A Trial of the Ideal Protein System Versus Low Fat Diet for Weight Loss

Weight Loss Clinical Trial

— RENEWAL  

Official title:

A Trial of the Ideal Protein System Versus Low Fat Diet for Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515889
• Other study ID #: 2017-917
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine whether, compared to a standard, low-fat, calorie-restricted diet intervention, the clinic-supported Ideal Protein weight loss method will result in greater weight loss and improvement in cardiometabolic risk factors over 3 months among obese adults with cardiovascular disease (CVD) risk factors.

Description:

Restricting total calorie intake is emphasized in the 2013 American Heart Association/ American College of Cardiology/ The Obesity Society Guideline (AHA/ACC/TOS) for the Management of Overweight and Obesity in Adults for its effectiveness at reducing body weight and decreasing cardiometabolic risk factors. An implication of this focus on total quantity of calories consumed is that macronutrient composition of dietary intake and its effects on the hormonal milieu that regulates adipose accumulation in the human body do not play a significant role in weight loss. Such recommendations and the results of limited previous studies have led to the advice that all weight loss diets regardless of macronutrient composition will produce the same degree of weight loss if adherence to the diet is similar. In contrast, our previous studies have shown that despite comparable adherence to dietary goals, participants losing weight on a moderately carbohydrate-restricted, adequate protein regimen have improved cardiometabolic indicators as compared to those restricting fat. The RENEWAL trial will provide unique data on the efficacy of the Ideal Protein method (moderate carbohydrate restriction and adequate protein) for weight loss and improvement in cardiometabolic risk factors. The interventions will include a significant proportion of African-Americans, a group with very high rates of obesity which is often under-represented in trials examining the effects of weight loss diets. Findings from this trial may offer new evidence for the recommendation of specific macronutrient and behavioral approaches to the reduction of cardiometabolic risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 79 Years

Eligibility

Inclusion Criteria:

1. All participants will be obese. Obesity will be defined as BMI = 30 kg/m2 at the baseline study visit. An upper limit of BMI will be set at 49 kg/m2 to include a wide range of obese men and women with a reasonable probability of losing weight in the context of a dietary behavioral intervention.

2. Participants must have at least one co-morbid condition that increases risk of cardiovascular disease (history of CVD, type II diabetes mellitus, fasting plasma glucose>100 mg/dL, metabolic syndrome as defined by ATP III criteria, hypertension, hyperlipidemia, WC>40 in among men or >35 in among women).

3. All potential participants must be willing and able to provide informed consent.

Exclusion Criteria:

1. History of any bariatric surgery, including gastric banding, Roux-en-Y and duodenal switch with biliopancreatic diversion procedures, vertical banded gastroplasty, etc.

2. Currently on a diet or using prescription weight loss medications, and/or experienced weight loss >15 pounds within 6 months of study entry.

3. Regular use of alcohol >3 beverages per day or 21 beverages per week (1 standard beverage = 350 mL of 5% alcohol beer, or 150 mL of 12% wine, or 45 mL of 80-proof distilled spirits), amphetamines, cocaine, heroin, or marijuana over past 6 months.

4. Past or present history of eating disorder (including anorexia, bulimia or binge eating disorder) or severe/untreated psychiatric illness which may affect participation in study interventions.

5. Strict dietary concerns (e.g., vegetarian or kosher diet, significant nut or multiple food allergies). This is an exclusion because participant may not be able to fully participate in the intervention.

6. For women, current pregnancy or breastfeeding or plans to become pregnant during the study period. This is an exclusion because weight loss is contraindicated during pregnancy.

7. Plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site. This is an exclusion because these conditions may interfere with the ability to fully participate in and complete the study.

8. Participation of another household member in the study; employees or persons living with employees of the study. This is an exclusion because randomization of more than one participant in a household to differing diets may cause conflict within a household and limit engagement in the intervention. Employees of the study are excluded due to potential conflicts of interest and knowledge of study assignments.

9. Participation in other lifestyle intervention trials currently. This is an exclusion because interference with ability to determine whether study interventions are responsible for outcomes.

10. Medical condition in which a carbohydrate restricted diet may not be advised (eg. severe renal impairment, osteoporosis, untreated thyroid disease, frequent gout attacks, Type I diabetes). This is an exclusion because participant may not be able to fully participate in the intervention.

11. Hospitalization for a CVD event such as myocardial infarction, stroke, TIA, coronary revascularization, heart failure, peripheral artery disease, or unstable angina within the last 6 weeks or unstable coronary artery disease. Major new medical illness including renal disease requiring dialysis, a life-threatening illness with life expectancy less than six months, or cancer requiring chemotherapy or radiation treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent.] This is an exclusion because these conditions may interfere with the ability to fully participate in and complete the study.

12. MMSE score < 23 or dementia. This is an exclusion because it may interfere with the ability to fully participate in the study.

13. Non-English speaking, a visual impairment or a hearing impairment that interferes with study participation. This is an exclusion criterion because these potential participants may not be able to participate fully in the intervention.

14. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• Ideal Protein Weight Loss Method
An initial visit will take place in which each participant assigned to the experimental group will complete a health profile questionnaire.The Ideal Protein method will be explained and the participant will be weighed, measured and given diet related informational materials. A staff member will assist the participant with the selection of foods and snacks to ensure adequate quantity for the week. Weekly follow-up visits of 15 minutes duration will be implemented with a telephone follow-up occurring during the first 4 days after the initial appointment. For 12 weeks Ideal Protein foods that are of the appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute).
• Standard Weight Loss
This arm utilizes evidence-based strategies that have been shown to be effective for long-term weight loss and weight loss maintenance (including behavioral techniques, diet modification, and social support) consistent with the 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. Participants in this arm will have an initial one hour consultation with a trained interventionist, where the fat goal and calorie restriction goal are explained. For 12 weeks low-fat reduced calorie foods that are of appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute).

Locations

Country	Name	City	State
United States	Bogalusa Heart Study Clinic	Bogalusa	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	Ideal Protein

Country where clinical trial is conducted

United States, 

References & Publications (52)

Albenberg LG, Wu GD. Diet and the intestinal microbiome: associations, functions, and implications for health and disease. Gastroenterology. 2014 May;146(6):1564-72. doi: 10.1053/j.gastro.2014.01.058. Epub 2014 Feb 4. Review. — View Citation

Appel LJ, Brands MW, Daniels SR, Karanja N, Elmer PJ, Sacks FM; American Heart Association. Dietary approaches to prevent and treat hypertension: a scientific statement from the American Heart Association. Hypertension. 2006 Feb;47(2):296-308. — View Citation

Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. — View Citation

Appel LJ, Sacks FM, Carey VJ, Obarzanek E, Swain JF, Miller ER 3rd, Conlin PR, Erlinger TP, Rosner BA, Laranjo NM, Charleston J, McCarron P, Bishop LM; OmniHeart Collaborative Research Group. Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial. JAMA. 2005 Nov 16;294(19):2455-64. — View Citation

Arita Y, Kihara S, Ouchi N, Takahashi M, Maeda K, Miyagawa J, Hotta K, Shimomura I, Nakamura T, Miyaoka K, Kuriyama H, Nishida M, Yamashita S, Okubo K, Matsubara K, Muraguchi M, Ohmoto Y, Funahashi T, Matsuzawa Y. Paradoxical decrease of an adipose-specific protein, adiponectin, in obesity. 1999. Biochem Biophys Res Commun. 2012 Aug 31;425(3):560-4. doi: 10.1016/j.bbrc.2012.08.024. — View Citation

Banting W. Letter on corpulence, addressed to the public. 1869. Obes Res. 1993 Mar;1(2):153-63. — View Citation

Baumann P, Moran NA. Non-cultivable microorganisms from symbiotic associations of insects and other hosts. Antonie Van Leeuwenhoek. 1997 Jul;72(1):39-48. Review. — View Citation

Bazzano LA, Hu T, Reynolds K, Yao L, Bunol C, Liu Y, Chen CS, Klag MJ, Whelton PK, He J. Effects of low-carbohydrate and low-fat diets: a randomized trial. Ann Intern Med. 2014 Sep 2;161(5):309-18. doi: 10.7326/M14-0180. — View Citation

Boden G, Sargrad K, Homko C, Mozzoli M, Stein TP. Effect of a low-carbohydrate diet on appetite, blood glucose levels, and insulin resistance in obese patients with type 2 diabetes. Ann Intern Med. 2005 Mar 15;142(6):403-11. — View Citation

Brehm BJ, Seeley RJ, Daniels SR, D'Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab. 2003 Apr;88(4):1617-23. — View Citation

Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012 Mar 13;13(4):260-70. doi: 10.1038/nrg3182. Review. — View Citation

Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. Review. Erratum in: Obes Res 1998 Nov;6(6):464. — View Citation

Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. — View Citation

David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11. — View Citation

Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. — View Citation

Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. Erratum in: JAMA. 2007 Jul 11;298(2):178. — View Citation

GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1459-1544. doi: 10.1016/S0140-6736(16)31012-1. Erratum in: Lancet. 2017 Jan 7;389(10064):e1. — View Citation

Heun R, Papassotiropoulos A, Jennssen F. The validity of psychometric instruments for detection of dementia in the elderly general population. Int J Geriatr Psychiatry. 1998 Jun;13(6):368-80. — View Citation

Hodges RE, Rebello T. Carbohydrates and blood pressure. Ann Intern Med. 1983 May;98(5 Pt 2):838-41. — View Citation

Hu T, Mills KT, Yao L, Demanelis K, Eloustaz M, Yancy WS Jr, Kelly TN, He J, Bazzano LA. Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors: a meta-analysis of randomized controlled clinical trials. Am J Epidemiol. 2012 Oct 1;176 Suppl 7:S44-54. doi: 10.1093/aje/kws264. — View Citation

Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40. — View Citation

Johnston BC, Kanters S, Bandayrel K, Wu P, Naji F, Siemieniuk RA, Ball GD, Busse JW, Thorlund K, Guyatt G, Jansen JP, Mills EJ. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA. 2014 Sep 3;312(9):923-33. doi: 10.1001/jama.2014.10397. — View Citation

Kochanek KD, Murphy SL, Xu J, Tejada-Vera B. Deaths: Final Data for 2014. Natl Vital Stat Rep. 2016 Jun;65(4):1-122. — View Citation

Kritchevsky D. History of recommendations to the public about dietary fat. J Nutr. 1998 Feb;128(2 Suppl):449S-452S. doi: 10.1093/jn/128.2.449S. — View Citation

Kuczynski J, Lauber CL, Walters WA, Parfrey LW, Clemente JC, Gevers D, Knight R. Experimental and analytical tools for studying the human microbiome. Nat Rev Genet. 2011 Dec 16;13(1):47-58. doi: 10.1038/nrg3129. Review. — View Citation

Ley RE, Bäckhed F, Turnbaugh P, Lozupone CA, Knight RD, Gordon JI. Obesity alters gut microbial ecology. Proc Natl Acad Sci U S A. 2005 Aug 2;102(31):11070-5. Epub 2005 Jul 20. — View Citation

Lindsay RS, Funahashi T, Hanson RL, Matsuzawa Y, Tanaka S, Tataranni PA, Knowler WC, Krakoff J. Adiponectin and development of type 2 diabetes in the Pima Indian population. Lancet. 2002 Jul 6;360(9326):57-8. — View Citation

Meier U, Gressner AM. Endocrine regulation of energy metabolism: review of pathobiochemical and clinical chemical aspects of leptin, ghrelin, adiponectin, and resistin. Clin Chem. 2004 Sep;50(9):1511-25. Epub 2004 Jul 20. Review. — View Citation

Nordmann AJ, Nordmann A, Briel M, Keller U, Yancy WS Jr, Brehm BJ, Bucher HC. Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006 Feb 13;166(3):285-93. Review. Erratum in: Arch Intern Med. 2006 Apr 24;166(8):932. — View Citation

Pagoto SL, Appelhans BM. A call for an end to the diet debates. JAMA. 2013 Aug 21;310(7):687-8. doi: 10.1001/jama.2013.8601. — View Citation

Pischon T, Girman CJ, Rifai N, Hotamisligil GS, Rimm EB. Association between dietary factors and plasma adiponectin concentrations in men. Am J Clin Nutr. 2005 Apr;81(4):780-6. — View Citation

Qi L, Meigs JB, Liu S, Manson JE, Mantzoros C, Hu FB. Dietary fibers and glycemic load, obesity, and plasma adiponectin levels in women with type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1501-5. — View Citation

Reed D, McGee D, Yano K, Hankin J. Diet, blood pressure, and multicollinearity. Hypertension. 1985 May-Jun;7(3 Pt 1):405-10. — View Citation

Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748. — View Citation

Samaha FF, Iqbal N, Seshadri P, Chicano KL, Daily DA, McGrory J, Williams T, Williams M, Gracely EJ, Stern L. A low-carbohydrate as compared with a low-fat diet in severe obesity. N Engl J Med. 2003 May 22;348(21):2074-81. — View Citation

Seshadri P, Iqbal N, Stern L, Williams M, Chicano KL, Daily DA, McGrory J, Gracely EJ, Rader DJ, Samaha FF. A randomized study comparing the effects of a low-carbohydrate diet and a conventional diet on lipoprotein subfractions and C-reactive protein levels in patients with severe obesity. Am J Med. 2004 Sep 15;117(6):398-405. Erratum in: Am J Med. 2006 Feb;119(2):191. — View Citation

Seshadri P, Samaha FF, Stern L, Ahima RS, Daily D, Iqbal N. Adipocytokine changes caused by low-carbohydrate compared to conventional diets in obesity. Metab Syndr Relat Disord. 2005;3(1):66-74. doi: 10.1089/met.2005.3.66. — View Citation

Sharman MJ, Gómez AL, Kraemer WJ, Volek JS. Very low-carbohydrate and low-fat diets affect fasting lipids and postprandial lipemia differently in overweight men. J Nutr. 2004 Apr;134(4):880-5. — View Citation

Sharman MJ, Kraemer WJ, Love DM, Avery NG, Gómez AL, Scheett TP, Volek JS. A ketogenic diet favorably affects serum biomarkers for cardiovascular disease in normal-weight men. J Nutr. 2002 Jul;132(7):1879-85. — View Citation

Sondike SB, Copperman N, Jacobson MS. Effects of a low-carbohydrate diet on weight loss and cardiovascular risk factor in overweight adolescents. J Pediatr. 2003 Mar;142(3):253-8. — View Citation

Staessen J, Fagard R, Lijnen P, Amery A. Body weight, sodium intake and blood pressure. J Hypertens Suppl. 1989 Feb;7(1):S19-23. Review. — View Citation

Stamler J, Caggiula A, Grandits GA, Kjelsberg M, Cutler JA. Relationship to blood pressure of combinations of dietary macronutrients. Findings of the Multiple Risk Factor Intervention Trial (MRFIT). Circulation. 1996 Nov 15;94(10):2417-23. — View Citation

Stamler J, Liu K, Ruth KJ, Pryer J, Greenland P. Eight-year blood pressure change in middle-aged men: relationship to multiple nutrients. Hypertension. 2002 May;39(5):1000-6. — View Citation

Stern L, Iqbal N, Seshadri P, Chicano KL, Daily DA, McGrory J, Williams M, Gracely EJ, Samaha FF. The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Ann Intern Med. 2004 May 18;140(10):778-85. — View Citation

Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400. — View Citation

Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30. — View Citation

Volek JS, Sharman MJ, Gómez AL, DiPasquale C, Roti M, Pumerantz A, Kraemer WJ. Comparison of a very low-carbohydrate and low-fat diet on fasting lipids, LDL subclasses, insulin resistance, and postprandial lipemic responses in overweight women. J Am Coll Nutr. 2004 Apr;23(2):177-84. — View Citation

Volek JS, Sharman MJ, Gómez AL, Scheett TP, Kraemer WJ. An isoenergetic very low carbohydrate diet improves serum HDL cholesterol and triacylglycerol concentrations, the total cholesterol to HDL cholesterol ratio and postprandial pipemic responses compared with a low fat diet in normal weight, normolipidemic women. J Nutr. 2003 Sep;133(9):2756-61. — View Citation

Weinstock GM. Genomic approaches to studying the human microbiota. Nature. 2012 Sep 13;489(7415):250-6. doi: 10.1038/nature11553. Review. — View Citation

Weyer C, Funahashi T, Tanaka S, Hotta K, Matsuzawa Y, Pratley RE, Tataranni PA. Hypoadiponectinemia in obesity and type 2 diabetes: close association with insulin resistance and hyperinsulinemia. J Clin Endocrinol Metab. 2001 May;86(5):1930-5. — View Citation

Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1. — View Citation

Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77. — View Citation

* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Change in weight at follow-up	Baseline and three months
Secondary	Body Composition	Change in waist and hip circumference	Baseline and three months
Secondary	Body Composition	Change in lean and fat mass	Baseline and three months
Secondary	Lipid parameters	Change in lipid parameters	Baseline and three months
Secondary	Fasting glucose	Change in fasting glucose	Baseline and three months
Secondary	Continuously measured glucose	Change in continuously measured glucose	Baseline and three months
Secondary	Systolic Blood Pressure	Change in systolic blood pressure	Baseline and three months
Secondary	Diastolic Blood Pressure	Change in systolic blood pressure	Baseline and three months
Secondary	Appetite	Change in appetite as measured by self-report questionnaires	Baseline and three months
Secondary	Satiety	Change in satiety as measured by self-report questionnaires	Baseline and three months