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
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.
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.
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.
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.
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  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 . 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 . Very-low-
. Furthermore, studies in humans indicate the soy protein
energy diets (VLED) have enabled many obese individuals to
has specific effects on serum lipoproteins , increases insu-
lose substantial amounts of weight and maintain these losses
lin sensitivity  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
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-
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.
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,
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-
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 . 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
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 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
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
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%
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  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.  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.
Overall dropout rates were higher than usually seen in our
No serious adverse events or side effects were reported.
clinical trials based on published  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  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 . 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 , 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% . 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 . Haddock  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 . In our recentmeta-analysis of weight loss from four studies including 405non-diabetic subjects consuming two Milk MR daily the aver-
age weight loss at 12 weeks was 6.9% (95% CI, 6.0 –7.8%). Heymsfield and colleagues  analyzed data from six
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LIST OF DANGEROUS GOODS - UPDATED NA = Classification not available within SPA BylawNC = No change to classification according to SPA Bylaw Proposed Classification New/Revised To SPA Bylaw Classification Explosive FUZES DETONATING with protective featuresDETONATORS ASSEMBLIES NON-ELECTRIC for blastingARTICLES, PYROTECHNIC for technical purposesRECEPTACLES SMALL,CONTAIN
Hudsarkoidos Förekomst Hudförändringar vid sarkoidos uppträder hos 20-25 % av patienterna och oftast samtidigt med andra sarkoidosmanifestationer [1,2]. Typ och förekomst av hudförändringar påverkas av rastillhörighet och kön och har olika prognostisk innebörd. Hudförändringar är vanligare hos kvinnor än hos män. De kan vara av ospecifik typ – erythema nodosum, EN –