ObesityMENSTRALEANNCT01622114
Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
A study testing Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females between the ages of 18-40 (inclusive)
- BMI > 27 kg/m².
- Regular menstrual cycle (28 ± 4 days - with a maximum of 4 days within-subject variation in menstrual cycle duration.
- Weight stable (within ± 3-kg) 2 months prior to study inclusion
- Must use barrier contraception (e.g. male/female condom) for the study's duration
- Must be willing to follow the prescribed diet/exercise plan for the study's duration
Who cannot join
- On hormonal contraceptives (IUD are allowed) or any other daily use of medications which can make the subject unsuitable for inclusion in the study.
- Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
- Restrictions against participating in cardiovascular exercise and strength training
- Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
- Women who are pregnant,lactating, or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
Frederiksberg, 1958
About this study
Official title: Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women - A 6-Month Intervention
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
- Keywords
- Obesity, Weight reduction, premenopausal Women, Menstrual cycle, quality of life, food cravings
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal WomenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Menstralean group | Experimental | Represents a program which is designed to induce weight loss by taking into account the physiology of each menstrual phase in terms of adjusting diet and physical activity to the body's cyclic changes in energy demands.
The diet will be adjusted to match one menstrual cycle in duration (approx. 1 month) and will be separated into three phases corresponding to three menstrual phases: menstruation (days 1-5), the follicular phase (days 6-14), and the luteal phase (days 15-28). All women in this group will start the program at day 1 in their cycle. The diet will be repeated six times for each woman, which equals six months. Receives: Other: Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women |
| Control Group: | Active comparator | Represents a program where subjects engage in a similar diet and exercise program as the Menstralean Group, specifically based on the educational diet system "Eat for Life". Importantly, the subjects in Control group will start the program at a random time in their menstrual cycles.
Eat for Life is a simple tool for controlling the energy content and nutritional composition of your diet. The method is based on a system of counters that ensure strict control of the diet whilst still allowing a great deal of freedom of choice. The subjects in the Control Group will also receive exactly the same attention and undergo the same visits and measurements as the Menstralean Group. Receives: Other: Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg)
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.
Measured: will be measured at baseline and week 2, 4, 8, 12, 16, 20, 24 and at follow up (8 months after initiation)
Secondary outcomes (7)
Change in waist circumference (cm)
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.
Measured: measurement will be carried out at baseline and week 2, 12, 24 and at follow up (8 months after initiation)
Height (cm)
Height of the subject will measured in a up-right position without shoes to the nearest 0.5 cm.
Measured: measurement will be carried out at screening
Change in body mass index (BMI)
BMI is based on the measurement of height and body weight: weight (kg)/ (height (cm)* height (cm))
Measured: measurement will be carried out at baseline and week 2, 4, 8, 12, 16, 20, 24 and at follow up (8 months after initiation)
Assessment of Well-being/quality of life
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.
Measured: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Assessment of Impact of Weight on Quality of Life
'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.
Measured: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Assessment of Food cravings
'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.
Measured: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Drop-out rate during the first 24 weeks
Measured: measured during the 24-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, Dr Med, Principal investigator, Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622114
- Sponsor's protocol ID
- B252
- Acronym
- MENSTRALEAN
- Status last verified
- Jan 2016
- First submitted
- 14 Jun 2012
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Geiker NR, Ritz C, Pedersen SD, Larsen TM, Hill JO, Astrup A. A weight-loss program adapted to the menstrual cycle increases weight loss in healthy, overweight, premenopausal women: a 6-mo randomized controlled trial. Am J Clin Nutr. 2016 Jul;104(1):15-20. doi: 10.3945/ajcn.115.126565. Epub 2016 Jun 8.
PubMed 27281304
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women - A 6-Month Intervention
- ClinicalTrials.gov ID
- NCT01622114
- Acronym / sponsor ID
- MENSTRALEAN / B252
- Conditions
- Obesity
- Keywords
- Obesity, Weight reduction, premenopausal Women, Menstrual cycle, quality of life, food cravings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menstralean group | Experimental | Other: Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal WomenRepresents a program which is designed to induce weight loss by taking into account the physiology of each menstrual phase in terms of adjusting diet and physical activity to the body's cyclic changes in energy demands. The diet will be adjusted to match one menstrual cycle in duration (approx. 1 month) and will be separated into three phases corresponding to three menstrual phases: menstruation (days 1-5), the follicular phase (days 6-14), and the luteal phase (days 15-28). All women in this group will start the program at day 1 in their cycle. The diet will be repeated six times for each woman, which equals six months. |
| Control Group: | Active comparator | Other: Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal WomenRepresents a program where subjects engage in a similar diet and exercise program as the Menstralean Group, specifically based on the educational diet system "Eat for Life". Importantly, the subjects in Control group will start the program at a random time in their menstrual cycles. Eat for Life is a simple tool for controlling the energy content and nutritional composition of your diet. The method is based on a system of counters that ensure strict control of the diet whilst still allowing a great deal of freedom of choice. The subjects in the Control Group will also receive exactly the same attention and undergo the same visits and measurements as the Menstralean Group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy females between the ages of 18-40 (inclusive)
- BMI > 27 kg/m².
- Regular menstrual cycle (28 ± 4 days - with a maximum of 4 days within-subject variation in menstrual cycle duration.
- Weight stable (within ± 3-kg) 2 months prior to study inclusion
- Must use barrier contraception (e.g. male/female condom) for the study's duration
Key exclusion criteria (5 listed)
- On hormonal contraceptives (IUD are allowed) or any other daily use of medications which can make the subject unsuitable for inclusion in the study.
- Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
- Restrictions against participating in cardiovascular exercise and strength training
- Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
- Women who are pregnant,lactating, or planning to become pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women2-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. | Other | Control Group:, Menstralean group |
Primary outcome
Change in body weight (kg)
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.
7 secondary outcomes
Change in waist circumference (cm)
Time frame: measurement will be carried out at baseline and week 2, 12, 24 and at follow up (8 months after initiation)
Height (cm)
Time frame: measurement will be carried out at screening
Change in body mass index (BMI)
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)
Assessment of Well-being/quality of life
Time frame: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Assessment of Impact of Weight on Quality of Life
Time frame: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Assessment of Food cravings
Time frame: measurement will be carried out at screening, baseline and week 12 and 24 and after 8 months (follow up)
Drop-out rate during the first 24 weeks
Time frame: measured during the 24-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Derived from this study: PubMed 27281304Geiker NR, Ritz C, Pedersen SD, Larsen TM, Hill JO, Astrup A. A weight-loss program adapted to the menstrual cycle increases weight loss in healthy, overweight, premenopausal women: a 6-mo randomized controlled trial. Am J Clin Nutr. 2016 Jul;104(1):15-20. doi: 10.3945/ajcn.115.126565. Epub 2016 Jun 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Professor, Dr Med principal investigator
Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) (time frame: will be measured at baseline and week 2, 4, 8, 12, 16, 20, 24 and at follow up (8 months after initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.