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NCT Number: NCT04100356

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

33 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sports Sciences

Oslo, 0863, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Exercise program - indoor bicycle interval exercise, duration 60 min 3x week

Normal Diet

Other

Normal diet recommended by the health authorities

LCHF diet

Other

LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates

Primary outcomes

  1. Area under curve (AUC) glucose

    Time frame: Change from baseline AUC glucose at 10 weeks

    AUC glucose measured during an OGTT

Secondary outcomes

  1. Lipid profile

    Time frame: Change from Baseline lipids at 10 weeks

    Measurements of total cholesterol, LDL, HDL, TG

  2. Body composition

    Time frame: Change from baseline values at 10 weeks

    Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass

  3. Cardiorespiratory fitness

    Time frame: Change from baseline values at 10 weeks

    Measurement of peak oxygen uptake

Sponsors and collaborators

Lead sponsor

Atlantis Medical University College

Other

Collaborators

  • Norwegian School of Sport Sciences

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2019
Registry last updated
Nov 30, 2020

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.

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