Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
Frederiksberg, 1958, Denmark
NCT Number: NCT01622114
Achievement and maintenance of weight loss in obese individuals has proven difficult. Many hypotheses have suggested potential biological mechanisms to explain why weight loss attempts often fail, and the surrounding obesogenic environment also seems an obvious candidate. Among the biological factors proposed is gender, and weight loss trials have frequently shown that females are less successful than males at losing weight and at maintaining weight loss.
Women's weight is influenced by the menstrual cycle, in which changes in hormonal levels and interactions work to modulate fertility. These hormones control the menstrual cycle and coordinate the required changes in energy intake, expenditure, and storage, whilst preparing the body for pregnancy every month. As reproduction is a primary biological function, these hormones may be such strong mediators of eating behavior that they influence the outcome of a weight loss attempt. The menstrual cycle should therefore be taken into consideration as a factor in the physiology of energy balance in premenopausal women.
The cycle can be divided into three phases: menstruation or early follicular phase (days 1-5), late follicular phase that lasts until ovulation (~days 6-14, and the luteal phase (days 15-28).
Studies have shown that in the luteal phase of the menstrual cycle, women's energy intake and energy expenditure are increased and women experience more frequent cravings for foods, particularly those high in carbohydrate and fat, than during the follicular phase. A trend towards reduced carbohydrate utilization and increased fat oxidation in the luteal phase has also been reported, together with prolonged time to exhaustion when exercising at submaximal intensities. This suggests that the potential of the underlying physiology related to each phase of the menstrual cycle may be worth considering as an element in strategies to optimize weight loss.
In 2010 the investigators carried out a 90-day randomized, controlled pilot study in order to gain feedback on and assess acceptance of the meal and exercise plans being used and to observe if less control visits than planed in the main study were sufficient to achieve good compliance. Twenty eight were sreened and 24 were included. Subjects were randomized to either program A (given meal and exercise plans in relation to phases of their menstrual cycles) or Program B (a reduced calorie diet, calorie-matched to program A). The pilot study showed that Group A (The Menstralean group) tended to have a greater average weight loss at 60 days (-5.29 vs -3.57 kg, p = 0.06) and 90 days (-4.22 vs -2.75 kgs, p = 0.2) compared to the control groups. There was a dropout rate of 27%. This was primarily due to an inadequate number of control visits and contact with the subjects. Thus the Menstralean program seems to have the potential to enhance weight loss in overweight and obese women. However, the main study has to be carried out with more subjects in each group in a longer duration and with more support and contact with the subjects.
The aim of the present trial is to examine the impact of the menstrual cycle on weight loss attempts in healthy overweight (BMI > 27 kg/m2) premenopausal women (18-40 years) randomized to two different weight management programs for a period of 6 months.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Frederiksberg, 1958, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2-arm parallel 6 month study with the obejective to examine the impact of the menstrual cycle on weight loss attempts in healthy overweight premenopausal women randomized to two different weight management programs. The women may not use hormonal contraceptive agents other than an IUD.
Time frame: will be measured at baseline and week 2, 4, 8, 12, 16, 20, 24 and at follow up (8 months after initiation)
Assessment of body weight will be carried on a digital scale to the nearest 0.05 kg. The measurement will be carried out after the subjects have emptied their bladder and only wearing underwear.
Time frame: measurement will be carried out at baseline and week 2, 12, 24 and at follow up (8 months after initiation)
Assessment of waist circumference will be carried with a measuring tape to the nearest 0.5 cm. The measurement will be carried out after the subjects have emptied their bladder and only wearing underwear.
Time frame: measurement will be carried out at screening
Height of the subject will measured in a up-right position without shoes to the nearest 0.5 cm.
Time frame: measurement will be carried out at baseline and week 2, 4, 8, 12, 16, 20, 24 and at follow up (8 months after initiation)
BMI is based on the measurement of height and body weight: weight (kg)/ (height (cm)* height (cm))
Time frame: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Quality of life will be assessed by IWQOL-Lite questionnaire at screening, baseline, week 12, week 24 and at follow-up 8 month after initiation of intervention.
Time frame: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
'Impact of Weight on Quality of Life' will be assessed by IWQOL-Lite questionnaire at screening, baseline, week 12, week 24 and at follow-up 8 month after initiation of intervention.
Time frame: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
'Impact of Weight on Quality of Life' will be assessed by FCI-II questionnaire at screening, baseline, week 12, week 24 and at follow-up 8 month after initiation of intervention.
Time frame: measured during the 24-week intervention
University of Copenhagen
Other
Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women - A 6-Month Intervention
Acronym: MENSTRALEAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00687115
Body Weight, Body Weight Changes
Phoenix, Arizona, United States
View Trial DetailsNCT05184361
Body Weight, Body Weight Changes
Cruz Quebrada, Lisbon District, Portugal
View Trial DetailsNCT05424081
Body Weight, Body Weight Changes
Palo Alto, California, United States
View Trial DetailsNCT05104450
Apnea, Behavior
Seattle, Washington, United States
View Trial Details