Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments energy restriction, almonds (15% kcal/day)
Sponsor Purdue University
Collaborator Almond Board of California
Start date October 2012
End date May 2016
Trial size 80 participants
Trial identifier NCT02360787, 055-030

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(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.
energy restriction
(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.
energy restriction
almonds (15% kcal/day)

Primary Outcomes

Measure
Anthropometric measurements
time frame: 12 weeks
Blood pressure
time frame: 12 weeks
Post-lunch cognitive function
time frame: 12 weeks

Secondary Outcomes

Measure
Fasting blood biochemistries
time frame: 12 weeks
Dietary intake
time frame: 10 weeks
Appetite ratings
time frame: 12 weeks
Physical activity
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 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 Exclusion Criteria: Those not meeting inclusion criteria.

Additional Information

Official title The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function
Description 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 information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Purdue University.