Effectiveness of Changing Dietary Fat on Weight Loss

NCT02953158 | Completed

• 1 other identifier: IRB#16-001157
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two energy reduced diets; one diet will include one Haas avocado/day while the other diet will follow the usual American dietary pattern. All subjects will receive a dietary plan that reduces their usual intake by 500kcal/day with the same percentage of fat, protein and carbohydrates. The results from this study may help to explain if eating one Haas avocado/day can achieve at least equivalent weight loss when compared to the usual American diet.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Change in weight loss after consumption of 1 Haas Avocado per day with a hypocaloric diet

  Individuals will be randomly assigned to a hypocaloric (500 Cal deficit) meal plans with or without one Hass avocado a day for 12 weeks.

  Baseline to 12 weeks

Secondary Outcomes (1)

• Change in gut microbiome

  Baseline to 12 weeks

Study Arms (2)

Haas Avocado

EXPERIMENTAL

Haas Avocado commercially available Behavioral: Dietary recommendations Recommendation: a hypocaloric weight loss diet

Other: Haas Avocado

Dietary Counseling

ACTIVE COMPARATOR

Behavioral: Dietary Counseling Recommendation: equally hypocaloric usual American diet.

Behavioral: Dietary Counseling

Interventions

Haas Avocado OTHER

Hypocaloric weight loss diet

Also known as: Avocado

Haas Avocado

Dietary Counseling BEHAVIORAL

Dietary Counseling

Dietary Counseling

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between the ages of 20-60 years of age.
• Body Mass Index (BMI) 27.0 -35.0 kg/m2.
• Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical®), sibutramine (Meridia®) or phentermine etc.) If subject is willing to discontinue prescription medication(s) immediately and willing to refrain from taking medication(s) for duration of study, he/she may be enrolled after a four-week washout period.
• Not currently taking any over-the-counter weight loss supplement(s) or appetite suppressants (including OTC stimulants). If subject is willing to discontinue supplement(s) immediately and willing to refrain from taking supplement(s) for duration of study, he/she may be enrolled after a two-week washout period.
• 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. TOPS, Overeaters Anonymous) or participating in any food preparation/delivery program (eg Nutrisystems). 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 complete Dual X-Ray Absorptiometry (DXA) procedure.
• 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.
• Diagnosed with Type I or Type II diabetes. History of major surgery within three months of enrollment.
• History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
• Presence of implanted cardiac defibrillator or pacemaker.
• Uncontrolled hypertension/high blood pressure.
• History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy).
• Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
• History of inflammatory bowel disease.
• Following a diet that requires the elimination of FODMAPS•
• Following a specific diet that restricts specific food groups (eg. Paleo) or with extreme macronutrient ratios (carbohydrates, fats and proteins). • History of fatty liver.
• History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Hass Avocado Board: collaborator

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location

Related Publications (1)

• Henning SM, Yang J, Woo SL, Lee RP, Huang J, Rasmusen A, Carpenter CL, Thames G, Gilbuena I, Tseng CH, Heber D, Li Z. Hass Avocado Inclusion in a Weight-Loss Diet Supported Weight Loss and Altered Gut Microbiota: A 12-Week Randomized, Parallel-Controlled Trial. Curr Dev Nutr. 2019 Jun 12;3(8):nzz068. doi: 10.1093/cdn/nzz068. eCollection 2019 Aug.

  PMID: 31367691 DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Zhaoping Li, MD, PhD

  UCLA Center for Human Nutrition

  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

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: November 2, 2016
• Study Start: January 3, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)