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Low Carbohydrate Diet Versus Low Fat Diet in Reversing the Metabolic Syndrome Using NCEP ATP III Criteria

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ClinicalTrials.gov Identifier: NCT04681924
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sherzad Ali Ismael, Hawler Medical University

Brief Summary:

The National Cholesterol Education Program Adult Treatment Panel-III (NCEP ATP III) definition of metabolic syndrome (MetS)is one of the most widely used criteria of metabolic syndrome. It incorporates the key features of hyperglycemia/insulin resistance, visceral obesity, dyslipidemia and hypertension. According to the NCEP ATP III guidelines, in our study, the participants having the metabolic syndrome if they possess three or more of the following criteria: abdominal obesity: Increased waist circumference, Elevated serum triglycerides, Reduced high density lipoprotein cholesterol (HDL), Elevated blood pressure both systolic blood pressure (SBP) and diastolic and Elevated fasting blood glucose.

Although the pathogenesis of MetS is strongly linked to excessive food consumption, in particular fat intake, still there is no consensus about the effects of low carbohydrate diet (LCD) versus low fat diet (LFD) on reversing the MetS and on its metabolic risk factors. However, concerns have been raised with regard to the macronutrient shift with high carbohydrate restriction and the substantial intakes of fats, which may present unfavorable effects on cardiovascular disease risk factors. Meanwhile the LFD has generally been supported by studies to have beneficial effects on these risk factors.

There is no consensus about the effects of LCD versus LFD on the metabolic syndrome. This study investigated the effects of LCD versus LFD on the obese peoples and followed up them for 6 months. Out of 289 obese adults apparently healthy were randomly chosen by a stratified multistage probability sampling method, 94 of them are agreed to participate in the study. They were assigned randomly into low carbohydrate and low-fat diet groups. Both groups were followed up for 6 months and the data were taken at baseline, after 3 months and 6 months of intervention. Ninety-four obese participants completed the intervention.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Diet intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Low carbohydrate diet group received low carbohydrate food versus low fat diet group who received low fat food. Eight hundred adults (≥18year old) of both gender (358 males and 442 females) are surveyed in the 12 population clusters in Erbil city to estimate the prevalence of MetS. The population frame of household of Erbil population based on all 12 offices of Family ID card in Erbil city. The randomized cluster sampling survey method of the houses is used for sample selection. Out of 289 obese adult participants who had the inclusion criteria to participate in the study, only 94 of them agreed to participate in the intervention (23 males and 71 females). Those 94 are randomly assigned into two groups, the LCD (n=54) and LFD (n=40) group. All the adult participants are completed a comprehensive medical examination and routine blood tests
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Low Carbohydrate Diet Compared to Low Fat Diet in Reversing the Metabolic Syndrome Using NCEP ATP III Criteria; Randomized Clinical Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low carb diet
Low carb diet (n=54)
Other: Diet intervention
Low carb diet group are compared to low fat diet group and followed up for 6 months
Other Name: LCD vs LFD

Experimental: Low fat diet
Low fat diet (n=40)
Other: Diet intervention
Low carb diet group are compared to low fat diet group and followed up for 6 months
Other Name: LCD vs LFD




Primary Outcome Measures :
  1. Prevalence of metabolic syndrome [ Time Frame: Baseline ]

    The number of participants in the sample with the criteria of metabolic syndrome, divided by the total number of participants in the sample.

    According to the NCEP ATP III guidelines, the participants having the metabolic syndrome if they possess three or more of the following criteria: Abdominal obesity, elevated triglycerides, reduced HDL, elevated blood pressure and elevated fasting glucose.


  2. Change from baseline in metabolic syndrome and at 6 months [ Time Frame: 6 months ]
    Data on baseline characteristics of adult participants were expressed as means ± SD and/ or frequencies and percentage. The data checked for normal distribution by Shapiro-Wilk test; the p-value was 0.10 which indicates that the data was normally distributed. The study used t tests and Chi square test of association to compare baseline characteristics between both diet programs. An independent samples t-test was used to compare the means of a normally distributed metabolic risk factors for both independent diet programs at the baseline and after 6 months of intervention.

  3. Compare prevalence of metabolic syndrome in both diet programs [ Time Frame: 6 months ]
    A two-way repeated measures ANOVA was used to compare differences of metabolic dependent variables between the two independent variables, the LCD & LFD, at baseline, after 3 months and after 6 months. To determine how much of an effect of intervention has had on the participants, the study used the following cut-offs to interpret the results: 0.14 or more are large effects, 0.06 are medium effects and 0.01 are small effects.


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: Baseline ]
    The formula used for calculating body mass index (BMI) was as following: BMI=weight(kg)/height(m2)

  2. Change from baseline in abdominal obesity and at 6 months [ Time Frame: 6 months ]
    Waist circumference in cm was measured midway above umbilical. Abdominal obesity by increased waist circumference (in men: >= 102 cm while in women: >= 88 cm).

  3. Change from baseline in elevated triglycerides and at 6 months [ Time Frame: 6 months ]
    Blood samples for lipid profile as as mg/ dL were obtained after participants fasted overnight (8-10 hours). The serum analyzed by the(BIOTECNICA BT4500 Full Automated Chemistry Analyser, 2016). Elevated triglycerides if it was >= 150 mg/dL).

  4. Change from baseline in reduced HDL and at 6 months [ Time Frame: 6 months ]
    Blood samples for lipid profile as as mg/ dL were obtained after participants fasted overnight (8-10 hours). The serum analyzed by the(BIOTECNICA BT4500 Full Automated Chemistry Analyser, 2016). Reduced HDL if it was in men: < 40 mg/dL while in women: < 50 mg/dL).

  5. Change from baseline in elevated blood pressure and at 6 months [ Time Frame: 6 months ]
    Blood pressure as mmHg was measured using an MDF Desk Mercury Sphygmomanometer (Model No:MDF 800). elevated blood pressure if it was >= 130/85 mm Hg.

  6. Change from baseline in elevated fasting glucose and at 6 months [ Time Frame: 6 months ]
    Blood samples for blood glucose as as mg/ dL were obtained after participants fasted overnight (8-10 hours). The serum analyzed by the(BIOTECNICA BT4500 Full Automated Chemistry Analyser, 2016).Elevated fasting glucose if it was >= 100 mg/dL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All adult obese participants
  2. Had 3 or more of the following criteria of metabolic syndrome according to the NCEP

ATP III guidelines:

  • Abdominal obesity: increased waist circumference
  • Elevated triglycerides
  • Reduced HDL
  • Elevated blood pressure
  • Elevated fasting glucose

Exclusion Criteria:

  1. Individuals with history or diagnosed with diseases and health related issues like:

    • Diabetes mellitus
    • Hypertension
    • Chronic skin disease
    • Heart disease
    • Hyperlipidemia
    • Malignant disease
    • Rheumatoid arthritis
  2. Those who had undergone surgery during one month before the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681924


Sponsors and Collaborators
Hawler Medical University
Investigators
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Study Director: Ali A Al-Dabbagh, Prof. Hawler Medical University
Additional Information:
Publications of Results:
Organization WH. STEPS instruments for NCD risk factors (core and expanded version 1.4): the WHO STEPwise approach to Surveillance of noncommunicable diseases (STEPS). 2001

Other Publications:
Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sherzad Ali Ismael, Assistant Professor Dr. Sherzad Ali Ismael, Hawler Medical University
ClinicalTrials.gov Identifier: NCT04681924    
Other Study ID Numbers: 6122342016
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases