NCT02360787

Brief Summary

The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

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

October 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

3.6 years

First QC Date

November 20, 2014

Last Update Submit

January 16, 2018

Conditions

OverweightObesity

Keywords

AlmondsEnergy restrictionObesityBody weightBody fatBlood pressureCognitive function

Outcome Measures

Primary Outcomes (3)

  • Anthropometric measurements

    Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks

    12 weeks

  • Blood pressure

    Blood pressure measurements assessed at baseline, week-4, week-8 and week-12

    12 weeks

  • Post-lunch cognitive function

    Cognitive function assessments will be performed after a standard lunch at baseline and week 12

    12 weeks

Secondary Outcomes (4)

  • Fasting blood biochemistries

    12 weeks

  • Dietary intake

    10 weeks

  • Appetite ratings

    12 weeks

  • Physical activity

    12 weeks

Study Arms (2)

Energy restriction

EXPERIMENTAL

Energy restriction (-500 kcal/day) (N=40), where participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits to support weight loss. Participants will also be asked to avoid all nuts during the intervention period.

Behavioral: Energy restriction

Energy restriction with almonds

EXPERIMENTAL

Energy restriction (-500 kcal/day) with dry-roasted, lightly salted almonds supplying 15% of estimated energy requirement. Participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits. Energy from almonds will be accounted for during dietary modeling so that a 500 kcal/day deficit is achieved.

Behavioral: Energy restrictionBehavioral: Almonds (15% kcal/day)

Interventions

Energy restrictionBEHAVIORAL
Energy restrictionEnergy restriction with almonds
Almonds (15% kcal/day)BEHAVIORAL
Energy restriction with almonds

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult participants
  • Overweight or obese (BMI 25-40 kg/m2)
  • Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples
  • No nut allergies
  • Willing to comply to study protocol and to eat test meals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (2)

  • Dhillon J, Ferreira CR, Sobreira TJP, Mattes RD. Multiple Reaction Monitoring Profiling to Assess Compliance with an Almond Consumption Intervention. Curr Dev Nutr. 2017 Sep 6;1(9):e001545. doi: 10.3945/cdn.117.001545. eCollection 2017 Sep.

    PMID: 29955720DERIVED

  • Dhillon J, Tan SY, Mattes RD. Almond Consumption during Energy Restriction Lowers Truncal Fat and Blood Pressure in Compliant Overweight or Obese Adults. J Nutr. 2016 Dec;146(12):2513-2519. doi: 10.3945/jn.116.238444. Epub 2016 Nov 2.

    PMID: 27807041DERIVED

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor Nutrition Science

Study Record Dates

First Submitted

November 20, 2014

First Posted

February 11, 2015

Study Start

October 1, 2012

Primary Completion

May 1, 2016

Study Completion

August 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(1)