Overweight and ObesityNCT02501889
The Lean Living Study
A study testing Walnut-rich weight loss diet and Standard weight loss diet in people with Overweight and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
This study investigates whether walnuts help to promote weight loss, associated with increased meal satiety and satisfaction, in 100 overweight and obese men and women who are participating in a 6-month behavioral weight loss intervention. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Walnut-rich weight loss diet and Standard weight loss diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 21 years and older
- BMI >27.0 kg/m2 and <40 kg/m2
- non-smoker
- willing and able to participate in clinic visits, group sessions, telephone, and internet communications at specified intervals
- able to provide data through questionnaires and by telephone
- willing to maintain contact with the investigators for 6 months
Show all 9Show fewer
- willing to allow blood collections
- no known allergy to tree nuts
- capable of performing a simple test for assessing cardiopulmonary fitness
Who cannot join
- inability to participate in physical activity because of severe disability
- a history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
- smoker
- self-reported pregnancy or breastfeeding or planning a pregnancy within the next year
- currently actively involved in another diet intervention study or organized weight loss program
- a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgement, would interfere with participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Walnut Consumption in a Weight Loss Intervention: Effects on Weight Change, Satiety and Potential Mediating Factors
This study investigates whether walnuts help to promote weight loss, associated with increased meal satiety and satisfaction, in 100 overweight and obese men and women who are participating in a 6-month behavioral weight loss intervention. Participants will be randomly assigned to a walnut-enriched reduced-calorie diet or a standard reduced-calorie diet. Body weight, risk factors for cardiovascular disease, and self-reported feelings relevant to satiety and appetite will be measured at baseline and 3- and 6-month follow-up. Also, the response of gastrointestinal tract hormones following meals with or without walnuts will be measured in a subset of study participants (n=20). Results from this study will contribute to understanding the role of nuts in weight control, including further knowledge of the mechanisms, and will expand knowledge of how nuts in the diet may contribute to the prevention and management of obesity.
Read the detailed description
Epidemiological studies have linked regular consumption of nuts with lower body mass index and reduced likelihood of weight gain in adulthood. Several mechanisms have been proposed to explain why nuts may facilitate weight management, including their high satiety property which may promote dietary compensation with reduced subsequent energy intake. Although proposed as a possible mediating factor, satiety and satiation in relation to nuts or nut-containing meals have been examined in only a few previous studies. The effects of nut consumption in the context of a weight loss intervention have been examined in only five previously-published randomized studies, which have tested the effects of almonds, pistachios or peanuts (but not walnuts) and have had mixed results.
This project is a study to investigate the effects of a walnut-enriched vs. standard reduced-energy diet on body weight and satiety via pre- and post-meal ratings scales, as well as exploring the response of satiety- and appetite-related gastrointestinal peptides to meals with or without walnuts in a sample subset.
The specific aims of this study are:
- To compare the effects of a walnut-enriched reduced-energy diet to a standard reduced-energy diet on body weight and cardiovascular disease risk factors in a sample of overweight and obese adults in an intensive 6-month weight loss intervention.
- To examine whether there is a differential response in satiety- and appetite-related ratings scales in association with a walnut-enriched reduced-energy diet and a standard reduced-energy diet among the participants in this weight-loss study.
- To examine the response of satiety- and appetite-related gastrointestinal peptides (ghrelin, cholecystokinin, glucagon-like peptide, and peptide YY), to meals with or without walnuts in a sample subset, as an exploratory aim.
The first two aims will be addressed in a randomized controlled study involving 100 overweight or obese men and women assigned to a walnut-enriched reduced-energy diet or a standard reduced-energy diet in the context of a 6-month intensive weight loss intervention. Subjective satiety- and appetite-related ratings will be collected at specific intervals before lunch and dinner using visual analogue scales. Postprandial gastrointestinal peptide response to a meal with or without walnuts, the third and exploratory aim, will be measured in a subset of study participants (n=20) using a within-subject crossover study design.
The investigators hypothesize that participants assigned to the walnut-enriched diet study arm will have greater weight loss and overall better improvements in cardiovascular disease risk factors, and that ratings of hunger, fullness, and anticipated prospective consumption will differ from those of participants assigned to the standard reduced-energy diet. The investigators hypothesize that postprandial satiety- and appetite-related gastrointestinal peptides, which play a role in short-term control of appetite and may be biomarkers of satiety, may differ in response to different isocaloric meal composition. Results from this study will contribute to understanding the role of nuts in weight control, including further knowledge of the explanatory mechanisms, and will expand knowledge of how nuts in the diet may contribute to the prevention and management of obesity.
- Conditions
- Overweight and Obesity
- Being tested
- Walnut-rich weight loss diet, Standard weight loss diet
- Keywords
- obesity, overweight, weight loss, satiety, walnuts, gastrointestinal peptides
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut-rich weight loss dietBehavioural
Composition of prescribed diets will be based on individual preferences, with the goal of reduced energy intake and increased energy expenditure. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Walnuts will be provided to participants. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.
Standard weight loss dietBehavioural
Composition of prescribed diets will be based on individual preferences, with the goal of reduced energy intake and increased energy expenditure. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.
| Study group | Role | What they receive |
|---|---|---|
| Walnut-rich weight loss diet arm | Experimental | Participants will have an individualized reduced-calorie diet prescription and weight loss counseling session with the project coordinator, who is a registered dietitian. Composition of prescribed diets will be based on individual preferences. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. All participants will have contact with the project coordinator a minimum of every 1-2 weeks. Walnuts will be provided to participants in the walnut-rich study arm. Receives: Behavioral: Walnut-rich weight loss diet |
| Standard weight loss diet arm | Active comparator | Participants will have an individualized reduced-calorie diet prescription and weight loss counseling session with the project coordinator, who is a registered dietitian. Composition of prescribed diets will be based on individual preferences. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Participants assigned to this arm will be instructed to abstain from the consumption of nuts during the study. All participants will have contact with the project coordinator a minimum of every 1-2 weeks. Receives: Behavioral: Standard weight loss diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight in response to being assigned a walnut-enriched reduced-energy diet or a standard reduced-energy diet in an intensive 6-month weight loss intervention.
Measured: 2 years
Change in cardiovascular disease risk factors in response to being assigned a walnut-enriched reduced-energy diet or a standard reduced-energy diet in an intensive 6-month weight loss intervention.
Measured: 2 years
Secondary outcomes (1)
Satiety- and appetite-related visual analogue scales in response to being prescribed a walnut- enriched reduced-energy diet or a standard reduced-energy diet among the participants in the weight-loss intervention.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- AICR Matching Grant Program (California Walnut Commission and AICR)
- Responsible party
- Principal investigator, Cheryl Rock, University of California, San Diego
- Investigators
- Cheryl L. Rock, PhD, RD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501889
- Sponsor's protocol ID
- 20154971
- Status last verified
- Sep 2016
- First submitted
- 9 Jul 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Abazarfard Z, Salehi M, Keshavarzi S. The effect of almonds on anthropometric measurements and lipid profile in overweight and obese females in a weight reduction program: A randomized controlled clinical trial. J Res Med Sci. 2014 May;19(5):457-64.
PubMed 25097630Alper CM, Mattes RD. Effects of chronic peanut consumption on energy balance and hedonics. Int J Obes Relat Metab Disord. 2002 Aug;26(8):1129-37. doi: 10.1038/sj.ijo.0802050.
PubMed 12119580Babio N, Toledo E, Estruch R, Ros E, Martinez-Gonzalez MA, Castaner O, Bullo M, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Sorli JV, Salas-Salvado J; PREDIMED Study Investigators. Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial. CMAJ. 2014 Nov 18;186(17):E649-57. doi: 10.1503/cmaj.140764. Epub 2014 Oct 14.
PubMed 25316904Bes-Rastrollo M, Wedick NM, Martinez-Gonzalez MA, Li TY, Sampson L, Hu FB. Prospective study of nut consumption, long-term weight change, and obesity risk in women. Am J Clin Nutr. 2009 Jun;89(6):1913-9. doi: 10.3945/ajcn.2008.27276. Epub 2009 Apr 29.
PubMed 19403639Blom WA, Lluch A, Stafleu A, Vinoy S, Holst JJ, Schaafsma G, Hendriks HF. Effect of a high-protein breakfast on the postprandial ghrelin response. Am J Clin Nutr. 2006 Feb;83(2):211-20. doi: 10.1093/ajcn/83.2.211.
PubMed 16469977Brennan AM, Sweeney LL, Liu X, Mantzoros CS. Walnut consumption increases satiation but has no effect on insulin resistance or the metabolic profile over a 4-day period. Obesity (Silver Spring). 2010 Jun;18(6):1176-82. doi: 10.1038/oby.2009.409. Epub 2009 Nov 12.
PubMed 19910942Brennan IM, Luscombe-Marsh ND, Seimon RV, Otto B, Horowitz M, Wishart JM, Feinle-Bisset C. Effects of fat, protein, and carbohydrate and protein load on appetite, plasma cholecystokinin, peptide YY, and ghrelin, and energy intake in lean and obese men. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G129-40. doi: 10.1152/ajpgi.00478.2011. Epub 2012 May 3.
PubMed 22556143Casas-Agustench P, Lopez-Uriarte P, Bullo M, Ros E, Gomez-Flores A, Salas-Salvado J. Acute effects of three high-fat meals with different fat saturations on energy expenditure, substrate oxidation and satiety. Clin Nutr. 2009 Feb;28(1):39-45. doi: 10.1016/j.clnu.2008.10.008. Epub 2008 Nov 17.
PubMed 19010571Delzenne N, Blundell J, Brouns F, Cunningham K, De Graaf K, Erkner A, Lluch A, Mars M, Peters HP, Westerterp-Plantenga M. Gastrointestinal targets of appetite regulation in humans. Obes Rev. 2010 Mar;11(3):234-50. doi: 10.1111/j.1467-789X.2009.00707.x.
PubMed 20433660Diepvens K, Haberer D, Westerterp-Plantenga M. Different proteins and biopeptides differently affect satiety and anorexigenic/orexigenic hormones in healthy humans. Int J Obes (Lond). 2008 Mar;32(3):510-8. doi: 10.1038/sj.ijo.0803758. Epub 2007 Nov 27.
PubMed 18345020Foster GD, Shantz KL, Vander Veur SS, Oliver TL, Lent MR, Virus A, Szapary PO, Rader DJ, Zemel BS, Gilden-Tsai A. A randomized trial of the effects of an almond-enriched, hypocaloric diet in the treatment of obesity. Am J Clin Nutr. 2012 Aug;96(2):249-54. doi: 10.3945/ajcn.112.037895. Epub 2012 Jun 27.
PubMed 22743313Gibbons C, Caudwell P, Finlayson G, Webb DL, Hellstrom PM, Naslund E, Blundell JE. Comparison of postprandial profiles of ghrelin, active GLP-1, and total PYY to meals varying in fat and carbohydrate and their association with hunger and the phases of satiety. J Clin Endocrinol Metab. 2013 May;98(5):E847-55. doi: 10.1210/jc.2012-3835. Epub 2013 Mar 18.
PubMed 23509106Gibbons C, Finlayson G, Dalton M, Caudwell P, Blundell JE. Metabolic Phenotyping Guidelines: studying eating behaviour in humans. J Endocrinol. 2014 Aug;222(2):G1-12. doi: 10.1530/JOE-14-0020.
PubMed 25052364Karhunen LJ, Juvonen KR, Flander SM, Liukkonen KH, Lahteenmaki L, Siloaho M, Laaksonen DE, Herzig KH, Uusitupa MI, Poutanen KS. A psyllium fiber-enriched meal strongly attenuates postprandial gastrointestinal peptide release in healthy young adults. J Nutr. 2010 Apr;140(4):737-44. doi: 10.3945/jn.109.115436. Epub 2010 Feb 10.
PubMed 20147463Kirkmeyer SV, Mattes RD. Effects of food attributes on hunger and food intake. Int J Obes Relat Metab Disord. 2000 Sep;24(9):1167-75. doi: 10.1038/sj.ijo.0801360.
PubMed 11033986
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walnut Consumption in a Weight Loss Intervention: Effects on Weight Change, Satiety and Potential Mediating Factors
- ClinicalTrials.gov ID
- NCT02501889
- Acronym / sponsor ID
- 20154971
- Conditions
- Overweight and Obesity
- Keywords
- obesity, overweight, weight loss, satiety, walnuts, gastrointestinal peptides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- AICR Matching Grant Program (California Walnut Commission and AICR)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Jul 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.
This study investigates whether walnuts help to promote weight loss, associated with increased meal satiety and satisfaction, in 100 overweight and obese men and women who are participating in a 6-month behavioral weight loss intervention. Participants will be randomly assigned to a walnut-enriched reduced-calorie diet or a standard reduced-calorie diet. Body weight, risk factors for cardiovascular disease, and self-reported feelings relevant to satiety and appetite will be measured at baseline and 3- and 6-month follow-up. Also, the response of gastrointestinal tract hormones following meals with or without walnuts will be measured in a subset of study participants (n=20). Results from this study will contribute to understanding the role of nuts in weight control, including further knowledge of the mechanisms, and will expand knowledge of how nuts in the diet may contribute to the prevention and management of obesity.
Detailed description
Epidemiological studies have linked regular consumption of nuts with lower body mass index and reduced likelihood of weight gain in adulthood. Several mechanisms have been proposed to explain why nuts may facilitate weight management, including their high satiety property which may promote dietary compensation with reduced subsequent energy intake. Although proposed as a possible mediating factor, satiety and satiation in relation to nuts or nut-containing meals have been examined in only a few previous studies. The effects of nut consumption in the context of a weight loss intervention have been examined in only five previously-published randomized studies, which have tested the effects of almonds, pistachios or peanuts (but not walnuts) and have had mixed results.
This project is a study to investigate the effects of a walnut-enriched vs. standard reduced-energy diet on body weight and satiety via pre- and post-meal ratings scales, as well as exploring the response of satiety- and appetite-related gastrointestinal peptides to meals with or without walnuts in a sample subset.
The specific aims of this study are:
- To compare the effects of a walnut-enriched reduced-energy diet to a standard reduced-energy diet on body weight and cardiovascular disease risk factors in a sample of overweight and obese adults in an intensive 6-month weight loss intervention.
- To examine whether there is a differential response in satiety- and appetite-related ratings scales in association with a walnut-enriched reduced-energy diet and a standard reduced-energy diet among the participants in this weight-loss study.
- To examine the response of satiety- and appetite-related gastrointestinal peptides (ghrelin, cholecystokinin, glucagon-like peptide, and peptide YY), to meals with or without walnuts in a sample subset, as an exploratory aim.
The first two aims will be addressed in a randomized controlled study involving 100 overweight or obese men and women assigned to a walnut-enriched reduced-energy diet or a standard reduced-energy diet in the context of a 6-month intensive weight loss intervention. Subjective satiety- and appetite-related ratings will be collected at specific intervals before lunch and dinner using visual analogue scales. Postprandial gastrointestinal peptide response to a meal with or without walnuts, the third and exploratory aim, will be measured in a subset of study participants (n=20) using a within-subject crossover study design.
The investigators hypothesize that participants assigned to the walnut-enriched diet study arm will have greater weight loss and overall better improvements in cardiovascular disease risk factors, and that ratings of hunger, fullness, and anticipated prospective consumption will differ from those of participants assigned to the standard reduced-energy diet. The investigators hypothesize that postprandial satiety- and appetite-related gastrointestinal peptides, which play a role in short-term control of appetite and may be biomarkers of satiety, may differ in response to different isocaloric meal composition. Results from this study will contribute to understanding the role of nuts in weight control, including further knowledge of the explanatory mechanisms, and will expand knowledge of how nuts in the diet may contribute to the prevention and management of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut-rich weight loss diet arm | Experimental | Behavioral: Walnut-rich weight loss dietParticipants will have an individualized reduced-calorie diet prescription and weight loss counseling session with the project coordinator, who is a registered dietitian. Composition of prescribed diets will be based on individual preferences. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. All participants will have contact with the project coordinator a minimum of every 1-2 weeks. Walnuts will be provided to participants in the walnut-rich study arm. |
| Standard weight loss diet arm | Active comparator | Behavioral: Standard weight loss dietParticipants will have an individualized reduced-calorie diet prescription and weight loss counseling session with the project coordinator, who is a registered dietitian. Composition of prescribed diets will be based on individual preferences. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Participants assigned to this arm will be instructed to abstain from the consumption of nuts during the study. All participants will have contact with the project coordinator a minimum of every 1-2 weeks. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged 21 years and older
- BMI >27.0 kg/m2 and <40 kg/m2
- non-smoker
- willing and able to participate in clinic visits, group sessions, telephone, and internet communications at specified intervals
- able to provide data through questionnaires and by telephone
Key exclusion criteria (6 listed)
- inability to participate in physical activity because of severe disability
- a history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
- smoker
- self-reported pregnancy or breastfeeding or planning a pregnancy within the next year
- currently actively involved in another diet intervention study or organized weight loss program
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 |
|---|---|---|
| Walnut-rich weight loss dietComposition of prescribed diets will be based on individual preferences, with the goal of reduced energy intake and increased energy expenditure. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Walnuts will be provided to participants. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training. | Behavioural | Walnut-rich weight loss diet arm |
| Standard weight loss dietComposition of prescribed diets will be based on individual preferences, with the goal of reduced energy intake and increased energy expenditure. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training. | Behavioural | Standard weight loss diet arm |
Primary outcome
Change in body weight in response to being assigned a walnut-enriched reduced-energy diet or a standard reduced-energy diet in an intensive 6-month weight loss intervention.
Time frame: 2 years
Change in cardiovascular disease risk factors in response to being assigned a walnut-enriched reduced-energy diet or a standard reduced-energy diet in an intensive 6-month weight loss intervention.
Time frame: 2 years
1 secondary outcome
Satiety- and appetite-related visual analogue scales in response to being prescribed a walnut- enriched reduced-energy diet or a standard reduced-energy diet among the participants in the weight-loss intervention.
Time frame: 2 years
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 26 Oct 2017.
- Background: PubMed 25097630Abazarfard Z, Salehi M, Keshavarzi S. The effect of almonds on anthropometric measurements and lipid profile in overweight and obese females in a weight reduction program: A randomized controlled clinical trial. J Res Med Sci. 2014 May;19(5):457-64.
- Background: PubMed 12119580Alper CM, Mattes RD. Effects of chronic peanut consumption on energy balance and hedonics. Int J Obes Relat Metab Disord. 2002 Aug;26(8):1129-37. doi: 10.1038/sj.ijo.0802050.
- Background: PubMed 25316904Babio N, Toledo E, Estruch R, Ros E, Martinez-Gonzalez MA, Castaner O, Bullo M, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Sorli JV, Salas-Salvado J; PREDIMED Study Investigators. Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial. CMAJ. 2014 Nov 18;186(17):E649-57. doi: 10.1503/cmaj.140764. Epub 2014 Oct 14.
- Background: PubMed 19403639Bes-Rastrollo M, Wedick NM, Martinez-Gonzalez MA, Li TY, Sampson L, Hu FB. Prospective study of nut consumption, long-term weight change, and obesity risk in women. Am J Clin Nutr. 2009 Jun;89(6):1913-9. doi: 10.3945/ajcn.2008.27276. Epub 2009 Apr 29.
- Background: PubMed 16469977Blom WA, Lluch A, Stafleu A, Vinoy S, Holst JJ, Schaafsma G, Hendriks HF. Effect of a high-protein breakfast on the postprandial ghrelin response. Am J Clin Nutr. 2006 Feb;83(2):211-20. doi: 10.1093/ajcn/83.2.211.
- Background: PubMed 19910942Brennan AM, Sweeney LL, Liu X, Mantzoros CS. Walnut consumption increases satiation but has no effect on insulin resistance or the metabolic profile over a 4-day period. Obesity (Silver Spring). 2010 Jun;18(6):1176-82. doi: 10.1038/oby.2009.409. Epub 2009 Nov 12.
- Background: PubMed 22556143Brennan IM, Luscombe-Marsh ND, Seimon RV, Otto B, Horowitz M, Wishart JM, Feinle-Bisset C. Effects of fat, protein, and carbohydrate and protein load on appetite, plasma cholecystokinin, peptide YY, and ghrelin, and energy intake in lean and obese men. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G129-40. doi: 10.1152/ajpgi.00478.2011. Epub 2012 May 3.
- Background: PubMed 19010571Casas-Agustench P, Lopez-Uriarte P, Bullo M, Ros E, Gomez-Flores A, Salas-Salvado J. Acute effects of three high-fat meals with different fat saturations on energy expenditure, substrate oxidation and satiety. Clin Nutr. 2009 Feb;28(1):39-45. doi: 10.1016/j.clnu.2008.10.008. Epub 2008 Nov 17.
- Background: PubMed 20433660Delzenne N, Blundell J, Brouns F, Cunningham K, De Graaf K, Erkner A, Lluch A, Mars M, Peters HP, Westerterp-Plantenga M. Gastrointestinal targets of appetite regulation in humans. Obes Rev. 2010 Mar;11(3):234-50. doi: 10.1111/j.1467-789X.2009.00707.x.
- Background: PubMed 18345020Diepvens K, Haberer D, Westerterp-Plantenga M. Different proteins and biopeptides differently affect satiety and anorexigenic/orexigenic hormones in healthy humans. Int J Obes (Lond). 2008 Mar;32(3):510-8. doi: 10.1038/sj.ijo.0803758. Epub 2007 Nov 27.
- Background: PubMed 22743313Foster GD, Shantz KL, Vander Veur SS, Oliver TL, Lent MR, Virus A, Szapary PO, Rader DJ, Zemel BS, Gilden-Tsai A. A randomized trial of the effects of an almond-enriched, hypocaloric diet in the treatment of obesity. Am J Clin Nutr. 2012 Aug;96(2):249-54. doi: 10.3945/ajcn.112.037895. Epub 2012 Jun 27.
- Background: PubMed 23509106Gibbons C, Caudwell P, Finlayson G, Webb DL, Hellstrom PM, Naslund E, Blundell JE. Comparison of postprandial profiles of ghrelin, active GLP-1, and total PYY to meals varying in fat and carbohydrate and their association with hunger and the phases of satiety. J Clin Endocrinol Metab. 2013 May;98(5):E847-55. doi: 10.1210/jc.2012-3835. Epub 2013 Mar 18.
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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.
Cheryl L. Rock, PhD, RD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut-rich weight loss diet and Standard weight loss diet in people with Overweight and Obesity, run by University of California, San Diego 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 9 inclusion and 6 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 26 Oct 2017. 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 in response to being assigned a walnut-enriched reduced-energy diet or a standard reduced-energy diet in an intensive 6-month weight loss intervention. (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT02501889, which also lists 28 linked publications.
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 26 Oct 2017.