OverweightNCT03159689
The Effect of a Healthy Snack on Body Weight and Composition
A study testing Mixed Tree Nuts and Pretzels in people with Overweight, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The results from this study may help to explain if incorporating mixed nuts in a reduced calorie diet will lead to weight loss. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Mixed Tree Nuts and Pretzels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Dec 2020
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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.
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187
Los Angeles, California, 90095
About this study
Official title: Mixed Nuts as Healthy Snack: Effect on Body Weight and Composition
The results from this study may help to explain if incorporating mixed nuts in a reduced calorie diet will lead to weight loss.
Read the detailed description
This study will compare two energy reduced diets; one diet will include one serving of mixed nuts (1.5oz) per day, while the other diet will include an equal amount of calories from a carbohydrate source, such as a pretzel snack. All subjects will receive a dietary plan that reduces their usual intake by 500kcal/day with the same percentage of fat, protein and carbohydrates for the first 12 weeks followed a diet with their usual intake for 12 weeks without nuts or pretzels.
- Conditions
- Overweight
- Being tested
- Mixed Tree Nuts, Pretzels
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Tree NutsOther
Individuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz mixed tree nuts
PretzelsOther
Individuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz pretzels
| Study group | Role | What they receive |
|---|---|---|
| Mixed Tree Nuts | Experimental | a hypo caloric weight loss dietary plan with mixed tree nuts Receives: Other: Mixed Tree Nuts |
| Pretzels | Active comparator | a hypo caloric weight loss dietary plan with pretzels Receives: Other: Pretzels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Weight loss as determined by body composition and body mass index
Measured: baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Feb 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159689
- Sponsor's protocol ID
- 17-000361
- Status last verified
- Apr 2021
- First submitted
- 17 May 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Nuts as Healthy Snack: Effect on Body Weight and Composition
- ClinicalTrials.gov ID
- NCT03159689
- Acronym / sponsor ID
- 17-000361
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 19 May 2017 (actual)
- 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.
The results from this study may help to explain if incorporating mixed nuts in a reduced calorie diet will lead to weight loss.
Detailed description
This study will compare two energy reduced diets; one diet will include one serving of mixed nuts (1.5oz) per day, while the other diet will include an equal amount of calories from a carbohydrate source, such as a pretzel snack. All subjects will receive a dietary plan that reduces their usual intake by 500kcal/day with the same percentage of fat, protein and carbohydrates for the first 12 weeks followed a diet with their usual intake for 12 weeks without nuts or pretzels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Mixed Tree Nuts | Experimental | Other: Mixed Tree Nutsa hypo caloric weight loss dietary plan with mixed tree nuts |
| Pretzels | Active comparator | Other: Pretzelsa hypo caloric weight loss dietary plan with pretzels |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 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.
- 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)
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 |
|---|---|---|
| Mixed Tree NutsIndividuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz mixed tree nuts | Other | Mixed Tree Nuts |
| PretzelsIndividuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz pretzels | Other | Pretzels |
Primary outcome
Change in body weight
Time frame: baseline to Week 24
Weight loss as determined by body composition and body mass index
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 19 Apr 2021.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Tree Nuts and Pretzels 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 8 inclusion and 15 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 19 Apr 2021. 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 body weight (time frame: baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2021.