Women in the Menstralean group commenced their respective programs on the first day of their menstruation; subjects in the control group commenced on a randomly selected and uniformly distributed start date within 28 d. All subjects were instructed in maintaining a diet with a daily energy intake of kcal during the 6-mo study period.
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The Menstralean diet was synchronized to match the menstrual cycle i. The macronutrient composition of the Menstralean diet was aligned to match each of the 3 phases of the menstrual cycle Table 1. The dietary fat content was increased in phase 3 to accommodate the cravings that are often experienced in this phase. Furthermore, a portion of dark chocolate was allowed to be consumed on days 24—28, thereby increasing the daily caloric limit to kcal, also with the aim of satisfying cravings.
Diet and exercise program 1. The control group was instructed to follow a program that was based on the Danish educational, unit-based diet system Kostkalender The Diet Calendar. The system is built around tables that facilitate a simple calculation of the calorie content of foods and meals, thereby controlling total daily energy intake. This method ensured that there was strict control of energy intake while allowing freedom as to choice of foods.
The macronutrient composition of the control diet was persistent throughout the period Table 1. Compliance with the program was evaluated at dietary sessions at weeks 4 and 8. The Menstralean exercise program was also synchronized to the menstrual cycle Table 1. Subjects were advised to pick one light activity each day from a list of exercises e.
Subjects were advised to alternate weight training with cardiovascular workouts in phase 3 with an aim to optimize the higher energy expenditure during this phase.
Body weight was measured after subjects had emptied their bladders and were wearing only underwear at each visit and at follow-up, whereas waist circumference was measured at baseline and at weeks 12 and Height was only measured at baseline. Body weight was measured to the nearest 0. Adverse events were registered throughout the project period. Any ongoing adverse events were followed up by telephone until they were resolved or a clinically stable endpoint was reached. The primary analysis was for the difference in the change in body weight after 24 wk in all randomly assigned subjects, and missing values were imputed via the means of the last observation carried forward [intention-to-treat ITT analysis].
To assess the sensitivity of results to assumptions about patient dropouts, the following 3 additional estimands were considered: 1 adherence throughout the study period [per-protocol PP analysis]; 2 adherence while in the study i. We interpreted these 4 estimands as follows: the current primary ITT analysis evaluated the effectiveness of the intervention as if it were applied at a broader population level under the assumption that the achieved weight loss remained under nonadherence Figure 2A.
In contrast, the 3 sensitivity analyses evaluated varying degrees of efficacy. The PP analysis showed the efficacy in the subpopulation that adhered to the treatment until the very end of the study Figure 2B. The available-case analysis without imputation described the efficacy in the subpopulation that adhered as long as they were comfortable with the treatment and, hence, possibly responded better to the intervention than did the PP population.
Consequently, the longer this subpopulation remained in the study, the stronger the effect could be Figure 3A. Finally, the available-case analysis with imputation prolonged the effects observed until dropout but without allowing any additional subsequent effect modification Figure 3B. A Body weight by available-case analyses without multiple imputation.
B Body weight by available-case analyses with multiple imputation. For all 4 estimands, linear mixed models were fitted. These models contained intervention-time interactions both treated as categorical variables as well as adjustment for age and baseline body weight and BMI as fixed effects next to subjects as random effects. In addition, the serial correlation of repeated measurements within subjects was captured through a spatial Gaussian correlation structure.
Model checking was based on a visual inspection of residual and quantile-quantile plots. The difference in the change in waist circumference after 24 wk was evaluated with the use of an available-case analysis via a similar linear mixed model except that the serial correlation was not modeled.
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Differences in dropouts were evaluated with the use of a chi-square test. Statistical analyses were carried out with the statistical environment R R Foundation for Statistical Computing 13 , in particular with the use of the extension packages lme4, nlme, lsmeans, and multcomp. Baseline characteristics between groups are shown in Table 2. Thirty-one participants completed the wk intervention.
Reasons for dropout are presented in Figure 1. None of the women were excluded because of noncompliance. Baseline characteristics of all randomly assigned participants 1.
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The primary analysis ITT showed a nonclinically significant greater weight loss of 0. The PP analysis showed a more-pronounced weight loss of 4. Similar differences in weight loss were shown for the available case analyses without and with multiple imputation [4. Waist circumference was reduced more in the Menstralean group 2.
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No adverse events were registered during the study. The Menstralean weight-loss program was designed to accommodate changes in dietary preferences and energy expenditure during the menstrual cycle. We were not surprised that the dropout rate was very high in the control group because it has been well established that disappointment by being allocated to a control group and achieving only a modest weight reduction result in a higher attrition in control groups in weight-loss studies.
In short, we showed a clear biological effect of the intervention under varying degrees of adherence, whereas the effectiveness in general clinical practice may be much more limited. In healthy, premenopausal women who are not taking hormonal contraceptives, both energy intake and food preferences have been shown to change because of hormonal fluctuations during the menstrual cycle 3 , 5 — 7 , 10 , Traditional weight-loss programs have generally specified energy intake and the level of physical activity often as a repeating weekly schedule.
Diets that are high in protein have been proven to be more satiating and have been shown to aid weight loss and weight-loss maintenance 15 — High-protein meals increase satiety and fullness and reduce hunger and energy intake in subsequent meals and in the next 24 h 15 , 18 , The protein content of the Menstralean diet was higher than that recommended by both Danish and US public health authorities 20 , It is reasonable to assume that the higher protein content in the Menstralean diet aided the overall adherence to energy restriction through a higher satiating effect as well as by preserving levels of energy expenditure despite the dieting regimen 17 , To assess if the Menstralean diet had an additional effect on weight loss than does a constant high-protein diet, we could have included a third arm in the study in which the proportion of protein was increased but nonchanging through the menstrual phases.
The combination of a higher protein content, especially in the luteal phase, combined with meeting the more frequent and intense cravings for sweet foods by allowing dark chocolate may have increased adherence to the diet and, thus, caused the additional weight loss in the Menstralean group. Limitations of the current study include a high dropout rate, which was highest in the control group. In the Menstralean group, the dropout rate was lower, although it was still quite high for a 6-mo trial, and suggested that the program may have been difficult to follow.
It is challenging to practice 3 alternating dietary and exercise regimens throughout each menstrual cycle in normal daily life. Another limitation of the study is the open-label design, which is unavoidable in dietary intervention trials because they cannot be conducted in a blinded fashion. This design might have created a bias that affected the weight loss ratio. However, the weight loss of 7 kg over 6 mo in the control group was actually better than that generally shown with energy restriction and exercise programs. Subjects in the current study, and in the majority of previous investigations on food and energy intakes during the menstrual cycle, did not use hormonal contraceptives 3 , 5 — 7 , 10 , The evidence of the effect of oral contraceptives on food intake has been contradictory.
The 3 phases of the Menstralean diet were designed to match the mean length of the phases in the menstrual circle. A new confirmatory study might benefit from the inclusion of a higher personalized adaptation to the hormonal flux and menstrual cycle by taking into consideration the high variation in the cycle length between women.
Such a study would have the potential to accommodate dietary preferences and physical exercise capabilities and, thereby, improve adherence, reduce the dropout rate, and even further increase weight loss. In addition, in a confirmatory study, the registration of a care provider i. In conclusion, to the best of our knowledge, this is the first report of a study that has examined the impact of a differentiated diet and exercise weight-loss program that was synchronized with the menstrual cycle in a group of healthy, overweight, premenopausal women.
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Our data provide suggestive evidence that synchronizing dietary composition and exercise with the menstrual cycle can have an additive effect to a traditional diet and exercise program. Sierra Research Group had no influence on the design, implementation, analysis, interpretation, or dissemination of the study. None of the authors reported a conflict of interest related to the study.
Dye L , Blundell J. Menstrual cycle and appetite control: implications for weight regulation. Hum Reprod ; 12 : — Google Scholar. Increased pulsatile, but not basal, growth hormone secretion rates and plasma insulin-like growth factor I levels during the periovulatory interval in normal women. J Clin Endocrinol Metab ; 83 : — 7. Impact of the menstrual cycle on determinants of energy balance: a putative role in weight loss attempts.
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Int J Obes Lond ; 31 : — Food intake and the menstrual cycle: a retrospective analysis, with implications for appetite research. Physiol Behav ; 58 : — Variation in energy intake during the menstrual cycle: implications for food-intake research. Am J Clin Nutr ; 48 : — Energy regulation over the menstrual cycle. Physiol Behav ; 56 : — 7. Pliner P , Fleming AS. Food intake, body weight, and sweetness preferences over the menstrual cycle in humans. Physiol Behav ; 30 : — 6. Relationship between leptin and oestrogens in healthy women. Eur J Endocrinol ; : — All cravings are not created equal.
Correlates of menstrual versus non-cyclic chocolate craving. Weight gain can cause irregular cycles. For most women, weight gain during menstruation is only temporary. Maintaining an overall healthy lifestyle and diet will keep those extra fluctuating pounds from becoming permanent. Skip to main content Skip to footer. Find a Workshop Shop Login. Success Stories. Digital Unlimited Workshops. Stay healthy. Find a Workshop.