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Long-term effects of popular dietary approaches on weight loss and features of insulin resistance

Abstract

Objective:

High-carbohydrate (HC)–high-fibre diets are recommended for weight loss and for treating and preventing diseases such as diabetes and cardiovascular disease. We report a randomised trial comparing high-fat (HF) and high-protein (HP) diets with the conventional approach.

Research design and methods:

A total of 93 overweight insulin-resistant women received advice following randomisation to HF, HP or HC dietary regimes, to achieve weight loss followed by weight maintenance over 12 months. Weight, body composition and measures of carbohydrate and lipid metabolism were investigated.

Results:

Retention rates were 93% for HP and 75% for HC and HF. Features of the metabolic syndrome improved in all groups during the first 6 months, to a greater extent on HF and HP than an HC. During the second 6 months the HF group had increases in waist circumference (mean difference 4.4 cm (95% CI 3.0, 5.8)), fat mass (2.3 kg (1.5, 3.1)), triglycerides (0.28 mmol/l (0.09, 0.46)) and 2 h glucose (0.70 mmol/l (0.22, 1.18)). Overall there was substantial sustained improvement in waist circumference, triglycerides and insulin in the HP group and sustained but more modest changes on HC. Dietary compliance at 12 months was poor in all groups.

Conclusions:

HP and HC approaches appear to be appropriate options for insulin-resistant individuals. When recommending HP diets appropriate composition of dietary fat must be ensured. HC diet recommendations must include advice regarding appropriate high-fibre, low glycaemic index foods.

Introduction

Insulin resistance (IR) is considered to be the underlying abnormality in most cases of type 2 diabetes, and lifestyle intervention is thought to offer the greatest hope of reducing the risk of progression from IR to type 2 diabetes as well as reducing the risk of cardiovascular disease associated with IR. Excess adiposity is a major determinant of IR, and weight loss is almost always associated with increased insulin sensitivity. However, there is much less certainty regarding the optimal dietary prescription for achieving weight loss and improved insulin sensitivity and cardiovascular risk status. Many national and international organisations recommend an average to high-carbohydrate (HC) diet for treatment as well as prevention of diabetes, with the suggestion that intact fruit and vegetables and wholegrain products should provide as much as possible total dietary carbohydrate.1, 2, 3 High-fibre, low glycaemic index foods are encouraged. Recently, there has been increasing interest in low carbohydrate–high fat (HF) (e.g. Atkins)4 and high protein (HP) (e.g. Zone)5 diets, which have been shown in many studies of free-living individuals to be associated with impressive weight loss and improved cardiovascular risk indicators over a relatively short period of time (up to 6 months).6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Very few data are available relating to long-term (12 months or greater) comparisons of such alternative dietary regimens6, 17, 18, 19, 20 and only one study has been published that compares HP, HF and the more widely recommended HC–high-fibre diet over a prolonged period.21 We have previously reported a 6-month comparison of such diets in overweight insulin-resistant women.22 We report here on the sustainability of these diets in free-living insulin-resistant women 12 months after their prescription. In addition to the clinical and biochemical measures, differences in hunger and satiety, mood states, exercise levels and bowel frequency are compared between the three groups.

Methods

Participants and study design

The participants, study design and dietary interventions have been described previously.22 Briefly, 96 insulin-resistant women were initially randomised to one of three dietary intervention groups: HC–high-fibre, low carbohydrate–high fat (HF) or a relatively HP diet (HP). Three women withdrew prior to receiving dietary advice and were excluded from the analysis. Each participant was given detailed dietary advice according to group allocation. Advice during the first 2 months aimed to achieve weight loss and during the second 2 months, weight maintenance. In brief, dietary targets for the HF group were to consume no more than 20 g carbohydrate/day in the first 2 weeks, increasing up to 50 g/day by 8 weeks and continuing thereafter on an amount that maintained initial weight loss. The target for the HP group was to consume 40% of total energy from low glycaemic index carbohydrates, 30% from fat (predominantly unsaturated) and 30% from protein. The HC group were asked to consume at least 55% of total energy from carbohydrates, less than 30% from fat (less than 8% from saturated fat), 15% from protein and to aim for a dietary fibre intake of 25–30 g/day. At the end of 4 months all participants were instructed to continue their allocated diet without supervision until the 6- and 12-month visits. The 93 insulin-resistant women who started the dietary intervention were invited to attend a 12-month follow-up visit even if they had withdrawn earlier from the study. The 12-month follow-up was approved by the local ethics committee and informed consent obtained. Participants were asked to complete a 3-day food diary. Desire to eat and hunger were rated using a 100 mm visual analogue scale before and after the ingestion of breakfast, lunch and dinner over 3 days.23 Mood was measured using a profile of mood state (POMS) self-administered questionnaire (EdITS/Educational and Industrial Testing Service, San Diego, CA, USA).24, 25 Physical activity was estimated using a self-reported Green Prescription Questionnaire recording activity over the past 2 weeks.26 The number of sessions per week and the amount of time spent exercising at each session was recorded. Participants were asked to record their bowel frequency over a 7-day period and a weekly average was recorded. Laxative use was recorded. A questionnaire regarding barriers to diet adherence was administered.

All clinical (weight, waist circumference, blood pressure, fat mass and fat-free mass) and biochemical (fasting lipids, fasting insulin, fasting glucose and 2 h glucose after a 75 g oral glucose tolerance test) measures made at baseline and 2, 4 and 6 months were repeated at 12 months, for which the methodology has been reported.22 Body fat was measured using bioelectrical impedance (IMP5, Impedimed, Australia) following standard procedures.27

Statistical analysis

A difference of 3 kg between the HC diet and either of the other two diets was considered to be of clinical importance. An earlier study indicated that the root mean square error (an estimate of the s.d.) for weight loss, adjusted for baseline, was 4.5 kg.28 This is equivalent to an effect size of 0.66 or 0.70. Two samples of 32 have the potential to detect this difference with 80% power using the 5% level of significance. Based on a random allocation sequence, consecutively numbered envelopes generated in blocks of nine were used to assign participants to each group. There was no stratification. It was not possible to blind researchers or participants, although groups were designated by codes rather than actual names to minimise cross-contamination between the groups.

As data for the intensive first 6 months of the intervention have been previously published, we present here a comparison of the three groups, principally the changes in clinical and biochemical variables between 6 and 12 months and the final outcome of the diets at 12 months. The dietary data are presented as means and s.d. at 12 months.

The data were analysed using two piecewise linear functions with a knot at 6 months. The first function estimated the rate at which the variables of interest changed between 2 and 6 months, and the second the rate of change between 6 and 12 months. These terms and the baseline measure were included in a random effect model, which accounted for the underlying covariance in the data and differences at baseline. As the period between 6 and 12 months is one of the major aspects of this report, results are presented as estimates of change for the second period (95% CI for each treatment). The analysis also compared differences between treatments at 12 months after adjusting for baseline. The results are presented in the text. A log transformation was used for fasting insulin to stabilise the variance (results reported as ratios and 95% CI). Regression analysis was used to estimate differences between each pair of treatments for the dietary data collected at the 12-month assessment. The data were analysed using STATA (StataCorp, Stata Statistical Software, Release 8.0 College Station, TX, Stata Corporation; 2003). A P-value of less than 0.05 is regarded as statistically significant.

Results

Of the 93 participants who started the intervention, 76 (82%) accepted the invitation to return for the 12-month follow-up visit. Of the 16 who did not return, one had moved and could not be contacted and 15 did not wish to return, three due to venous access issues and the remainder citing work and family commitments.

In all, 28 of the 30 (93%) in the HP group returned for the 12-month follow-up, compared with 24 of 31 (77%) in the HF group and 24 of 32 (75%) in the HC group. A Fisher's exact test (P=0.118) showed that the differences in retention rates between groups were not significant. Anthropometric data and selected clinical and laboratory measurements are shown in Figure 1 and Table 1. The HF and HP groups lost a comparable and significantly greater amount of weight and fat mass, and reduced waist circumference compared to the HC group during the first 6 months.22 However, significant increases in weight, fat mass and waist circumference occurred in the HF group between 6 and 12 months (Table 2). The increases in fat mass and waist circumference were significantly greater than that seen in the HP group (Table 2). Overall, the HC group achieved a smaller reduction in weight, fat mass and waist circumference compared to the other groups (Figure 1); however, reductions were sustained between 6 and 12 months (Table 2). Weight at 12 months for all groups was considerably lower compared to baseline (Table 1, and Figure 1) and weight lost was predominantly from fat rather than lean mass. More women in the HP and HF groups had lost more than 10% of initial body weight at 12 months compared to the HC group (36 and 25 versus 4%, respectively, P=0.027) (Figure 2), but the difference between the two alternative diet groups was not significant. When considering the difference between groups in measures of adiposity at 12 months, none achieved statistical significance.

Figure 1
figure1figure1

Adjusted means at each time point for selected clinical and biochemical variables. Black circles=high-carbohydrate (HC) diet; black squares=high-protein (HP) diet; white triangles=high-fat (HF) diet.

Table 1 Means and s.d. for clinical and biochemical variables at baseline, 6 months and 12 monthsa
Table 2 Estimated changes (95% CI) for clinical and metabolic variables in the three dietary groups between 6 and 12 months
Figure 2
figure2

Percentage of participants from each dietary group who lost 5–10% of initial body weight at 12 months and those who lost more than 10% of body weight at 12 months. HC=high-carbohydrate diet; HP=high-protein diet; HF=high-fat diet.

Final 12-month triglyceride levels were not different between the HF and the HC group, but were significantly lower in the HP group, where the mean difference was −0.4 mmol/l (95% CI −0.71, −0.02); P=0.037. Fasting triglycerides significantly increased from 6 to 12 months in the HF group (Figure 1, and Table 2) losing the benefit obtained in the first 6 months. HDL levels at 12 months remained significantly improved in the HF group compared to the HC group, (0.13 mmol/l (0.01, 0.26); P=0.035). Initial improvements in LDL cholesterol seen especially in the HP group were not sustained throughout the 12-month period, so that by 12 months there were no significant differences among the groups (data not presented). Although at 6 months there were more individuals in the HF group who had had a more than 10% increase in LDL levels, by 12 months there was no difference between the groups with five (21%) individuals showing a 10% rise in LDL in the HF group, six (21%) in the HP group and four (17%) in the HC group. No differences were observed in fasting glucose and insulin levels among the groups at 12 months.

Table 3 shows macronutrient intakes calculated from diet records at 12 months together with initial targets. All three dietary groups had strayed considerably from the target macronutrient composition with total and saturated fat intakes higher than target on the HP, carbohydrate intakes substantially higher in the HF group, while those on the HC diet were consuming well below their target intake for total carbohydrate and dietary fibre.

Table 3 Means (s.d.) and [original target compositions] of macronutrient intakes for the three dietary groups at 12 months

Participants in the three diet groups did not report any differences in satiety or hunger between the three diets and reported similar physical activity levels (data not shown). Those on the HF diet had reduced bowel frequency and increased use of anti-constipating medication during the first 6 months, but were not significantly different from the other groups at 12 months. Mood scores were similar for all groups at baseline and 12 months. There were no differences in perceived costs of the three diets.

Discussion

This study compared the two most popular dietary alternatives with the conventional HC–high-fibre approach in a randomised trial over a 12-month period. The findings are relevant to those at high risk of type 2 diabetes and cardiovascular disease since participants were overweight insulin-resistant individuals. The approach used was intended to reproduce what might occur in clinical practice with intensive dietary advice and monitoring provided for the first few months, and participants unsupervised during the following 8-month period. A major strength of this study was the high retention rate compared with other similar studies,6, 17, 19, 20 enabling statistical analysis to be undertaken on an intention to treat basis. Of interest was the remarkably high rate of retention among those in the HP group. Although family and work commitments rather than unacceptability were cited as reasons by those who declined follow-up, it is likely that the higher rate of acceptance by the HP participants indicates a preference for the higher protein dietary regimen.

After 6 months, both alternative diets appeared to have several advantages when compared with the HC diet in high-risk overweight insulin-resistant women: reductions in weight, fat mass, waist circumference and fasting triglycerides were all greater in those on the HP and HF diets than those recommended the conventional diet. HDL levels were higher on HF, but concerns regarding adverse effects of HF diets on fibre intake and LDL levels in some individuals and possibly other cardiovascular risk factors not measured in this study (such as altered thrombogenesis and reduced antioxidant status) precluded endorsement of an HF diet. The 12-month data provide more objective evidence on which to base advice. After 12 months, those on the HC diet had maintained much of the weight lost during the first 6 months, and fasting triglycerides, insulin and waist circumference were all lower than at baseline, although waist circumference increased significantly between 6 and 12 months. Thus several variables associated with IR were improved by this intervention, which is the standard approach to weight reduction in many countries. The modest reduction in LDL cholesterol during the first 6 months was not maintained throughout the period. By 12 months, the macronutrient intakes were nowhere near the initial targets. Total carbohydrate at 45% of total energy was close to the intakes reported for the population as a whole in a recent National Nutrition Survey.29 Total intakes of dietary fibre at 18 g/day was also well below the target of 25–30 g. It is likely that a greater intake of fibre-rich carbohydrate containing foods would have resulted in a greater reduction in fat mass, improvement in clinical and metabolic features of the insulin-resistant syndrome, and especially if saturated fatty acid intakes were further reduced, a reduction in LDL cholesterol.

The only comparable study is that carried out by Dansinger et al.21 They reported similar weight losses in the Atkins, Zone, Weight Watchers and Ornish diets. However, retention rates were lower in the Atkins and Ornish diets (around 50%) and only modestly higher in the Zone and Weight Watchers regimens (65%), compared with our study in which 75–93% completed the 1-year intervention. In the Dansinger et al.21 study, increased dietary adherence, regardless of diet group, was associated with greater weight loss and cardiac risk factor reductions.

Despite the initial improvements in the HF group, during the final 6 months, this group had an increase in waist circumference and fat mass, which was significantly greater than the increase seen in the HC and HP groups. Triglyceride and 2 h glucose levels also increased. Although HDL cholesterol at 12 months was higher on HF than an HC, the deterioration of other important metabolic variables associated with diabetes and cardiovascular risk suggests that a high-fat approach has no overall long-term benefit when compared with the HC conventional approach. These findings are generally compatible with other studies, which have compared the HC approach with the HF diet, although in the studies reported by Foster et al.6 and Stern et al.,17 triglyceride levels were lower than on the HC diets.

In contrast, those following the HP diet appeared to have a particularly favourable outcome. The improvements, which occurred at 6 months, were largely maintained so that at 12 months weight and fat mass were around 6 and 4 kg lower than at baseline. Furthermore, the HP group had significantly more individuals who had lost a clinically meaningful amount of weight than the HC group. The initial improvements in waist circumference, fasting triglyceride and insulin were all maintained. At 12 months, the difference in triglycerides between HP and HC achieved statistical significance; however, the difference in weight (−2.3 kg), fat mass (−1.5 kg) and waist circumference (−3.0 cm) were considerable, but failed to achieve statistical significance (P-values around 0.1) because of wide confidence intervals. At first glance, the findings regarding LDL are surprising. One might have expected the substantial improvements noted during the first 6 months to be maintained. However, the HP group reported intakes of total and saturated fatty acids that were far greater than prescribed and incompatible with optimal levels of total and LDL cholesterol. Limited information is available regarding long-term comparisons between HP and HC diets. Two studies by Brinkworth et al.,19, 20 one in people with type 2 diabetes, the other in obese normoglycaemic individuals, compared HP and conventional diets. They reported no difference between the two diets, but attrition rates were very high. A more recent study by Due et al.18 found greater reductions in abdominal fat and a greater number of participants who had lost 10 kg or more among those on the HP diet than on the conventional diet. They also reported lower attrition rates on the HP.

The similarity in weight at 12 months between all three diet groups is not surprising given that all had strayed considerably from their recommended macronutrient intake. Dietary data at 6 months showed closer adherence to the prescribed diets than were apparent at 12 months.22 At 12 months, women following the HF diet tended to consume more energy, which was reflected in their larger weight gain during months 6–12. As outlined in our earlier report,22 it appears that the greater weight loss often observed on HF or HP diets occurs due to reduced energy intakes rather than any metabolic effect of different macronutrients.

In summary, the conventional high-fibre dietary advice achieved modest but sustained benefits. Further advice with regard to total energy restriction and the most appropriate carbohydrate-containing foods would confer substantial additional benefit. This study provides strong support for the use of higher protein diets as an alternative to the conventional approach. Body weight, fat mass and several major metabolic features of IR were improved in the long term and to the extent that the benefit appeared to be comparable to the change seen on drug therapy.30 Failure to achieve long-term reduction in LDL cholesterol probably reflects insufficient emphasis on the need to reduce saturated fatty acids, and specific dietary advice should reinforce this aspect. There is no evidence for long-term benefit of HF diets such as the Atkins diet. While weight loss and associated metabolic improvements occur during the first 6 months, there is rapid regression of many benefits during the following 6 months, to the extent that at 12 months there are few remaining advantages over and above that achieved on the HC diet. These observations and other potential disadvantages of a high-fat diet such as its thrombogenic potential argue strongly against its use in the long term.

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Acknowledgements

We are grateful to the participants; Glenys Henshaw, the study dietitian; Michelle Harper and Ashley Duncan, who undertook most of the laboratory analyses; Charla Hopkins, who was involved in the first 6 months of this study; and Victoria Farmer for research assistance. Funding was provided by the Health Research Council of New Zealand and in the initial stages of this study financial support was obtained from a Bristol Myers Squibb Mead Johnson Unrestricted Research Grant.

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McAuley, K., Smith, K., Taylor, R. et al. Long-term effects of popular dietary approaches on weight loss and features of insulin resistance. Int J Obes 30, 342–349 (2006). https://doi.org/10.1038/sj.ijo.0803075

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Keywords

  • high-fat diets
  • high-protein diets
  • high-carbohydrate–high-fibre diets
  • weight loss
  • insulin resistance
  • type 2 diabetes

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