search
Back to results

The Lean Living Study

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walnut-rich weight loss diet
Standard weight loss diet
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring obesity, overweight, weight loss, satiety, walnuts, gastrointestinal peptides

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • willing to allow blood collections
  • no known allergy to tree nuts
  • capable of performing a simple test for assessing cardiopulmonary fitness

Exclusion Criteria:

  • 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

Sites / Locations

  • UC San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walnut-rich weight loss diet arm

Standard weight loss diet arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 9, 2015
Last Updated
October 24, 2017
Sponsor
University of California, San Diego
Collaborators
AICR Matching Grant Program (California Walnut Commission and AICR)
search

1. Study Identification

Unique Protocol Identification Number
NCT02501889
Brief Title
The Lean Living Study
Official Title
Walnut Consumption in a Weight Loss Intervention: Effects on Weight Change, Satiety and Potential Mediating Factors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
AICR Matching Grant Program (California Walnut Commission and AICR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
obesity, overweight, weight loss, satiety, walnuts, gastrointestinal peptides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walnut-rich weight loss diet arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard weight loss diet arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walnut-rich weight loss diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard weight loss diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Postprandial blood levels of satiety- and appetite-related gastrointestinal peptides (ghrelin, cholecystokinin, glucagon-like peptide, and peptide YY) following meals with or without walnuts in a sample subset, as an exploratory aim.
Time Frame
2 years
Title
Satiety- and appetite-related visual analogue scales following meals with or without walnuts in a sample subset, as an exploratory aim.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 willing to allow blood collections no known allergy to tree nuts capable of performing a simple test for assessing cardiopulmonary fitness Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl L. Rock, PhD, RD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25097630
Citation
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.
Results Reference
background
PubMed Identifier
12119580
Citation
Alper 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.
Results Reference
background
PubMed Identifier
25316904
Citation
Babio 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.
Results Reference
background
PubMed Identifier
19403639
Citation
Bes-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.
Results Reference
background
PubMed Identifier
16469977
Citation
Blom 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.
Results Reference
background
PubMed Identifier
19910942
Citation
Brennan 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.
Results Reference
background
PubMed Identifier
22556143
Citation
Brennan 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.
Results Reference
background
PubMed Identifier
19010571
Citation
Casas-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.
Results Reference
background
PubMed Identifier
20433660
Citation
Delzenne 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.
Results Reference
background
PubMed Identifier
18345020
Citation
Diepvens 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.
Results Reference
background
PubMed Identifier
22743313
Citation
Foster 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.
Results Reference
background
PubMed Identifier
23509106
Citation
Gibbons 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.
Results Reference
background
PubMed Identifier
25052364
Citation
Gibbons 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.
Results Reference
background
PubMed Identifier
20147463
Citation
Karhunen 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.
Results Reference
background
PubMed Identifier
11033986
Citation
Kirkmeyer 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.
Results Reference
background
PubMed Identifier
19629055
Citation
Leidy HJ, Apolzan JW, Mattes RD, Campbell WW. Food form and portion size affect postprandial appetite sensations and hormonal responses in healthy, nonobese, older adults. Obesity (Silver Spring). 2010 Feb;18(2):293-9. doi: 10.1038/oby.2009.217. Epub 2009 Jul 23.
Results Reference
background
PubMed Identifier
16400055
Citation
Lejeune MP, Westerterp KR, Adam TC, Luscombe-Marsh ND, Westerterp-Plantenga MS. Ghrelin and glucagon-like peptide 1 concentrations, 24-h satiety, and energy and substrate metabolism during a high-protein diet and measured in a respiration chamber. Am J Clin Nutr. 2006 Jan;83(1):89-94. doi: 10.1093/ajcn/83.1.89.
Results Reference
background
PubMed Identifier
20833992
Citation
Li Z, Song R, Nguyen C, Zerlin A, Karp H, Naowamondhol K, Thames G, Gao K, Li L, Tseng CH, Henning SM, Heber D. Pistachio nuts reduce triglycerides and body weight by comparison to refined carbohydrate snack in obese subjects on a 12-week weight loss program. J Am Coll Nutr. 2010 Jun;29(3):198-203. doi: 10.1080/07315724.2010.10719834.
Results Reference
background
PubMed Identifier
21172932
Citation
Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ros E, Covas MI, Fiol M, Warnberg J, Aros F, Ruiz-Gutierrez V, Lamuela-Raventos RM, Lapetra J, Munoz MA, Martinez JA, Saez G, Serra-Majem L, Pinto X, Mitjavila MT, Tur JA, Portillo MP, Estruch R; PREDIMED Study Investigators. Cohort profile: design and methods of the PREDIMED study. Int J Epidemiol. 2012 Apr;41(2):377-85. doi: 10.1093/ije/dyq250. Epub 2010 Dec 20. No abstract available.
Results Reference
background
PubMed Identifier
18716179
Citation
Mattes RD, Kris-Etherton PM, Foster GD. Impact of peanuts and tree nuts on body weight and healthy weight loss in adults. J Nutr. 2008 Sep;138(9):1741S-1745S. doi: 10.1093/jn/138.9.1741S.
Results Reference
background
PubMed Identifier
20199999
Citation
Mattes RD, Dreher ML. Nuts and healthy body weight maintenance mechanisms. Asia Pac J Clin Nutr. 2010;19(1):137-41.
Results Reference
background
PubMed Identifier
21696306
Citation
Mozaffarian D, Hao T, Rimm EB, Willett WC, Hu FB. Changes in diet and lifestyle and long-term weight gain in women and men. N Engl J Med. 2011 Jun 23;364(25):2392-404. doi: 10.1056/NEJMoa1014296.
Results Reference
background
PubMed Identifier
18042516
Citation
Natoli S, McCoy P. A review of the evidence: nuts and body weight. Asia Pac J Clin Nutr. 2007;16(4):588-97.
Results Reference
background
PubMed Identifier
14749224
Citation
Pelkman CL, Fishell VK, Maddox DH, Pearson TA, Mauger DT, Kris-Etherton PM. Effects of moderate-fat (from monounsaturated fat) and low-fat weight-loss diets on the serum lipid profile in overweight and obese men and women. Am J Clin Nutr. 2004 Feb;79(2):204-12. doi: 10.1093/ajcn/79.2.204.
Results Reference
background
PubMed Identifier
17125537
Citation
Rajaram S, Sabate J. Nuts, body weight and insulin resistance. Br J Nutr. 2006 Nov;96 Suppl 2:S79-86. doi: 10.1017/bjn20061867. Erratum In: Br J Nutr. 2008 Feb;99(2):447-8.
Results Reference
background
PubMed Identifier
16277792
Citation
Sabate J, Cordero-Macintyre Z, Siapco G, Torabian S, Haddad E. Does regular walnut consumption lead to weight gain? Br J Nutr. 2005 Nov;94(5):859-64. doi: 10.1079/bjn20051567.
Results Reference
background
PubMed Identifier
14574348
Citation
Wien MA, Sabate JM, Ikle DN, Cole SE, Kandeel FR. Almonds vs complex carbohydrates in a weight reduction program. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1365-72. doi: 10.1038/sj.ijo.0802411. Erratum In: Int J Obes Relat Metab Disord. 2004 Mar;28(3):459.
Results Reference
background
PubMed Identifier
29202751
Citation
Rock CL, Flatt SW, Barkai HS, Pakiz B, Heath DD. Walnut consumption in a weight reduction intervention: effects on body weight, biological measures, blood pressure and satiety. Nutr J. 2017 Dec 4;16(1):76. doi: 10.1186/s12937-017-0304-z.
Results Reference
derived

Learn more about this trial

The Lean Living Study

We'll reach out to this number within 24 hrs