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

NCT02347007 | Completed DMC

• 1 other identifier: AAAN4353
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Overweight; Fatty Liver; Metabolic Syndrome X

Keywords

Obesity; Overweight; Body Weight; Cardiovascular Diseases; Cholesterol; Almonds; Visceral Adiposity; Quality of Life; Hispanic Americans; African Continental Ancestry Group; Metabolic Syndrome X

Outcome Measures

Primary Outcomes (2)

• Change in body Composition

  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

  MRS will be used to provide information on liver adiposity.

  Baseline and endpoint visits (weeks 0 and 24)

Secondary Outcomes (3)

• Change in cardio-metabolic risk profile

  Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)

• Change in brain-derived neutrophic factor (BDNF)

  Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)

• Change in quality of life

  Baseline and endpoint visits (weeks 0 and 24)

Study Arms (2)

Almond

EXPERIMENTAL

Dietary Supplement: Almond

Cereal Bar

ACTIVE COMPARATOR

Dietary Supplement: Cereal Bar

Interventions

Almond DIETARY_SUPPLEMENT

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.

Almond

Cereal Bar DIETARY_SUPPLEMENT

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.

Cereal Bar

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Almond Board of California: collaborator

Study Sites (1)

New York Nutrition Obesity Research Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Fatty Liver; Metabolic Syndrome; Body Weight; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Marie-Pierre St-Onge, Ph.D.

  College of Physicians & Surgeons, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 27, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: March 1, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)