicate with study staff
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

  • Novotny JA, Gebauer SK, Baer DJ. Discrepancy between the Atwater factor predicted and empirically measured energy values of almonds in human diets. Am J Clin Nutr. 2012 Aug;96(2):296-301. doi: 10.3945/ajcn.112.035782. Epub 2012 Jul 3.

    PMID: 22760558DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Alkalies

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • David J Baer, Ph. D.

    USDA Beltsville Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

March 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 9, 2011

Record last verified: 2011-02

Locations

US(1)