ObesityNCT02347007
Impact of Almond Supplementation on Body Composition in Overweight/Obese Minority Adults
A study testing Almond and Cereal Bar in people with Obesity and Overweight, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Fatty Liver
- What is being tested?
- Almond and Cereal Bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2019
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetes
- Uncontrolled hypertension (high blood pressure)
- Cardiovascular disease
- Weight loss attempted in past 3 months
- Eating disorder
- Stroke, seizure disorder, or significant neurological disease
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Nutrition Obesity Research Center
New York, New York, 10032
About this study
Official title: Impact of Almond Supplementation, Relative to a Low-fat, High Carbohydrate Control, on Body Composition in Overweight and Obese Black and Hispanic Adults
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.
Read the detailed description
The study is a randomized, controlled study aimed at testing whether almonds, consumed within a free-living, self-selected diet, improve body composition and liver fat, relative to a low-fat/high-carbohydrate cereal bar (LF-HC) in overweight and obese Blacks and Hispanics. A secondary aim is to determine whether almond consumption will lead to an overall lower CVD risk profile.
Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily (2-3 oz) or a high-carbohydrate cereal bar (2 g of fat or less per 100 kcal) providing an equivalent amount of calories. 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 food supplement as a mid-afternoon snack and the rest at a meal of their choice.
At the baseline visit, participants will be given a 2-week supply of their allocated food supplement and will obtain additional supplies at bi-weekly visits for the first 8 weeks. After the week 8 visit, participants will be given monthly rations of their food supplement, either almonds or LF-HC cereal bar, and will be asked to come to research center every 4 weeks to obtain their next supply. At those visits, body weight and blood pressure will be measured and participants will turn in weekly dietary diaries, reporting their supplement intake. Participants will also receive one random phone call every 4 weeks to provide a 24-h recall. This recall will be used as an index of dietary quality but also as a compliance check with dietary supplements. In addition, 3-day food records will be collected prior to the start of the study and during the final week to assess any dietary changes due to the intervention. A food frequency questionnaire will also be administered at screening and endpoint of the study. This food-frequency questionnaire will target nut consumption.
At the end of the study, intention to continue eating almonds or a low-fat diet will be assessed using questions adapted from de Bruijn et al. Participants in the almond group will be asked the following questions: (1) "I intend to include almonds in my diet" (+2 = yes, definitely; -2 = no, definitely); (2) "How certain are you that you will include almonds in your diet?" (+2 = very certain; -2 = very uncertain); (3) "Including almonds in my diet is" (instrumental attitude: +3 = healthy; -3 = unhealthy; affective attitude: +3 = pleasant; -3 = unpleasant); (4) "I find including almonds in my diet" (perceived behavioral control: +3 = easy; -3 = difficult). Corresponding questions for the control group will replace "include almonds" with "reduce the amount of fat". Participants will be called 4 weeks later to obtain information on their actual almond and fat intakes by questionnaire and 24-h recall.
- Conditions
- Obesity, Overweight, Fatty Liver, Metabolic Syndrome X
- Being tested
- Almond, Cereal Bar
- Keywords
- Obesity, Overweight, Body Weight, Cardiovascular Diseases, Cholesterol, Almonds, Visceral Adiposity, Quality of Life, Hispanic Americans, African Continental Ancestry Group, Metabolic Syndrome X
- Medical subject headings
- Obesity, Overweight, Fatty Liver, Metabolic Syndrome, Body Weight, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondDietary 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.
Cereal BarDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Almond | Experimental | Not described Receives: Dietary Supplement: Almond |
| Cereal Bar | Active comparator | Not described Receives: Dietary Supplement: Cereal Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body Composition
MRI will be used to provide information on total adipose tissue and all adipose tissue sub-compartments: visceral, subcutaneous, intermuscular.
Measured: Baseline and endpoint visits (Weeks 0 and 24)
Change in liver Fat
MRS will be used to provide information on liver adiposity.
Measured: Baseline and endpoint visits (weeks 0 and 24)
Secondary outcomes (3)
Change in cardio-metabolic risk profile
Blood draw and analyses will be used to measure total and low-density lipoprotein cholesterol, triglycerides, high-density lipoprotein cholesterol, glucose, insulin, and inflammatory markers.
Measured: Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Change in brain-derived neutrophic factor (BDNF)
Blood draw and analyses will be used measure BDNF.
Measured: Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Change in quality of life
SF-36 questionnaire will be used to assess quality of life.
Measured: Baseline and endpoint visits (weeks 0 and 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre St-Onge, Ph.D., Principal investigator, College of Physicians & Surgeons, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347007
- Sponsor's protocol ID
- AAAN4353
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Almond Supplementation, Relative to a Low-fat, High Carbohydrate Control, on Body Composition in Overweight and Obese Black and Hispanic Adults
- ClinicalTrials.gov ID
- NCT02347007
- Acronym / sponsor ID
- AAAN4353
- Conditions
- Obesity, Overweight, Fatty Liver, Metabolic Syndrome X
- Keywords
- Obesity, Overweight, Body Weight, Cardiovascular Diseases, Cholesterol, Almonds, Visceral Adiposity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 27 Jan 2015 (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.
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.
Detailed description
The study is a randomized, controlled study aimed at testing whether almonds, consumed within a free-living, self-selected diet, improve body composition and liver fat, relative to a low-fat/high-carbohydrate cereal bar (LF-HC) in overweight and obese Blacks and Hispanics. A secondary aim is to determine whether almond consumption will lead to an overall lower CVD risk profile.
Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily (2-3 oz) or a high-carbohydrate cereal bar (2 g of fat or less per 100 kcal) providing an equivalent amount of calories. 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 food supplement as a mid-afternoon snack and the rest at a meal of their choice.
At the baseline visit, participants will be given a 2-week supply of their allocated food supplement and will obtain additional supplies at bi-weekly visits for the first 8 weeks. After the week 8 visit, participants will be given monthly rations of their food supplement, either almonds or LF-HC cereal bar, and will be asked to come to research center every 4 weeks to obtain their next supply. At those visits, body weight and blood pressure will be measured and participants will turn in weekly dietary diaries, reporting their supplement intake. Participants will also receive one random phone call every 4 weeks to provide a 24-h recall. This recall will be used as an index of dietary quality but also as a compliance check with dietary supplements. In addition, 3-day food records will be collected prior to the start of the study and during the final week to assess any dietary changes due to the intervention. A food frequency questionnaire will also be administered at screening and endpoint of the study. This food-frequency questionnaire will target nut consumption.
At the end of the study, intention to continue eating almonds or a low-fat diet will be assessed using questions adapted from de Bruijn et al. Participants in the almond group will be asked the following questions: (1) "I intend to include almonds in my diet" (+2 = yes, definitely; -2 = no, definitely); (2) "How certain are you that you will include almonds in your diet?" (+2 = very certain; -2 = very uncertain); (3) "Including almonds in my diet is" (instrumental attitude: +3 = healthy; -3 = unhealthy; affective attitude: +3 = pleasant; -3 = unpleasant); (4) "I find including almonds in my diet" (perceived behavioral control: +3 = easy; -3 = difficult). Corresponding questions for the control group will replace "include almonds" with "reduce the amount of fat". Participants will be called 4 weeks later to obtain information on their actual almond and fat intakes by questionnaire and 24-h recall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond | Experimental | Dietary Supplement: Almond |
| Cereal Bar | Active comparator | Dietary Supplement: Cereal Bar |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- Diabetes
- Uncontrolled hypertension (high blood pressure)
- Cardiovascular disease
- Weight loss attempted in past 3 months
- Eating disorder
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 |
|---|---|---|
| AlmondParticipants 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. | Dietary supplement | Almond |
| Cereal BarParticipants 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. | Dietary supplement | Cereal Bar |
Primary outcome
Change in body Composition
Time frame: Baseline and endpoint visits (Weeks 0 and 24)
MRI will be used to provide information on total adipose tissue and all adipose tissue sub-compartments: visceral, subcutaneous, intermuscular.
Change in liver Fat
Time frame: Baseline and endpoint visits (weeks 0 and 24)
MRS will be used to provide information on liver adiposity.
3 secondary outcomes
Change in cardio-metabolic risk profile
Time frame: Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Change in brain-derived neutrophic factor (BDNF)
Time frame: Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24)
Change in quality of life
Time frame: Baseline and endpoint visits (weeks 0 and 24)
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 13 Jan 2020.
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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.
Marie-Pierre St-Onge, Ph.D. principal investigator
College of Physicians & Surgeons, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond and Cereal Bar in people with Obesity and Overweight, run by Columbia University 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 6 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 13 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 body Composition (time frame: Baseline and endpoint visits (Weeks 0 and 24)). The study lists 2 primary outcomes in all. 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 13 Jan 2020.