NCT02034383

Brief Summary

The objective of this study is to measure the effect of processing (roasting, slicing, or grinding) on the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds.

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 2014

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

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

January 9, 2014

Last Update Submit

February 12, 2015

Conditions

HealthyFocus: Effect of Processing on Energy Value of Almonds

Outcome Measures

Primary Outcomes (1)

  • Metabolizable Energy

    The metabolizable energy value of almonds and almond butter will be calculated based on the chemical composition and energy content of the consumed diet and excreta.

    End of each 3-week diet period

Secondary Outcomes (3)

  • Digestibility

    End of each 3-week diet period

  • Almond nutrient metabolism

    End of each 3-week diet period

  • Biomarkers of cardiovascular disease

    End of each 3-week diet period

Study Arms (5)

Control

EXPERIMENTAL

Diet will consist of a controlled diet without almonds for 3 weeks.

Other: Control

Whole Almonds

EXPERIMENTAL

Diet will consist of a controlled diet with whole almonds for 3 weeks.

Other: Whole Almonds

Roasted Whole Almonds

EXPERIMENTAL

Diet will consist of a controlled diet with roasted whole almonds for 3 weeks.

Other: Roasted Whole Almonds

Diced Almonds

EXPERIMENTAL

Diet will consist of a controlled diet with diced almonds for 3 weeks.

Other: Diced Almonds

Almond Butter

EXPERIMENTAL

Diet will consist of a controlled diet with almond butter for 3 weeks.

Other: Almond Butter

Interventions

ControlOTHER

Controlled diet for 3 weeks with 0 servings/day of almonds.

Control
Whole AlmondsOTHER

Controlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds.

Whole Almonds
Roasted Whole AlmondsOTHER

Controlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds.

Roasted Whole Almonds
Diced AlmondsOTHER

Controlled diet for 3 weeks with 1.5 servings/day of diced almonds.

Diced Almonds
Almond ButterOTHER

Controlled diet for 3 weeks with 1.5 servings/day of almond butter.

Almond Butter

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25 to 75 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
  • Women who have given birth during the previous 12 months
  • Pregnant women or women who plan to become pregnant or become pregnant during the study
  • Lactating women
  • 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)
  • 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
  • Known (self-reported) allergy or adverse reaction to almonds 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 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: 22760558BACKGROUND

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Physiologist

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

US(1)