Clinical trial NCT04100356: The Effect of Exercise and/or Diet on Health Related Parameters
Official title: The Effect of Exercise and/or Diet Body Composition, Cardiorespiratory Fitness and Blood Parameters Related to Improved Health in Overweight Females.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Low-carbohydrate-high-fat diet (LCHF)
Low-density-lipoprotein (LDL)
High-density-lipoprotein (HDL)
Triglycerides (TG)
Lipids
Glucose tolerance (GT)
Insulin resistance (IR)
Body composition
Weight
Lead sponsor: Atlantis Medical University College
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2019-09-24
Enrollment: 57
Sex: FEMALE
Minimum age (years): 33
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Diet and exercise, or diet only
Primary purpose: OTHER

Brief summary: The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise.

Detailed description: Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance.

Exercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. While exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.

We wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.

Eligibility criteria: Inclusion Criteria:

* Women
* Sedentary
* Premenopausal
* Caucasian
* BMI 26.9 - 36.1
* Age 33-4
* Living close to, or in Oslo.

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Smoking or tobacco use
* Previous medical history of cardio-vascular disease (CVD)
* Previous medical history of diabetes
* Previous medical history of endocrine disorder
* Previous medical history of kidney disease
* Use of lipid lowering medication
* Use of diabetes medication

Primary outcomes:
measure: Area under curve (AUC) glucose
timeFrame: Change from baseline AUC glucose at 10 weeks
Secondary outcomes:
measure: Lipid profile
timeFrame: Change from Baseline lipids at 10 weeks
measure: Body composition
timeFrame: Change from baseline values at 10 weeks
measure: Cardiorespiratory fitness
timeFrame: Change from baseline values at 10 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sports Sciences
Study officials:
affiliation: Norwegian School of Sport Sciences, Section of Physical Performance
name: Jørgen Jensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: