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Great Diets For Weight Reduction Text
1. Diet and/or behavior modification:
Long-term results
-5
-5
0
0
WEight change (kg)
WEight change (kg)
-5
-5
-10
-10 VLCD
VLCD
Modified diet + behavior
Modified diet + behavior
modification
modification
-15
-15
VLCD + behavior modification
VLCD + behavior modification
-20
-20
1
1 2
2 3
3 4
4 5
5
Intervention
Intervention Years after intervention
Years after intervention
(adapdet from Wadden TA. Ann Intern Med 1993; 119:688-93)
(adapdet from Wadden TA. Ann Intern Med 1993; 119:688-93)
Ann Intern Med. 1993 Oct 1;119(7 Pt 2):688-93. Links
Treatment of obesity by moderate and severe caloric restriction. Results of clinical
research trials.
Wadden TA.
Syracuse University, New York.
Recent studies of the treatment of obesity by moderate and severe caloric restriction show that
patients treated in randomized trials using a conventional 1200 kcal/d reducing diet, combined
with behavior modification, lose approximately 8.5 kg in 20 weeks. They maintain
approximately two thirds of this weight loss 1 year later. Patients treated under medical
supervision using a very-low-calorie diet (400 to 800 kcal/d) lose approximately 20 kg in 12
to 16 weeks and maintain one half to two thirds of this loss in the following year. Both dietary
interventions are associated with increasing weight regain over time, although regain can be
minimized with the recognition that obesity, in many cases, is a chronic condition that
requires continuing care. Patients who participate in a formal weight-loss maintenance
program, exercise regularly, or both are likely to achieve the best long-term results.
PMID: 8363198 [PubMed - indexed for MEDLINE]
2. Comparison of Energy Densities
Prentice AM et al Obes Rev. 2003 Nov;4(4):187-94
Obes Rev. 2003 Nov;4(4):187-94. Links
Fast foods, energy density and obesity: a possible mechanistic link.
Prentice AM,
Jebb SA.
MRC International Nutrition Group, London School of Hygiene and Tropical Medicine, UK.
andrew.prentice@ishtm.ac.uk
Fast foods are frequently linked to the epidemic of obesity, but there has been very little
scientific appraisal of a possible causal role. Here we review a series of studies demonstrating
that the energy density of foods is a key determinant of energy intake. These studies show that
humans have a weak innate ability to recognise foods with a high energy density and to
appropriately down-regulate the bulk of food eaten in order to maintain energy balance. This
induces so called 'passive over-consumption'. Composition data from leading fast food
company websites are then used to illustrate that most fast foods have an extremely high
energy density. At some typical outlets the average energy density of the entire menus is
approximately 1100 kJ 100 g(-1). This is 65% higher than the average British diet
(approximately 670 kJ 100 g(-1)) and more than twice the energy density of recommended
healthy diets (approximately 525 kJ 100 g(-1)). It is 145% higher than traditional African
diets (approximately 450 kJ 100 g(-1)) that probably represent the levels against which human
weight regulatory mechanisms have evolved. We conclude that the high energy densities of
many fast foods challenge human appetite control systems with conditions for which they
were never designed. Among regular consumers they are likely to result in the accidental
consumption of excess energy and hence to promote weight gain and obesity.
PMID: 14649369 [PubMed - indexed for MEDLINE]
3. Consistent weight loss in clinical trials
Weight loss (%) Placebo + Xenical +
diet diet
12 p<0.001 p<0.001
10.2% p<0.001
10 9.7%
8.8%
8
6.1% 6.6%
6 5.8%
4
2
0
Sjöström Rössner Davidson
Sjöström L et al Lancet. 1998 Jul 18;352(9123):167-72
Rössner S et al Obes Res. 2000 Jan;8(1):49-61
Davidson MH et al JAMA. 1999 Jan 20;281(3):235-42
Lancet. 1998 Jul 18;352(9123):167-72.Related Articles, Links
Comment in:
Lancet. 1998 Jul 18;352(9123):160-1.
Lancet. 1998 Oct 31;352(9138):1473-4.
Lancet. 1998 Oct 31;352(9138):1473; author reply 1474.
Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight
regain in obese patients. European Multicentre Orlistat Study Group.
Sjostrom L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, Krempf M.
Sahlgrenska University Hospital, Goteborg, Sweden.
BACKGROUND: We undertook a randomised controlled trial to assess the efficacy and
tolerability of orlistat, a gastrointestinal lipase inhibitor, in promoting weight loss and
preventing weight regain in obese patients over a 2-year period. METHODS: 743 patients
(body-mass index 28-47 kg/m2), recruited at 15 European centres, entered a 4-week, single-
blind, placebo lead-in period on a slightly hypocaloric diet (600 kcal/day deficit). 688 patients
who completed the lead-in were assigned double-blind treatment with orlistat 120 mg (three
times a day) or placebo for 1 year in conjunction with the hypocaloric diet. In a second 52-
week double-blind period patients were reassigned orlistat or placebo with a weight
maintenance (eucaloric) diet. FINDINGS: From the start of lead-in to the end of year 1, the
orlistat group lost, on average, more bodyweight than the placebo group (10.2% [10.3 kg] vs
6.1% [6.1 kg]; LSM difference 3.9 kg [p<0.001] from randomisation to the end of year 1).
During year 2, patients who continued with orlistat regained, on average, half as much weight
as those patients switched to placebo (p<0.001). Patients switched from placebo to orlistat lost
an additional 0.9 kg during year 2, compared with a mean regain of 2.5 kg in patients who
continued on placebo (p<0.001). Total cholesterol, low-density lipoprotein (LDL) cholesterol,
LDL/high-density lipoprotein ratio, and concentrations of glucose and insulin decreased more
in the orlistat group than in the placebo group. Gastrointestinal adverse events were more
4. common in the orlistat group. Other adverse symptoms occurred at a similar frequency during
both treatments. INTERPRETATION: Orlistat taken with an appropriate diet promotes
clinically significant weight loss and reduces weight regain in obese patients over a 2-year
period. The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy
and adverse events.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 9683204 [PubMed - indexed for MEDLINE]
Obes Res. 2000 Jan;8(1):49-61.Related Articles, Links
Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years
treatment with orlistat for obesity. European Orlistat Obesity Study Group.
Rossner S, Sjostrom L, Noack R, Meinders AE, Noseda G.
Obesity Unit, Huddinge Hospital, Stockholm, Sweden. stephan.rossner@medhs.ki.se
OBJECTIVE: To determine the effect of orlistat, a new lipase inhibitor, on long-term weight
loss, to determine the extent to which orlistat treatment minimizes weight regain in a second
year of treatment, and to assess the effects of orlistat on obesity-related risk factors.
RESEARCH METHODS AND PROCEDURES: This was a 2-year, multicenter, randomized,
double-blind, placebo-controlled study. Obese patients (body mass index 28 to 43 kg/m2)
were randomized to placebo or orlistat (60 or 120 mg) three times a day, combined with a
hypocaloric diet during the first year and a weight maintenance diet in the second year of
treatment to prevent weight regain. Changes in body weight, lipid profile, glycemic control,
blood pressure, quality of life, safety, and tolerability were measured. RESULTS: Orlistat-
treated patients lost significantly more weight (p<0.001) than placebo-treated patients after
Year 1 (6.6%, 8.6%, and 9.7% for the placebo, and orlistat 60 mg and 120 mg groups,
respectively). During the second year, orlistat therapy produced less weight regain than
placebo (p = 0.005 for orlistat 60 mg; p<0.001 for orlistat 120 mg). Several obesity-related
risk factors improved significantly more with orlistat treatment than with placebo. Orlistat
was generally well tolerated and only 6% of orlistat-treated patients withdrew because of
adverse events. Orlistat leads to predictable gastrointestinal effects related to its mode of
action, which were generally mild, transient, and self-limiting and usually occurred early
during treatment. DISCUSSION: Orlistat administered for 2 years promotes weight loss and
minimizes weight regain. Additionally, orlistat therapy improves lipid profile, blood pressure,
and quality of life.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 10678259 [PubMed - indexed for MEDLINE]
5. JAMA. 1999 Jan 20;281(3):235-42.Related Articles, Links
Erratum in:
JAMA 1999 Apr 7;281(13):1174.
Comment in:
JAMA. 1999 Jan 20;281(3):278-80.
Weight control and risk factor reduction in obese subjects treated for 2 years with
orlistat: a randomized controlled trial.
Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D,
Heimburger DC, Lucas CP, Robbins DC, Chung J, Heymsfield SB.
Chicago Center for Clinical Research, Ill, USA.
CONTEXT: Orlistat, a gastrointestinal lipase inhibitor that reduces dietary fat absorption by
approximately 30%, may promote weight loss and reduce cardiovascular risk factors.
OBJECTIVE: To test the hypothesis that orlistat combined with dietary intervention is more
effective than placebo plus diet for weight loss and maintenance over 2 years. DESIGN:
Randomized, double-blind, placebo-controlled study conducted from October 1992 to
October 1995. SETTING AND PARTICIPANTS: Obese adults (body mass index [weight in
kilograms divided by the square of height in meters], 30-43 kg/m2) evaluated at 18 US
research centers. INTERVENTION: Subjects received placebo plus a controlled-energy diet
during a 4-week lead-in. On study day 1, the diet was continued and subjects were
randomized to receive placebo 3 times a day or orlistat, 120 mg 3 times a day, for 52 weeks.
After 52 weeks, subjects began a weight-maintenance diet, and the placebo group (n = 133)
continued to receive placebo and orlistat-treated subjects were rerandomized to receive
placebo 3 times a day (n = 138), orlistat, 60 mg (n = 152) or 120 mg (n = 153) 3 times a day,
for an additional 52 weeks. MAIN OUTCOME MEASURES: Body weight change and
changes in blood pressure and serum lipid, glucose, and insulin levels. RESULTS: A total of
1187 subjects entered the protocol, and 892 were randomly assigned on day 1 to double-blind
treatment. For intent-to-treat analysis, 223 placebo-treated subjects and 657 orlistat-treated
subjects were evaluated. During the first year orlistat-treated subjects lost more weight (mean
+/- SEM, 8.76+/-0.37 kg) than placebo-treated subjects (5.81+/-0.67 kg) (P<.001). Subjects
treated with orlistat, 120 mg 3 times a day, during year 1 and year 2 regained less weight
during year 2 (3.2+/-0.45 kg; 35.2% regain) than those who received orlistat, 60 mg (4.26+/-
0.57 kg; 51.3% regain), or placebo (5.63+/-0.42 kg; 63.4% regain) in year 2 (P<.001).
Treatment with orlistat, 120 mg 3 times a day, was associated with improvements in fasting
low-density lipoprotein cholesterol and insulin levels. CONCLUSIONS: Two-year treatment
with orlistat plus diet significantly promotes weight loss, lessens weight regain, and improves
some obesity-related disease risk factors.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 9918478 [PubMed - indexed for MEDLINE]
6. Xenical: Long-term weight reduction
Veränderung Körpergewicht (%)
0 Placebo
Xenical® 60mg
-2 Xenical® 120mg
*p<0.01
-4
-6
-8
-10
-4 0 10 20 30 40 52 60 70 80 90 104
Sjöström L et al Lancet. 1998 Jul 18;352(9123):167-72
Lancet. 1998 Jul 18;352(9123):167-72.Related Articles, Links
Comment in:
Lancet. 1998 Jul 18;352(9123):160-1.
Lancet. 1998 Oct 31;352(9138):1473-4.
Lancet. 1998 Oct 31;352(9138):1473; author reply 1474.
Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight
regain in obese patients. European Multicentre Orlistat Study Group.
Sjostrom L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, Krempf M.
Sahlgrenska University Hospital, Goteborg, Sweden.
BACKGROUND: We undertook a randomised controlled trial to assess the efficacy and
tolerability of orlistat, a gastrointestinal lipase inhibitor, in promoting weight loss and
preventing weight regain in obese patients over a 2-year period. METHODS: 743 patients
(body-mass index 28-47 kg/m2), recruited at 15 European centres, entered a 4-week, single-
blind, placebo lead-in period on a slightly hypocaloric diet (600 kcal/day deficit). 688 patients
who completed the lead-in were assigned double-blind treatment with orlistat 120 mg (three
times a day) or placebo for 1 year in conjunction with the hypocaloric diet. In a second 52-
week double-blind period patients were reassigned orlistat or placebo with a weight
maintenance (eucaloric) diet. FINDINGS: From the start of lead-in to the end of year 1, the
orlistat group lost, on average, more bodyweight than the placebo group (10.2% [10.3 kg] vs
6.1% [6.1 kg]; LSM difference 3.9 kg [p<0.001] from randomisation to the end of year 1).
During year 2, patients who continued with orlistat regained, on average, half as much weight
as those patients switched to placebo (p<0.001). Patients switched from placebo to orlistat lost
an additional 0.9 kg during year 2, compared with a mean regain of 2.5 kg in patients who
continued on placebo (p<0.001). Total cholesterol, low-density lipoprotein (LDL) cholesterol,
LDL/high-density lipoprotein ratio, and concentrations of glucose and insulin decreased more
7. in the orlistat group than in the placebo group. Gastrointestinal adverse events were more
common in the orlistat group. Other adverse symptoms occurred at a similar frequency during
both treatments. INTERPRETATION: Orlistat taken with an appropriate diet promotes
clinically significant weight loss and reduces weight regain in obese patients over a 2-year
period. The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy
and adverse events.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 9683204 [PubMed - indexed for MEDLINE]
Xenical: XENDOS-results
Placebo + Xenical +
(kg) 0 lifestyle modification lifestyle modification
–3
–4,1 kg
–6
–6,9 kg
–9
p<0.001 vs. Placebo
–12
0 52 104 156 208
Woche
Torgerson JS et al Diabetes Care. 2004 Jan;27(1):155-61
Diabetes Care. 2004 Jan;27(1):155-61.Related Articles, Links
Erratum in:
Diabetes Care. 2004 Mar;27(3):856.
XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized
study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in
obese patients.
Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L.
Department of Body Composition and Metabolism, Sahlgrenska University Hospital,
Goteborg, Sweden.
OBJECTIVE: It is well established that the risk of developing type 2 diabetes is closely linked
to the presence and duration of overweight and obesity. A reduction in the incidence of type 2
diabetes with lifestyle changes has previously been demonstrated. We hypothesized that
8. adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in
body weight, and thus the incidence of type 2 diabetes, in obese patients. RESEARCH
DESIGN AND METHODS: In a 4-year, double-blind, prospective study, we randomized
3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo, three times daily.
Participants had a BMI >/=30 kg/m2 and normal (79%) or impaired (21%) glucose tolerance
(IGT). Primary endpoints were time to onset of type 2 diabetes and change in body weight.
Analyses were by intention to treat. RESULTS: Of orlistat-treated patients, 52% completed
treatment compared with 34% of placebo recipients (P < 0.0001). After 4 years' treatment, the
cumulative incidence of diabetes was 9.0% with placebo and 6.2% with orlistat,
corresponding to a risk reduction of 37.3% (P = 0.0032). Exploratory analyses indicated that
the preventive effect was explained by the difference in subjects with IGT. Mean weight loss
after 4 years was significantly greater with orlistat (5.8 vs. 3.0 kg with placebo; P < 0.001)
and similar between orlistat recipients with impaired (5.7 kg) or normal glucose tolerance
(NGT) (5.8 kg) at baseline. A second analysis in which the baseline weights of subjects who
dropped out of the study was carried forward also demonstrated greater weight loss in the
orlistat group (3.6 vs. 1.4 kg; P < 0.001). CONCLUSIONS: Compared with lifestyle changes
alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2
diabetes over 4 years and produced greater weight loss in a clinically representative obese
population. Difference in diabetes incidence was detectable only in the IGT subgroup; weight
loss was similar in subjects with IGT or NGT [correction].
Publication Types:
Clinical Trial
Randomized Controlled Trial
PMID: 14693982 [PubMed - indexed for MEDLINE]