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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: LCHF Diet; Other: Exercise; Other: Normal Diet

• Registration Number: NCT04100356
• Lead Sponsor: Atlantis Medical University College

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.

Study Timeline

• Study Start: 2014-01-21
• Primary Completion: 2014-04-04
• Study Completion: 2014-04-23
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
LCHF diet	LCHF Diet	The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat
LCHF diet + exercise	LCHF Diet	The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week.
Normal diet + exercise	Normal Diet	The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week.
LCHF diet + exercise	Exercise	The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week.
Normal diet	Normal Diet	The group ingests normal diet, recommended by the health authorities
Normal diet + exercise	Exercise	The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week.

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC) glucose	Change from baseline AUC glucose at 10 weeks	AUC glucose measured during an OGTT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Norwegian School of Sports Sciences; 🇳🇴 Oslo, Norway