Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02347007
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date March 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2