The Effect of Exercise and/or Diet on Health Related Parameters

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Exercise and/or Diet Body Composition, Cardiorespiratory Fitness and Blood Parameters Related to Improved Health in Overweight Females.

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Exercise
* Other: Normal Diet
* Other: LCHF Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 33 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Diet and exercise, or diet only
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal diet<br>The group ingests normal diet, recommended by the health authorities | Other: Normal Diet<br>* Normal diet recommended by the health authorities<br>|
| Experimental: LCHF diet<br>The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat | Other: LCHF Diet<br>* LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates<br>|
| Experimental: Normal diet + exercise<br>The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week. | Other: Exercise<br>* Exercise program - indoor bicycle interval exercise, duration 60 min 3x week<br>Other: Normal Diet<br>* Normal diet recommended by the health authorities<br>|
| Experimental: LCHF diet + exercise<br>The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week. | Other: Exercise<br>* Exercise program - indoor bicycle interval exercise, duration 60 min 3x week<br>Other: LCHF Diet<br>* LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve (AUC) glucose | AUC glucose measured during an OGTT | Change from baseline AUC glucose at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Measurements of total cholesterol, LDL, HDL, TG | Change from Baseline lipids at 10 weeks | 
| Body composition | Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass | Change from baseline values at 10 weeks | 
| Cardiorespiratory fitness | Measurement of peak oxygen uptake | Change from baseline values at 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipids, Weight, Low-carbohydrate-high-fat diet (LCHF), Low-density-lipoprotein (LDL), High-density-lipoprotein (HDL), Triglycerides (TG), Glucose tolerance (GT), Insulin resistance (IR), Body composition