The Effect of a Healthy Snack on Body Weight and Composition

NCT03159689 | Completed

• 1 other identifier: 17-000361
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The results from this study may help to explain if incorporating mixed nuts in a reduced calorie diet will lead to weight loss.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Weight loss as determined by body composition and body mass index

  baseline to Week 24

Study Arms (2)

Mixed Tree Nuts

EXPERIMENTAL

a hypo caloric weight loss dietary plan with mixed tree nuts

Other: Mixed Tree Nuts

Pretzels

ACTIVE COMPARATOR

a hypo caloric weight loss dietary plan with pretzels

Other: Pretzels

Interventions

Mixed Tree Nuts OTHER

Individuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz mixed tree nuts

Mixed Tree Nuts

Pretzels OTHER

Individuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz pretzels

Pretzels

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between the ages of 40-60 years of age (female premenopausal).
• Body Mass Index (BMI) 27.0-35.0 kg/m2.
• Not currently taking a prescription or over the counter medication for weight loss.
• Not currently enrolled in any commercial weight loss program (e.g. Jenny Craig, Weight Watchers), internet based weight-management program, self-help group (e.g. Overeaters Anonymous) or participating in any food preparation/delivery program. If subject is willing to discontinue program immediately and willing to refrain from program for duration of study, he/she may be included after a two-week washout period.
• Willing to keep and turn in a daily log/compliance book as required by study protocol.
• Willingness and ability to make all scheduled appointments.
• Willing to follow dietary recommendations required by study protocol.
• Willingness to periodically have small blood samples drawn as indicated in the protocol.

You may not qualify if:

• More than a 5-pound weight gain or weight loss within the 3 months prior to enrollment in the study.
• History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
• History of Type I or Type II diabetes, major surgery, heart problems (e.g. angina, bypass surgery, MI, etc.), presence of implanted cardiac defibrillator or pacemaker, uncontrolled hypertension/high blood pressure, gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease, inflammatory bowel disease, fatty liver or cancer within three months of enrollment
• History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy).
• Following a diet that requires the elimination of FODMAPS (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols)
• Following a specific diet that restricts specific food groups (eg. Paleo) or with extreme macronutrient ratios (carbohydrates, fats and proteins).
• History of clinically diagnosed eating disorders including anorexia nervosa, bulimia nervosa or binge eating disorder.
• Women who are pregnant, lactating or trying to become pregnant.
• Currently taking any prescription medication for less than 3 months.
• Currently taking any prescriptions drugs or supplements that may impact weight regulation
• Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation or history of alcohol dependency.
• Known allergy to almond, pistachio, walnut, macadamia, cashews, hazelnuts, or pecan nuts.
• Participation in another clinical trial within 30 days prior to enrollment.
• Currently smoking cigarettes.
• Any known clinically significant food allergy or intolerance.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: February 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)