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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Normal Diet; Other: LCHF Diet; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0863
    • Norwegian School of Sports Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Atlantis Medical University College
• Collaborators: Norwegian School of Sport Sciences
• Investigators: Principal Investigator: Jørgen Jensen, Professor, Norwegian School of Sport Sciences, Section of Physical Performance

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2014
• Primary Completion (Actual): April 4, 2014
• Study Completion (Actual): April 23, 2014

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Body composition; Lipids; Insulin resistance (IR); Weight; Low-carbohydrate-high-fat diet (LCHF); Low-density-lipoprotein (LDL); High-density-lipoprotein (HDL); Triglycerides (TG); Glucose tolerance (GT)
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: AMUC-NIH-LCHF-P3-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No