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Original Research
Weight Loss and Lipid Changes with Low-Energy Diets:
Comparator Study of Milk-Based versus Soy-Based
Liquid Meal Replacement Interventions
James W. Anderson, MD and Lars H. Hoie, MD
Department of Internal Medicine, University of Kentucky, Lexington, Kentucky (J.W.A.), NutriPharma, Oslo, Norway (L.H.H.) Key words: clinical trial, obesity, meal replacements, serum cholesterol, soy protein, weight loss
Objectives: Soy protein intake has favorable effects on body weight and fat distribution in experimental
animals but these effects have not been demonstrated in humans. To compare effects of soy- vs. milk-based meal replacements (MR) we assessed weight loss and serum lipoproteins changes for obese subjects who consumed low-energy diets (LED) including either milk-based or soy-based MR.
Methods: Overweight or obese women and men (body mass indices 27– 40 kg/m2) were randomly assigned
to LED providing 1200 kcal/day, with consumption of five soy-based or two milk-based liquid MR for a 12-week weight loss trial. Serum lipoprotein measurements were obtained at baseline, 6 and 12 weeks.
Results: For soy and milk MR groups, subject numbers were, respectively, 51 and 39 randomized and 30
and 22 completers. MR use averaged: soy, 3.7/day; and milk, 1.9/day. Weight losses for completers at 12 weeks were: soy MR, 9.0% of initial body weight (95% confidence intervals, 7.3–10.6%); and milk MR, 7.9% (5.8 – 8.8%) with no significant differences. Reductions from baseline in serum cholesterol and LDL-cholesterol values, respectively, at six weeks were significantly greater (P Ͻ 0.015) with soy MR (15.2% and 17.4%) thanwith milk MR (7.9% and 7.7%). Soy MR use was associated with significant reductions in serum triglycerides at 6 and 12 weeks while milk MR use was not.
Conclusions: Soy MR use, as part of a low-energy diet, was associated with slightly but not significantly
greater weight loss over a 12-week period than milk MR use. These observations confirm previous studies documenting the effectiveness of MR use for weight loss.
INTRODUCTION
Soy protein has been used as a principal ingredient of liquid MR for treatment of obese individuals for two decades [9,10].
Obesity is increasing at epidemic rates in the United States Soy protein has been the protein component of a widely used and worldwide [1,2]. About two-thirds of U.S. adults are over- VLED in Scandinavia over the past 15 years [11,12]. Labora- weight [2] and the prevalence of Class 3 or extreme obesity has tory studies—in vitro and with animal models—suggest that almost tripled in the last 10 years [3]. In addition to preventive soy protein has selective effects on upregulation of genes measures, more intensive treatments are required to manage involved in glucose and lipid metabolism, enhances insulin obese individuals. Unfortunately, many obese individuals are sensitivity, and promotes a select loss of visceral adipose tissue not successful in losing weight and have even more difficultymaintaining a lower body weight long-term [4]. Very-low- [10]. Furthermore, studies in humans indicate the soy protein energy diets (VLED) have enabled many obese individuals to has specific effects on serum lipoproteins [13], increases insu- lose substantial amounts of weight and maintain these losses lin sensitivity [14] and may protect from development of dia- [4,5]. More recently less intensive interventions using liquid MR (shakes) have emerged as an effective weight loss and The purpose of this study was to compare weight loss and weight maintenance strategy for some individuals [6 – 8].
serum lipid changes with two popular MR that are widely Address reprint requests to: James W. Anderson, MD, 1030 South Broadway, Lexington, KY 40504-2681. E-mail: [email protected].
Support: Dr. Anderson: HCF Nutrition Fdn., Veterans Administration, Abbott, Amylin, Arena, Astra-Zenica, Cargill, General Nutrition Centers, GlaxoSmithKline, HealthManagement Resources, Herbalife, Kellogg, Merck, Revival Soy, Roche, Sanofi, and Solae. Dr. Hoie: Board of Directors of NutriPharma, licenser of Scan-Diet™.
Journal of the American College of Nutrition, Vol. 24, No. 3, 210–216 (2005)Published by the American College of Nutrition Weight Loss with Meal Replacements available and are purchased by consumers for self-help weight baseline physical and laboratory measurements were com- loss efforts. One MR shake was milk based and the other soy pleted. Subjects were assigned screening numbers consecu- based. These products were provided to volunteers with mini- tively at the initial clinic visit. They were randomly assigned to mal lifestyle counseling or behavioral intervention to mimic the treatment groups based their screening number and a random self-help activities that these individuals might perform after number series. Study staff were blinded to assignment until the subject was randomized to the study product group.
Subjects were randomized to use either five soy-based meal replacements (Soy MR) or two milk-based meal replacements MATERIALS AND METHODS
(Milk MR) per day. A registered dietitian instructed eachsubject in use of a 1200 kcal diet to include the MR. Subjects Subjects
randomized to the Soy MR were encouraged to include fruitsand vegetables while subjects using Milk MR were instructed This study was conducted by the Metabolic Research Group to include fruits, vegetables, and two servings of lean meat such at the University of Kentucky. Subjects were eligible for in- as breast of chicken or turkey. Soy MR (Scan-Diet™) is a clusion if they met all of the following enrollment criteria: age widely available powder that was mixed with water to form a 18 – 65 years; body mass index (BMI) 27– 40 kg/m2; serum shake; subjects were instructed to take five Soy MR shakes cholesterol concentrations Ͼ230 mg/dL or LDL-cholesterolϾ daily. The Milk MR (Slim-Fast௡) is a widely available powder 135 mg/dL; able to provide signed, written informed consent; that is mixed with 8 ounces of skim milk to make a shake; female who was either of non-childbearing potential or agreed subjects were instructed to take two shakes daily. The products to follow an acceptable birth control method. Subjects were not were used as directed by the product information. Nutrient enrolled in the study if they met any of the following exclusion information for the two powdered MR is presented in Table 1.
criteria: pregnancy or breast feeding; history of bulimia or To more closely mimic the practice that consumers would anorexia nervosa; cardiovascular disease; uncontrolled hyper- follow, only limited nutrition information was provided to tension; diabetes mellitus; fasting serum triglyceride valueϾ subjects. They were given a lifestyle diary and instructed to 450 mg/dl; treatment with lipid-lowering agent; untreated record MR use, food intake, and physical activity in 10 minute hypothyroidism; significant variation in weight (Ն4 kg) in the blocks. The main purpose of using the lifestyle diary was to past 6 months; current use of medication or herbal product for collect information about MR use since detailed food intake weight loss; prior surgical intervention for the treatment of obesity; history of severe renal, hepatic, neurological, chronicpulmonary disease, or any other unstable medical disorder;depression, panic disorder, psychosis, or bipolar disorder; his- Assessments
tory of alcohol or substance abuse; or risk of non-compliancewith study procedures.
Subjects returned to the clinic every two weeks. At each Each subject signed and dated an informed consent form visit, current medication use was reviewed and symptoms or that was witnessed before undertaking any screening proce- side effect information was recorded. At baseline and 12 weeks dures. This protocol was approved by the Institutional Review waist circumference measures were obtained. At each visit Board at the University of Kentucky.
Protocol
Table 1. Composition of products used1
This was a 12-week, randomized, controlled, parallel group study. Because of differences in the number of shakes used daily and the preparation of the shakes, blinding of the study was not possible. Subjects volunteered for the study after seeing newspaper advertisements, hearing about the study or being contracted because of a prior interest in this type of research. After screening by telephone, subjects were sched- uled for a screening visit where the informed consent was reviewed and signed. A detailed history and medication review was performed; blood and urine specimens were obtained for screening. Eligible subjects returned for a second visit for review of laboratory results and physical examination. Eligible Recommended daily intake was five soy MR shakes or two milk MR shakes subjects were scheduled for the randomization visit. At the 2 Scan-Diet™, vanilla, one packet, 49 grams.
second visit subjects were given a lifestyle diary and instructed 3 Slim-Fast௡, Chocolate Fudge Shake Mix, one scoop, 28 grams.
to record food intake and physical activity. At randomization, 4 Milk MR mixed in 8 fluid ounces of fat-free milk.
JOURNAL OF THE AMERICAN COLLEGE OF NUTRITION Weight Loss with Meal Replacements weight, pulse and blood pressure were measured. Blood sam- were: Soy MR, 47.3 Ϯ 9.4 (SD) years and Milk MR, 47.6 Ϯ ples after a 12-hour, overnight fast were obtained at random- 9.4 years. The average BMIs were: Soy MR, 34.8 Ϯ 3.2 kg/m2 ization (baseline), 6 and 12 weeks for lipid measurements, and and Milk MR, 34.2 Ϯ 2.7 kg/m2. Mean ages and BMIs did not at baseline and 12 weeks, a chemistry panel including glucose, liver and renal function tests was obtained. At every clinic visitthe dietitian reviewed the lifestyle diary for completeness, Early Withdrawals
encouraged the subject and answered questions.
Quest Diagnostic Laboratories, Louisville, KY, performed Thirty of 51 subjects (58.8%) completed the Soy MR inter- vention while 22 of 39 subjects (56.4%) completed the MilkMR intervention. Subjects withdrew from the Soy MR inter- Statistical Analyses
vention earlier than with Milk MR. Before the return visit at 2weeks 9 Soy MR subjects had withdrawn while only 3 Milk The primary endpoints were the absolute and percentage MR subjects had withdrawn. The early withdrawals from the change from baseline body weight at 6 and 12-weeks and Soy MR intervention were related to intolerance to the product.
change in serum cholesterol and LDL-cholesterol values be- However, more Milk MR withdrew later in the study so that tween baseline and 6 and 12 weeks. The conservative power overall withdrawal rate did not differ significantly; 21 of 51 analysis approach led to an unpaired two-way t-test analysis.
subjects (41.2%) did not complete the Soy MR intervention Sample size calculations were based on data from previous while 17 of 39 subjects (43.6%) did not complete the Milk MR clinical trials at the University of Kentucky [16]. Since we did not anticipate large differences in weight loss between groups Ten subjects withdrew early related to side effects; 3 sub- we did power calculations based on differences between serum jects reported increased gas or more frequent bowel movements cholesterol changes (6 or 12-week minus baseline) comparing with the Soy MR. Seven subjects withdrew early because they changes for Soy MR with those for Milk MR. We calculated could not tolerate the supplement (6 Soy MR and 1 Milk MR).
the minimum sample size to detect a difference in serum Eleven subjects withdrew reporting they were too busy to cholesterol of 3% and assumed a standard deviation of 5%. We continue participation (3 Soy MR and 8 Milk MR). Seventeen calculated that 30 subjects would be required per treatment subjects did not return for follow-up and did not return phone group to detect a 3% difference with a significance of ␣ ϭ 0.05 All continuous variables were analyzed as change from Supplement and Lifestyle Diary Compliance
baseline. We used the mixed model approach and analyzed datafor completers and for the last-observation-carried-forward Subjects maintained lifestyle diaries in an excellent (defined (LOCF) or intention-to-treat (ITT) group. Triglyceride values as Ͼ90%) fashion during the first six weeks. The completion were analyzed without and with logarithmic transformation.
rates of diaries 6- and 12-weeks were as follows: Soy MR,91.4% and 80.0%, respectively; and Milk MR, 90.6% and86.4%, respectively. With the Soy MR intervention, subjects reported a lower percentage of recommended intake of shakesthan with Milk MR. The recommended use of Soy MR was 5 Screened Subjects
shakes daily; subjects consumed an average of 3.7 shakes daily We screened 133 subjects for this study and 43 (31%) were at 5 and 6 weeks and an average of 3.7 shakes daily at 11 and not eligible. Based on lipid criteria we excluded 39 subjects 12 weeks. The recommended use of Milk MR was 2 shakes with 30 having serum lipids too low to meet criteria and 9 daily; subjects consumed 1.9 shakes at 5 and 6 weeks and 1.9 having values too high. Two subjects were excluded because of recent weight changes and 2 subjects did not meet the BMIcriteria.
Weight Loss
Randomization
Weight losses by week are summarized in Table 2. Subjects using Soy MR lost more weight at each week than with Milk Because of high early dropout rates in the Soy MR group, MR use but these differences were not significant. With the Soy subjects were randomized at a 2:1 ratio to Soy MR vs. Milk MR MR, the weight losses as percentage of initial body weight were during the middle third of the study. Fifty-one subjects were as follows: 2 weeks, 2.6%; 4 weeks, 4.0%; 6 weeks, 5.8%; 8 assigned to Soy MR and 39 subjects were assigned to Milk MR.
weeks, 6.7%; 10 weeks, 7.5%; and 12 weeks, 9.0% (95%confidence intervals (CI), 7.3 to 10.6%). With the Milk MR, the Demographic Characteristics of Subjects
weight losses were as follows: 2 weeks, 2.5%; 4 weeks, 3.7%; The Soy MR subjects included 47 women and 4 men while 6 weeks, 5.1%; 8 weeks, 5.9%; 10 weeks, 6.8%; and 12 weeks, the Milk MR included 32 women and 7 men. The average ages Weight Loss with Meal Replacements Table 2. Weight loss over time with “available cases” and LOCF or ITT analyses1
1 Values are percentage change from baseline value with mean and 95% confidence intervals.
2 “No.” is number of subjects completing visit at designated week.
3 Abbreviations: LCI, lower confidence intervals; UCI, upper confidence intervals.
With the ITT analysis subjects with Soy MR lost 17% more Serum LDL-Cholesterol Changes
weight at 12 weeks than subjects with Milk MR but the differ- LDL-cholesterol values followed the same pattern as cho- ences between diets were not statistically significant (Table 2).
lesterol values. Values for both interventions were significantly At 12 weeks with the ITT analysis the weight losses were as reduced from baseline at 6 weeks (P Ͻ 0.001) but only Soy MR follows: Soy MR, 7.3% of initial body weight (95% CI, 5.8 – values were significantly reduced at 12 weeks. The values for 8.8%) and Milk MR, 6.2% of initial body weight (95% CI, Soy MR were as follows: 6 weeks, Ϫ17.4% (95% CI, Ϫ12.1 to Ϫ22.7%); and 12 weeks, Ϫ7.5% (Ϫ1.5 to Ϫ13.5%). Thevalues for Milk MR were as follows: 6 weeks, Ϫ7.7% (95% CI,Ϫ2.3 to Ϫ13.0%); and 12 weeks, Ϫ2.4% (6.3 to Ϫ11.0%). This Waist Circumference Changes
difference between Soy MR and Milk MR at 6 weeks was Both the Soy MR and the Milk MR groups had significant statistically significant (P ϭ 0.0136).
reductions in waist circumferences (P Ͻ 0.0001). The Soy MRgroup had larger reductions in waist circumferences (Ϫ10.6%) Serum Triglyceride Changes
than the Milk MR group (Ϫ8.0%) but these differences did notdiffer significantly (P ϭ 0.21).
Triglyceride values were significantly reduced at weeks 6 and 12 with the Soy MR but not with Milk MR. At 6 weeks,values for the Soy MR were Ϫ13.4% (95% CI, Ϫ4.1 to Serum Cholesterol Changes
Ϫ22.7%) while values for Milk MR were 0.8% (95% CI,Ϫ11.4 to 12.9%). At 12 weeks values for the Soy MR were Cholesterol changes were larger at 6 weeks than 12 weeks Ϫ20.1% (95% CI, Ϫ8.9 to Ϫ31.3%) while values for Milk MR with both diets (Table 3). Both diets significantly decreased were 0.4% (95% CI, 17.2 to Ϫ21.1%). The analysis of log- values at 6 weeks (P Ͻ 0.001). The Soy MR was associated transformed triglyceride values yielded similar results. Milk with consistently lower serum cholesterol values than the Milk MR intake was not associated with significant changes in MR. At 6 weeks cholesterol values were Ϫ15.2% (95% CI, serum triglyceride values whereas Soy MR intake was associ- Ϫ11.3 to Ϫ19.2%) with the Soy MR and Ϫ7.9% (95% CI, ated with significant reductions at 6 weeks (P ϭ 0.0006) and 12 Ϫ4.7 to Ϫ11.1%) with Milk MR. This difference between Soy MR and Milk MR was statistically significant (P ϭ 0.0069).
At 12 weeks serum cholesterol values were significantly Serum HDL-Cholesterol Changes
lower than baseline with the Soy MR but not with Milk MR.
Values for the Soy MR were Ϫ9.8% (95% CI, Ϫ5.4 to At 6 weeks reductions in HDL-cholesterol values with Milk Ϫ14.3%) while values for Milk MR were Ϫ4.9% (95% CI, 0.8 MR were significant while reductions with Soy MR were not. At to Ϫ10.6%). The difference between Soy MR and Milk MR 6 weeks, values for the Soy MR were Ϫ2.9% (95% CI, ϩ2.6 to was not statistically significant (P ϭ 0.184).
Ϫ8.3) while values for Milk MR were Ϫ6.0% (95% CI, Ϫ1.4 to JOURNAL OF THE AMERICAN COLLEGE OF NUTRITION Weight Loss with Meal Replacements Table 3. Comparison of outcome measures at 6 and 12 weeks1
* Significantly different from baseline, P Ͻ 0.05 or as provided in text.
** Significantly different from Milk MR, P Ͻ 0.05 or as provided in text.
1 Mean baseline values and percentage change from baseline are provided with significant differences indicated.
2 na ϭ not applicable.
Ϫ10.6%). At 12 weeks values for the Soy MR were Ϫ1.3% (95% DISCUSSION
CI, ϩ4.5 to Ϫ7.2%) while values for Milk MR were Ϫ1.3% (95%CI, ϩ5.6 to Ϫ8.2%).
For Ͼ20 years soy-based weight loss products have been used effectively for weight loss for obese subjects [9 –11].
Serum Glucose Changes
While most published reports have focused on VLED [17–22],several studies have used LED [12] or energy-restricted diets At 12 weeks reductions in glucose were significant with the with Ͼ1500 cal/day [20,23]. The randomized controlled study Soy MR (Ϫ3.6%, 95% CI, Ϫ1.1 to Ϫ6.1%) but not with Milk of Allison et al. [24] compared efficacy of a Soy MR to an MR (Ϫ2.9%, 95% CI, ϩ0.2 to Ϫ6.0%); these changes between intervention of limited diet instruction. Our current random- Soy MR and Milk MR did not differ significantly.
ized, controlled study compared the efficacy of the Soy MR asrecommended on the product information with Milk MR asrecommended on the product information. All subjects were Blood Pressure Changes
instructed to a 1200 kcal/day LED that included either 5 pack- Both diet interventions were accompanied by small reduc- ets of Soy MR or 2 packets of Milk MR daily.
tions in average blood pressure that were maximal at 6 weeks.
This study confirms the efficacy and safety of meal replace- While reductions in systolic blood pressure were significant at ments for weight loss for obese individuals. This comparator 6 weeks with the Soy MR, differences between diets were not trial evaluated the efficacy of the Soy MR intervention with the significant. At 6 weeks the following systolic and diastolic Milk MR intervention. A limitation of the study is that blinding blood changes were noted: Soy MR, Ϫ6.2 (95% CI, Ϫ2.5 to was not possible because the Soy MR group was instructed to Ϫ9.9) and Ϫ1.7 mmHg, not significant (ns); Milk MR, Ϫ2.7 (ns) use 5 packets daily while the Milk MR group was instructed to and Ϫ1.1 mmHg (ns). At 12 weeks the following systolic and use 2 packets daily. Furthermore, the Soy MR powder was diastolic blood changes were noted: Soy MR, Ϫ1.5 (ns) and Ϫ3.1 mixed in water while the Milk MR powder was mixed in skim mmHg (ns); Milk MR, Ϫ4.4 (ns) and Ϫ2.4 mmHg (ns).
milk. Nevertheless, we compared the two interventions asconsumers would be instructed to use them based on theproduct information.
Side Effects
Overall dropout rates were higher than usually seen in our No serious adverse events or side effects were reported.
clinical trials based on published [16] and unpublished data Three subjects reported increased belching or flatulence and (Anderson JW, unpublished observations). For example, in a more frequent bowel movements on the Soy MR.
similar trial we enrolled 71 subjects and 56 (79%) completed Weight Loss with Meal Replacements the 12-week intervention (Anderson JW, unpublished observa- emerging evidence that soy protein intake increases insulin tions). By design, the behavioral intervention was less intense sensitivity [14] and may even act to slow the development of than we usually employ because consumers will ordinarily use these products without nutrition counseling. For example, we Subjects taking four to five shakes daily had more modifi- did not employ our usual practice of providing pedometers and cation of their eating behavior than those taking two shakes monitoring daily steps or miles walked [16]. However, dropout daily; this may have contributed to differences in weight loss.
rates did not differ significantly between the two groups.
In addition to differences in source of protein, there may have Compliance to lifestyle diary use was excellent in both diet been other differences in the nutrient intake of the two study groups at 6 weeks and did not differ significantly. At six weeks, groups. Subjects in the Soy MR group consumed more protein, over 90% of subjects had maintained diary entries and reported calcium and fiber with their product than did those in the Milk number of shakes used daily. At 12 weeks, 77.8% of subjects MR group. These differences in protein [28], calcium [29,30] using the Soy MR and 86.4% of subjects using the Milk MR or fiber [31,32] may have contributed to weight loss differ- were compliant with lifestyle diary use. Overall, compliance to lifestyle diary use was 85.5% with Soy MR and 88.9% with The weight loss of ϳ8.5% of initial body weight at 12 Milk MR. Most subjects did not use 5 packets of Soy MR daily weeks using combined data from both MR groups is equivalent and the average use was 3.7 packets daily (74% of recom- to or greater than would be expected with intensive behavioral mended). However, most subjects used 2 packets of Milk MR interventions. In our meta-analysis of 10 behavioral programs daily and the average use was 1.9 packets daily (95% of using low-energy diets (Յ1500 kcal/day) the average weight recommended). The Soy MR shakes were considered less ac- loss at 12 weeks was 7.9% [9]. Furthermore, the observed ceptable than the Milk MR shakes. However, dropout rates weight loss of 8 –9% of initial body weight with the meal after 6 weeks were lower with the Soy MR (8 of 35 subjects, replacements is approximately twice that reported with phar- 22.9%) than with Milk MR (10 of 32 subjects, 31.3%).
macotherapy [33]. Haddock [33] asserts that net weight loss The weight loss of ϳ8.5% for the combined groups com- (i.e., treatment minus control weight loss) never exceeds 4% of pares very favorably with values reported in the literature.
Allison reported weight losses of 7.6% of initial body weightusing a similar protocol with Soy MR [24]. In our recentmeta-analysis of weight loss from four studies including 405non-diabetic subjects consuming two Milk MR daily the aver- REFERENCES
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