Overview

This trial is active, not recruiting.

Conditions obesity, overweight, fatty liver, metabolic syndrome x
Treatments almond, cereal bar
Sponsor Columbia University
Collaborator Almond Board of California
Start date October 2014
End date June 2016
Trial size 26 participants
Trial identifier NCT02347007, AAAN4353

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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.

Primary Outcomes

Measure
Change in body Composition
time frame: Baseline and endpoint visits (Weeks 0 and 24)
Change in liver Fat
time frame: Baseline and endpoint visits (weeks 0 and 24)

Secondary Outcomes

Measure
Change in cardio-metabolic risk profile
time frame: 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)
Change in quality of life
time frame: Baseline and endpoint visits (weeks 0 and 24)

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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.

Additional Information

Official title Impact of Almond Supplementation, Relative to a Low-fat, High Carbohydrate Control, on Body Composition in Overweight and Obese Black and Hispanic Adults
Principal investigator Marie-Pierre St-Onge, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Columbia University.