OverweightHAWLSNCT02953158
Effectiveness of Changing Dietary Fat on Weight Loss
A study testing Haas Avocado and Dietary Counseling in people with Overweight, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Haas Avocado and Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Currently taking any prescriptions drugs 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.
- Known allergy to avocados.
- History of alcohol dependency.
- Participation in another clinical trial within 30 days prior to enrollment.
- Currently smoking cigarettes.
- Any clinically significant food allergy.
- Currently consuming an average of >1 avocado per week.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90024
About this study
Official title: A Comparison of A Hypocaloric Diet Plus One Hass Avocado Per Day Versus An Equally Hypocaloric Diet for Weight Loss, Satiety, Changes in Body Composition, and Risk Factors for Chronic Disease (HAWLS)
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.
Read the detailed description
Overweight and obesity in the United States and other industrialized countries represents a significant and growing health problem. Individuals who are overweight or obese increase their risk of coronary heart disease (CHD), diabetes (T2D), and the metabolic syndrome. Obesity affects both genders and every ethnicity in the United States. The prevalence of obesity in the United States is currently 32.2% in adult men and 35.5% in adult women. The most recent evidence indicates that 33.8% of adults, over 66 million American adults, are obese (30 million men and 36 million women) while an additional 74 million (42 million men and 32 million women) are overweight. The prevalence of obesity has grown a shocking 40% over the last 30 years.
These problems are truly global in nature. In European countries obesity ranges from 20-30% of the population and is even higher in Australia, South America, and Polynesia. The World Health Organization estimates that there will be over 1.5 billion obese individuals worldwide by 2020 if current trends continue.
Calorie controlled diets have routinely been demonstrated to help in both short and long-term weight reduction in individuals who are overweight or obese. In particular, hypocaloric diets, with a calorie reduction of 500 kcals per day have been shown in numerous studies to result in safe and effective weight loss.
It is important for individuals who are following weight loss programs to maintain healthy nutritional patterns, to maintain or improve their dietary quality. Haas avocados can play a significant role as part of a healthy weight loss program and help individuals not only improve their dietary quality, but also lower their risk of chronic diseases such as CHD, T2D, and the metabolic syndrome. Avocados are high in monounsaturated fat, dietary fiber, and a variety of other important phytochemicals such as lutein, vitamin E, niacin and folate. Despite these multiple nutritional benefits, myths exist that avocados may be fattening due to their fat and calorie content and therefore, should be avoided by people trying to lose weight.
The current research trial is designed to compare two energy reduced (hypocaloric) diets. One diet will include one Hass avocado/day, while achieving a 500 kcal/day energy reduction. The other diet will follow a usual American diet pattern, but will also include an energy restriction of 500 kcals/day. Parameters to be explored include weight loss, satiety, dietary quality, changes in body composition and risk factors for chronic disease.
- Conditions
- Overweight
- Being tested
- Haas Avocado, Dietary Counseling
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haas AvocadoOther
Also called Avocado
Hypocaloric weight loss diet
Dietary CounselingBehavioural
Dietary Counseling
| Study group | Role | What they receive |
|---|---|---|
| Haas Avocado | Experimental | Haas Avocado commercially available Behavioral: Dietary recommendations Recommendation: a hypocaloric weight loss diet Receives: Other: Haas Avocado |
| Dietary Counseling | Active comparator | Behavioral: Dietary Counseling Recommendation: equally hypocaloric usual American diet. Receives: Behavioral: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Change in gut microbiome
Individuals will be randomly assigned to a hypocaloric (500 Cal deficit) meal plans with or without one Hass avocado a day for 12 weeks.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start3 Jan 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, UCLA Center for Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953158
- Sponsor's protocol ID
- IRB#16-001157
- Acronym
- HAWLS
- Status last verified
- Dec 2019
- First submitted
- 6 Oct 2016
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31367691
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of A Hypocaloric Diet Plus One Hass Avocado Per Day Versus An Equally Hypocaloric Diet for Weight Loss, Satiety, Changes in Body Composition, and Risk Factors for Chronic Disease (HAWLS)
- ClinicalTrials.gov ID
- NCT02953158
- Acronym / sponsor ID
- HAWLS / IRB#16-001157
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overweight and obesity in the United States and other industrialized countries represents a significant and growing health problem. Individuals who are overweight or obese increase their risk of coronary heart disease (CHD), diabetes (T2D), and the metabolic syndrome. Obesity affects both genders and every ethnicity in the United States. The prevalence of obesity in the United States is currently 32.2% in adult men and 35.5% in adult women. The most recent evidence indicates that 33.8% of adults, over 66 million American adults, are obese (30 million men and 36 million women) while an additional 74 million (42 million men and 32 million women) are overweight. The prevalence of obesity has grown a shocking 40% over the last 30 years.
These problems are truly global in nature. In European countries obesity ranges from 20-30% of the population and is even higher in Australia, South America, and Polynesia. The World Health Organization estimates that there will be over 1.5 billion obese individuals worldwide by 2020 if current trends continue.
Calorie controlled diets have routinely been demonstrated to help in both short and long-term weight reduction in individuals who are overweight or obese. In particular, hypocaloric diets, with a calorie reduction of 500 kcals per day have been shown in numerous studies to result in safe and effective weight loss.
It is important for individuals who are following weight loss programs to maintain healthy nutritional patterns, to maintain or improve their dietary quality. Haas avocados can play a significant role as part of a healthy weight loss program and help individuals not only improve their dietary quality, but also lower their risk of chronic diseases such as CHD, T2D, and the metabolic syndrome. Avocados are high in monounsaturated fat, dietary fiber, and a variety of other important phytochemicals such as lutein, vitamin E, niacin and folate. Despite these multiple nutritional benefits, myths exist that avocados may be fattening due to their fat and calorie content and therefore, should be avoided by people trying to lose weight.
The current research trial is designed to compare two energy reduced (hypocaloric) diets. One diet will include one Hass avocado/day, while achieving a 500 kcal/day energy reduction. The other diet will follow a usual American diet pattern, but will also include an energy restriction of 500 kcals/day. Parameters to be explored include weight loss, satiety, dietary quality, changes in body composition and risk factors for chronic disease.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haas Avocado | Experimental | Other: Haas AvocadoHaas Avocado commercially available Behavioral: Dietary recommendations Recommendation: a hypocaloric weight loss diet |
| Dietary Counseling | Active comparator | Behavioral: Dietary CounselingBehavioral: Dietary Counseling Recommendation: equally hypocaloric usual American diet. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haas AvocadoAlso: AvocadoHypocaloric weight loss diet | Other | Haas Avocado |
| Dietary CounselingDietary Counseling | Behavioural | Dietary Counseling |
Primary outcome
Change in weight loss after consumption of 1 Haas Avocado per day with a hypocaloric diet
Time frame: Baseline to 12 weeks
Individuals will be randomly assigned to a hypocaloric (500 Cal deficit) meal plans with or without one Hass avocado a day for 12 weeks.
1 secondary outcome
Change in gut microbiome
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 31367691Henning 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
UCLA Center for Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haas Avocado and Dietary Counseling in people with Overweight, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight loss after consumption of 1 Haas Avocado per day with a hypocaloric diet (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.