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

NCT04681924 | Completed

• 1 other identifier: 6122342016
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• Prevalence of metabolic syndrome

  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.

  Baseline

• Change from baseline in metabolic syndrome and at 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.

  6 months

• Compare prevalence of metabolic syndrome in both diet programs

  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.

  6 months

Secondary Outcomes (6)

• Body mass index

  Baseline

• Change from baseline in abdominal obesity and at 6 months

  6 months

• Change from baseline in elevated triglycerides and at 6 months

  6 months

• Change from baseline in reduced HDL and at 6 months

  6 months

• Change from baseline in elevated blood pressure and at 6 months

  6 months

Study Arms (2)

Low carb diet

EXPERIMENTAL

Low carb diet (n=54)

Other: Diet intervention

Low fat diet

EXPERIMENTAL

Low fat diet (n=40)

Other: Diet intervention

Interventions

Diet intervention OTHER

Low carb diet group are compared to low fat diet group and followed up for 6 months

Also known as: LCD vs LFD

Low carb diet; Low fat diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult obese participants
• 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

You may not qualify if:

• 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
• Those who had undergone surgery during one month before the study

Sponsors & Collaborators

• Hawler Medical University: lead

Related Publications (23)

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  RESULT

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• Ismael SA. Effects of low carbohydrate diet compared to low fat diet on reversing the metabolic syndrome, using NCEP ATP III criteria: a randomized clinical trial. BMC Nutr. 2021 Nov 3;7(1):62. doi: 10.1186/s40795-021-00466-8.

  PMID: 34727975 DERIVED

Related Links

• STEPS Instrument for NCD Risk Factors (Core and Expanded Version 1.4)

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ali A Al-Dabbagh, Prof.

  Hawler Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr. Sherzad Ali Ismael

Model Details: 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

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: July 3, 2017
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share