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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Normal Diet
LCHF Diet
Sponsored by
Atlantis Medical University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Low-carbohydrate-high-fat diet (LCHF), Low-density-lipoprotein (LDL), High-density-lipoprotein (HDL), Triglycerides (TG), Lipids, Glucose tolerance (GT), Insulin resistance (IR), Body composition, Weight

Eligibility Criteria

33 Years - 47 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Norwegian School of Sports Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Normal diet

LCHF diet

Normal diet + exercise

LCHF diet + exercise

Arm Description

The group ingests normal diet, recommended by the health authorities

The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat

The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week.

The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week.

Outcomes

Primary Outcome Measures

Area under curve (AUC) glucose
AUC glucose measured during an OGTT

Secondary Outcome Measures

Lipid profile
Measurements of total cholesterol, LDL, HDL, TG
Body composition
Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass
Cardiorespiratory fitness
Measurement of peak oxygen uptake

Full Information

First Posted
September 13, 2019
Last Updated
November 26, 2020
Sponsor
Atlantis Medical University College
Collaborators
Norwegian School of Sport Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04100356
Brief Title
The Effect of Exercise and/or Diet on Health Related Parameters
Official Title
The Effect of Exercise and/or Diet Body Composition, Cardiorespiratory Fitness and Blood Parameters Related to Improved Health in Overweight Females.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 21, 2014 (Actual)
Primary Completion Date
April 4, 2014 (Actual)
Study Completion Date
April 23, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantis Medical University College
Collaborators
Norwegian School of Sport Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Low-carbohydrate-high-fat diet (LCHF), Low-density-lipoprotein (LDL), High-density-lipoprotein (HDL), Triglycerides (TG), Lipids, Glucose tolerance (GT), Insulin resistance (IR), Body composition, Weight

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Diet and exercise, or diet only
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal diet
Arm Type
Experimental
Arm Description
The group ingests normal diet, recommended by the health authorities
Arm Title
LCHF diet
Arm Type
Experimental
Arm Description
The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat
Arm Title
Normal diet + exercise
Arm Type
Experimental
Arm Description
The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week.
Arm Title
LCHF diet + exercise
Arm Type
Experimental
Arm Description
The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise program - indoor bicycle interval exercise, duration 60 min 3x week
Intervention Type
Other
Intervention Name(s)
Normal Diet
Intervention Description
Normal diet recommended by the health authorities
Intervention Type
Other
Intervention Name(s)
LCHF Diet
Intervention Description
LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates
Primary Outcome Measure Information:
Title
Area under curve (AUC) glucose
Description
AUC glucose measured during an OGTT
Time Frame
Change from baseline AUC glucose at 10 weeks
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Measurements of total cholesterol, LDL, HDL, TG
Time Frame
Change from Baseline lipids at 10 weeks
Title
Body composition
Description
Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass
Time Frame
Change from baseline values at 10 weeks
Title
Cardiorespiratory fitness
Description
Measurement of peak oxygen uptake
Time Frame
Change from baseline values at 10 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Premenopausal
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen Jensen, Professor
Organizational Affiliation
Norwegian School of Sport Sciences, Section of Physical Performance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian School of Sports Sciences
City
Oslo
ZIP/Postal Code
0863
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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