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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100356
• Other study ID #: AMUC-NIH-LCHF-P3-2014
• Status: Completed
• Phase: N/A
• Start date: January 21, 2014
• Est. completion date: April 23, 2014

Study information

• Verified date: November 2020
• Source: Atlantis Medical University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 23, 2014
• Est. primary completion date: April 4, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 33 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Exercise
Exercise program - indoor bicycle interval exercise, duration 60 min 3x week
• Normal Diet
Normal diet recommended by the health authorities
• LCHF Diet
LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates

Locations

Country	Name	City	State
Norway	Norwegian School of Sports Sciences	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Atlantis Medical University College	Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve (AUC) glucose	AUC glucose measured during an OGTT	Change from baseline AUC glucose at 10 weeks
Secondary	Lipid profile	Measurements of total cholesterol, LDL, HDL, TG	Change from Baseline lipids at 10 weeks
Secondary	Body composition	Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass	Change from baseline values at 10 weeks
Secondary	Cardiorespiratory fitness	Measurement of peak oxygen uptake	Change from baseline values at 10 weeks