Impact of Almond Supplementation on Body Composition in Overweight/Obese Minority Adults

January 9, 2020 updated by: Columbia University

Impact of Almond Supplementation, Relative to a Low-fat, High Carbohydrate Control, on Body Composition in Overweight and Obese Black and Hispanic Adults

The purpose of this study is to determine whether introducing almonds into the diet of overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and lowers cardiovascular disease profile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized, controlled study aimed at testing whether almonds, consumed within a free-living, self-selected diet, improve body composition and liver fat, relative to a low-fat/high-carbohydrate cereal bar (LF-HC) in overweight and obese Blacks and Hispanics. A secondary aim is to determine whether almond consumption will lead to an overall lower CVD risk profile.

Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily (2-3 oz) or a high-carbohydrate cereal bar (2 g of fat or less per 100 kcal) providing an equivalent amount of calories. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their food supplement as a mid-afternoon snack and the rest at a meal of their choice.

At the baseline visit, participants will be given a 2-week supply of their allocated food supplement and will obtain additional supplies at bi-weekly visits for the first 8 weeks. After the week 8 visit, participants will be given monthly rations of their food supplement, either almonds or LF-HC cereal bar, and will be asked to come to research center every 4 weeks to obtain their next supply. At those visits, body weight and blood pressure will be measured and participants will turn in weekly dietary diaries, reporting their supplement intake. Participants will also receive one random phone call every 4 weeks to provide a 24-h recall. This recall will be used as an index of dietary quality but also as a compliance check with dietary supplements. In addition, 3-day food records will be collected prior to the start of the study and during the final week to assess any dietary changes due to the intervention. A food frequency questionnaire will also be administered at screening and endpoint of the study. This food-frequency questionnaire will target nut consumption.

At the end of the study, intention to continue eating almonds or a low-fat diet will be assessed using questions adapted from de Bruijn et al. Participants in the almond group will be asked the following questions: (1) "I intend to include almonds in my diet" (+2 = yes, definitely; -2 = no, definitely); (2) "How certain are you that you will include almonds in your diet?" (+2 = very certain; -2 = very uncertain); (3) "Including almonds in my diet is" (instrumental attitude: +3 = healthy; -3 = unhealthy; affective attitude: +3 = pleasant; -3 = unpleasant); (4) "I find including almonds in my diet" (perceived behavioral control: +3 = easy; -3 = difficult). Corresponding questions for the control group will replace "include almonds" with "reduce the amount of fat". Participants will be called 4 weeks later to obtain information on their actual almond and fat intakes by questionnaire and 24-h recall.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Nutrition Obesity Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Black and/or Hispanic
  • Body Mass Index (BMI) 25-35 kg/m^2
  • Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
  • Body weight less than 300 pounds
  • Adherence to an acceptable form of contraception (for women)
  • If taking medicine, dose must have been stable before study; must remain on same medication and dose throughout study.

Exclusion Criteria:

  • Diabetes
  • Uncontrolled hypertension (high blood pressure)
  • Cardiovascular disease
  • Weight loss attempted in past 3 months
  • Eating disorder
  • Stroke, seizure disorder, or significant neurological disease
  • Unstable of uncontrolled medical illness including active malignancies within past 5 years
  • Untreated or unstable hypothyroidism
  • Hyperthyroidism
  • Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
  • Alcohol or substance abuse in the past 6 months
  • Pregnant, planning pregnancy in the next 6 months, or breast-feeding
  • Participating or planning to participate in a commercial diet or behavior modification program (ex: Weight Watchers)
  • Allergy or sensitivity to wheat/grain products or nuts
  • Gastrointestinal disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Almond
Dietary supplement: Almond
Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily almond supplement as a mid-afternoon snack and the rest at a meal of their choice.
ACTIVE_COMPARATOR: Cereal Bar
Dietary supplement: Cereal Bar
Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from cereal bars daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily cereal bar supplement as a mid-afternoon snack and the rest at a meal of their choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body Composition
Time Frame: Baseline and endpoint visits (Weeks 0 and 24)
MRI will be used to provide information on total adipose tissue and all adipose tissue sub-compartments: visceral, subcutaneous, intermuscular.
Baseline and endpoint visits (Weeks 0 and 24)
Change in liver Fat
Time Frame: Baseline and endpoint visits (weeks 0 and 24)
MRS will be used to provide information on liver adiposity.
Baseline and endpoint visits (weeks 0 and 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardio-metabolic risk profile
Time Frame: Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Blood draw and analyses will be used to measure total and low-density lipoprotein cholesterol, triglycerides, high-density lipoprotein cholesterol, glucose, insulin, and inflammatory markers.
Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Change in brain-derived neutrophic factor (BDNF)
Time Frame: Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Blood draw and analyses will be used measure BDNF.
Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Change in quality of life
Time Frame: Baseline and endpoint visits (weeks 0 and 24)
SF-36 questionnaire will be used to assess quality of life.
Baseline and endpoint visits (weeks 0 and 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Almond Board of California

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, Ph.D., College of Physicians & Surgeons, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (ESTIMATE)

January 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAN4353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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