"Improving Diet, Exercise And Lifestyle (IDEAL) for Women" Study

/Home/Complications of Diabetes/Diabetes and Sexual Problems/Clinical Trials for Diabetes and Sexual Problems

"Improving Diet, Exercise And Lifestyle (IDEAL) for Women" Study
This study is currently recruiting participants.
Verified by McMaster University, December 2008
Sponsors and Collaborators: McMaster University
The Dairy Farmers of Canada
Dairy Management Inc.
Hamilton Health Sciences

Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00710398

Purpose
Diets all share the same principle: eat less energy than you need. This results in weight loss. However, the weight loss is usually a combination of a loss of body fat and muscle mass. Additionally, one's bones may begin to weaken, albeit very slowly, while on a diet, which could have serious long-term consequences. Thus, the investigators believe that the goal of any weight loss strategy should be to lose body fat and spare muscle. The investigators reasoning is two-fold. 1) Fat is stored not only under our skin, but also sometimes in and around our internal organs. When this occurs, the organ itself may not function properly. Losing fat mass is a very good thing from a health standpoint since fat is not just a storage site for extra energy. Scientists have now shown that the 'extra' body fat itself can actually secrete substances that when they get into your blood cause many problems and may even contribute to the development of diabetes. 2) Sparing muscle as the investigators lose weight is very important. Muscle is a very 'metabolically active' tissue and is, by analogy, like the body's furnace. Muscle burns fuels from the food the investigators eat but also from stored fuels, like fat. Hence, it's easy to see why you don't want to lose muscle because you'd be losing one of your body's best fat burners. Importantly, muscle is also a big storage site and furnace for blood sugar. In people with diabetes (elevated blood sugar) a big part of the problem is with their muscles - they simply do not take up and store or burn enough sugar. So it's easy to see why you want to lose fat on a diet, while preserving your muscle.

There are many different diets to choose from (e.g. high protein, low carbohydrate, high fat, high fiber, etc.). A diet that has been shown to be quite successful, however, is one that is higher in protein (but not excessive), and high in calcium, particularly in people who are low calcium consumers. In most peoples' daily diet, calcium comes, for the most part, from dairy sources (milk, yogurt, cheese). Thus, in this study, the investigators are proposing to test whether a higher protein and calcium diet promotes body fat loss and muscle mass retention. The investigators believe that a diet higher in protein, most coming from dairy protein, but still within accepted healthy ranges, with higher calcium will result in greater loss of body fat and retention of muscle than a diet with only higher calcium or a regular diet with little calcium. Based on previous research, the investigators think that people with low calcium intakes to begin with would stand to benefit the most. There is also a good reason to think that the high protein/high calcium diet will result in greater reductions in blood cholesterol and blood sugar, both of which would reduce a person's risk for heart disease and diabetes.

The investigators will test our diet in premenopausal (19-45) women who are overweight or obese. The investigators believe that this group is a good one to target for several reasons. First, women of this age who are overweight or obese are, if they continue to carry this excess weight, at serious risk for developing chronic diseases such as, heart disease, diabetes, and possibly cancer at an early age. Second, these women will often begin to gradually consume less dairy because many perceive dairy foods as fattening. Thus, if our proposals are correct then the investigators will be able to equip health professionals with a tried and tested, and very palatable, diet in a population segment who, because of their age, would benefit greatly were their disease risk to be reduced.



Condition Intervention
Overweight
Obesity
Behavioral: Exercise - Aerobic and Resistance
Behavioral: Dietary - Caloric Restriction




MedlinePlus related topics: Calcium Dietary Proteins Exercise and Physical Fitness Menopause Obesity Weight Control
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:The Impact of Higher Dairy and Dietary Protein on the "Quality" of Hypoenergetic Diet-and Exercise-Induced Weight Loss in Pre-Menopausal, Overweight and Obese Young Women

Further study details as provided by McMaster University:

Primary Outcome Measures:
Fat mass, lean mass, bone mass (BMD, BMC), total mass (measured via DXA scan) [ Time Frame: Measured at weeks 0, 8 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Blood sample analyses (lipids, glucose, insulin, A1c) [ Time Frame: Measured at weeks 0, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]

Muscle and adipose tissue biopsies [ Time Frame: Measured at weeks 0 and 16 ] [ Designated as safety issue: No ]

Food record macronutrient and micronutrient analyses (7-day at beginning and end, and 2-day throughout intervention) [ Time Frame: Biweekly from weeks 0-16 ] [ Designated as safety issue: No ]

Resting Energy Expenditure (metabolic cart determination). [ Time Frame: Measured at weeks 0 and 16 ] [ Designated as safety issue: No ]

Fitness and strength measures (modified Astrand Test and 1 RM test) [ Time Frame: Measured at weeks 0 and 16 ] [ Designated as safety issue: No ]

Blood sample analyses (Vitamin D [25OHD] and PTH) [ Time Frame: Measured at weeks 0 and 16 ] [ Designated as safety issue: No ]

Magnetic Resonance Imaging (MRI) *strictly on a voluntary basis [ Time Frame: Measured at weeks 0 and 16 ] [ Designated as safety issue: No ]

Spot Urine Collection [ Time Frame: Measured at weeks 0 and 16 ] [ Designated as safety issue: No ]

Body Image (Assessed via a validated questionnaire) [ Time Frame: Measured at weeks 0, 8 and 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:75
Study Start Date:July 2008
Estimated Study Completion Date:December 2009
Estimated Primary Completion Date:December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Control: Experimental
A group consuming twice daily (post-exercise and in morning/afternoon) drinks containing no dairy protein or calcium. Daily protein intake (15% total kcals) should be from non-dairy sources (i.e. meat, egg, fish, chicken, wheat gluten). Behavioral: Exercise - Aerobic and Resistance
Subjects will perform exercise (aerobic and resistance) 7d/wk and will exercise supervised 5d/wk. Exercise will be carried out to expend 250 kcals/day. Supervised resistance training sessions will take place 2 days/wk and aerobic exercise will take place every day. During the resistance exercise sessions, subjects will engage in a circuit weightlifting routine using guided motion machines. During the aerobic sessions, subjects may choose whatever exercise modality they like (e.g. walking on track or treadmill, biking, elliptical, etc.). Subjects will wear devices that measure energy expenditure to get a better idea of the intensity and duration needed to expend 250 kcals with their exercise machine/modality of choice.
Behavioral: Dietary - Caloric Restriction
Subjects will be counselled on their respective hypocaloric diet to follow for the 16 wk period. Adherence to the prescribed diet will be assessed via collection of assigned food records (biweekly), frequent contact with subjects, and regular dietary counseling sessions. The daily dietary energy deficit will be 500 kcal per day based on the subjects' estimated basal energy requirements (based on height, weight, age, sex), multiplied by a sedentary activity factor.

Additionally, subjects will consume 2 drinks per day that will differ depending on their randomization allocation. Subjects in the Dairy Protein and High Dairy Protein group will be provided with dairy products (e.g. milk, cheese, yogurt) to consume on a weekly basis to help facilitate their prescribed dairy and dietary protein intake.

Dairy Protein: Experimental
A group consuming twice daily drinks (post-exercise and morning) of 1% chocolate milk (in 1.5 cup servings = 3 cups/d). 1.5 cups ('1 drink') contains ~375 mg of calcium, ~135 IU of vitamin D, 40.5 g carbohydrate, and 10.5 g of protein. Daily protein intake is set at 15% total kcals with ~8% coming from dairy sources. Behavioral: Exercise - Aerobic and Resistance
Subjects will perform exercise (aerobic and resistance) 7d/wk and will exercise supervised 5d/wk. Exercise will be carried out to expend 250 kcals/day. Supervised resistance training sessions will take place 2 days/wk and aerobic exercise will take place every day. During the resistance exercise sessions, subjects will engage in a circuit weightlifting routine using guided motion machines. During the aerobic sessions, subjects may choose whatever exercise modality they like (e.g. walking on track or treadmill, biking, elliptical, etc.). Subjects will wear devices that measure energy expenditure to get a better idea of the intensity and duration needed to expend 250 kcals with their exercise machine/modality of choice.
Behavioral: Dietary - Caloric Restriction
Subjects will be counselled on their respective hypocaloric diet to follow for the 16 wk period. Adherence to the prescribed diet will be assessed via collection of assigned food records (biweekly), frequent contact with subjects, and regular dietary counseling sessions. The daily dietary energy deficit will be 500 kcal per day based on the subjects' estimated basal energy requirements (based on height, weight, age, sex), multiplied by a sedentary activity factor.

Additionally, subjects will consume 2 drinks per day that will differ depending on their randomization allocation. Subjects in the Dairy Protein and High Dairy Protein group will be provided with dairy products (e.g. milk, cheese, yogurt) to consume on a weekly basis to help facilitate their prescribed dairy and dietary protein intake.

High Dairy Protein: Experimental
A group consuming twice daily drinks of 1% artificially sweetened chocolate milk (in 1.5 cup servings = 3 cups/d). 1.5 cups ('1 drink') contains ~375 mg of calcium, ~135 IU of vitamin D, 19.5 g carbohydrate, and 10.5 g of protein. Their diet contains 30% protein (as opposed to only 15% in the Con and DairyPro groups) with at least 50% of that coming from dairy sources. Behavioral: Exercise - Aerobic and Resistance
Subjects will perform exercise (aerobic and resistance) 7d/wk and will exercise supervised 5d/wk. Exercise will be carried out to expend 250 kcals/day. Supervised resistance training sessions will take place 2 days/wk and aerobic exercise will take place every day. During the resistance exercise sessions, subjects will engage in a circuit weightlifting routine using guided motion machines. During the aerobic sessions, subjects may choose whatever exercise modality they like (e.g. walking on track or treadmill, biking, elliptical, etc.). Subjects will wear devices that measure energy expenditure to get a better idea of the intensity and duration needed to expend 250 kcals with their exercise machine/modality of choice.
Behavioral: Dietary - Caloric Restriction
Subjects will be counselled on their respective hypocaloric diet to follow for the 16 wk period. Adherence to the prescribed diet will be assessed via collection of assigned food records (biweekly), frequent contact with subjects, and regular dietary counseling sessions. The daily dietary energy deficit will be 500 kcal per day based on the subjects' estimated basal energy requirements (based on height, weight, age, sex), multiplied by a sedentary activity factor.

Additionally, subjects will consume 2 drinks per day that will differ depending on their randomization allocation. Subjects in the Dairy Protein and High Dairy Protein group will be provided with dairy products (e.g. milk, cheese, yogurt) to consume on a weekly basis to help facilitate their prescribed dairy and dietary protein intake.

Eligibility
Ages Eligible for Study:19 Years to 45 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:Yes
Criteria
Inclusion Criteria:

Healthy pre-menopausal female
Body Mass Index (BMI) between 27-40 kg/m2
Low dairy consumption (~<500 mg/d Ca2+)
Sedentary lifestyle (i.e., exercise less than once/week)
Regular menstrual cycle
Exclusion Criteria:

Allergy to dairy protein
Lactose intolerance
Vegan diet
Pregnant
Taking vitamin or mineral supplements
Have a gastrointestinal disease or condition
Diagnosed with heart, kidney, liver or pancreatic disease
Smoker
Alcohol consumption of more than 2 drinks/day
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710398

Contacts
Contact: Stuart M. Phillips, Ph.D. 905-525-9140 ext 24465 phillis@mcmaster.ca
Contact: Andrea R. Josse, M.Sc. 905-525-9140 ext 27384 jossea@mcmaster.ca

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S4K1
Contact: Stuart M Phillips, Ph.D. 905-525-9140 ext 24465 phillis@mcmaster.ca
Contact: Andrea R Josse, M.Sc. 905-525-9140 ext 27384 jossea@mcmaster.ca
Principal Investigator: Stuart M. Phillips, Ph.D.
Sub-Investigator: Andrea R. Josse, M.Sc.
Sub-Investigator: Mark A. Tarnopolsky, MD, Ph.D.
Sub-Investigator: Stephanie Atkinson, Ph.D.

Sponsors and Collaborators
McMaster University
The Dairy Farmers of Canada
Dairy Management Inc.
Hamilton Health Sciences
Investigators
Principal Investigator: Stuart M Phillips, Ph.D. Department of Kinesiology, McMaster University
Study Director: Andrea R Josse, M.Sc. Department of Kinesiology, McMaster University

Responsible Party:McMaster University ( Dr. Stuart M. Phillips )
Study ID Numbers:REB 07-409
First Received:July 1, 2008
Last Updated:December 8, 2008
ClinicalTrials.gov Identifier:NCT00710398 [history]
Health Authority:Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by McMaster University:
Dairy Products
Dietary Protein
Body Composition
Fat mass loss
Lean mass gain
Pre-menopausal Women

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Nutrition Disorders
Overnutrition
Overweight
Menopause