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Metabolic SyndromeNCT04681924

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

A study testing Diet intervention in people with Metabolic Syndrome, run by Hawler Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome
What is being tested?
Diet intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 3 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Individuals with history or diagnosed with diseases and health related issues like:
  • Diabetes mellitus
  • Hypertension
  • Chronic skin disease
  • Heart disease
  • Hyperlipidemia
Show all 9Show fewer
  • Malignant disease
  • Rheumatoid arthritis
  • Those who had undergone surgery during one month before the study

About this study

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

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.

Read the detailed description

The metabolic syndrome (MetS) is a major and escalating public health and clinical challenge worldwide in the wake of urbanization, excess energy intake, increasing obesity, and sedentary life style. Metabolic syndrome a five-fold increasing the risk of type 2 diabetes mellitus (T2DM) and two fold increasing the risk of developing cardiovascular disease (CVD) over the next 5 to 10 years. Worldwide prevalence of MetS ranges from <10% to as much as 84%, depending on the region, urban or rural environment, population composition (sex, age, race, and ethnicity), and the definition of the syndrome used. The NCEP ATP III definition is one of the most widely used criteria of metabolic syndrome. It incorporates the key features of hyperglycaemia/insulin resistance, visceral obesity, dyslipidaemia and hypertension.

The treatment of metabolic syndrome intends to improve insulin sensitivity and correct the associated metabolic and cardiovascular abnormalities. During the past few years, several studies have evaluated the health effects of low carbohydrate-high protein diet (LCD), with emphasis on cardiovascular diseases versus low fat diet (LFD). Low-carbohydrate diet has become a popular strategy for weight loss and weight management in recent years. In addition, data from several randomized trials have demonstrated that LCD produced greater effects on weight loss and reducing cardiovascular and metabolic risk factors than LFD. A popular version of this LCD recommends extreme restriction of carbohydrate intake to less than 20 gram/day initially.

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 LCD versus LFD on reversing the MetS and on its metabolic risk factors. However, concerns have been raised with regard to the macronutrient shift with high CHO restriction and the substantial intakes of fats, which may present unfavorable effects on CVD risk factors. Meanwhile the LFD has generally been supported by studies to have beneficial effects on these risk factors.

The purpose of this study was to investigate the effects of a low carb diet compared to low fat diet on reversing and treating metabolic syndrome and their risk factors among a sample of obese adults in Erbil city/ Iraq Kurdistan.

This study is a randomized clinical trial conducted over 6 months, between (January and June 2017) with outcome assessments at baseline, at 3, and 6 months of intervention.

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.

A modified questionnaire of world health organization (WHO) STEPwise approach to Surveillance of noncommunicable diseases (STEPS) was used in this study. The modified questionnaire included 25 questions on socio-demographic (9 questions), anthropometric measurements (7 questions) and biochemical measurements (9 questions).

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 is written in the following: Abdominal obesity: Increased waist circumference Men: > 102 cm, Women: > 88 cm, Elevated triglycerides > 150 mg/dL, Reduced HDL Men: < 40 mg/dL, Women: < 50 mg/dL, Elevated blood pressure > 130/85 mm Hg \& Elevated fasting glucose > 100 mg/dL.

Individuals with history or diagnosed with diseases and health related issues like diabetes mellitus, hypertension, chronic skin disease, heart disease, hyperlipidemia, malignant disease, and rheumatoid arthritis and those who had undergone surgery during one month before the study are excluded in the study.

More than half of the participants (n = 54) were followed the LCD. In this diet program, the primary behavioral target was to limit carbohydrate intake. Therefore, the limited carbohydrate intake and unrestricted consumption of fat and protein are allowed. During the first two weeks of the intervention, participants were instructed to limit carbohydrate intake to 20-gram per day. After the first two weeks, the participants were instructed to gradually increase 5-gram of the carbohydrate intake every week.

Forty participants were followed the LFD. The primary behavioral target was to limit the overall energy intake (1200 kcal/d). They received instructions to increase calorie intake from 1200 to 1800 kcal per day (≤ 30% of calories from fat, <7% saturated fat).

All 94 participants completed the 6 months of intervention. They were followed up regularly by direct interview every two weeks by the researcher. Each follow-up session lasted 15 to 30 minutes. All of them were prescribed the same level of instruction concerning drinking 10-12 glasses of water /day and physical activity (principally walking), beginning at week 2, with 1 session of 30-45 minutes per day then increasing the duration of physical activity to reach at least 60 minutes /day.

An electronic weight scale (model 770: Seca, Germany) was used to measure the participants' weight to the nearest 0.1 kg. While the participants were asked to stand still without shoes, a measuring tape was utilized to measure their lightly clothed height to the nearest 0.5 cm. The formula used for calculating body mass index (BMI) was as following: BMI=weight(kg)/height(m2). The measurements were collected at baseline, at 3 months and 6 months.

Waist circumference (WC) was measured midway above umbilical between the distal border of the lowest rib and the superior border of the iliac crest at the end of a normal expiration. Measurements were done with the subject in upright position, without clothes, both feet touching the ground, and arms hanging freely. A non-elastic tape measure was placed directly on the skin on the waist line without putting pressure on the abdominal wall.

Blood pressure (BP) was measured by the researcher using an MDF Desk Mercury Sphygmomanometer (Model No: MDF 800), with cuff sizes based on measured arm circumference. Blood pressure checked after participants were asked to sit and take rest for 10 minutes. The measurements were collected at baseline, at 12 and 24 weeks.

Blood samples were obtained after participants fasted overnight (8-10 hours). Blood sample analyzed in the laboratory department of one of the two main hospitals in Erbil city, the Rzgary Teaching Hospital. The serum analyzed by the same laboratory and by the same device (BIOTECNICA BT4500 Full Automated Chemistry Analyser, 2016).

The adherence of the diet programs was done based on participants' self-reporting. Also, delivery of the intervention and assessment of the outcomes are not blinded.

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. When the expected count more than 20% of the cells of the table was less than 5, Fisher exact test was used. 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. 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. A p-value of ≤0.05 was considered as the level of significance for all analyses. The Statistical Package for the Social Sciences (SPSS) software, version 22 was used for data analysis.

Being tested
Diet intervention
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet interventionOther

    Also called LCD vs LFD

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

Study groups in NCT04681924
Study groupRoleWhat they receive
Low carb dietExperimentalLow carb diet (n=54)
Receives: Other: Diet intervention
Low fat dietExperimentalLow fat diet (n=40)
Receives: Other: Diet intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Secondary outcomes (6)
  1. Body mass index

    The formula used for calculating body mass index (BMI) was as following: BMI=weight(kg)/height(m2)

    Measured: Baseline

  2. Change from baseline in abdominal obesity and at 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).

    Measured: 6 months

  3. Change from baseline in elevated triglycerides and at 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).

    Measured: 6 months

  4. Change from baseline in reduced HDL and at 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).

    Measured: 6 months

  5. Change from baseline in elevated blood pressure and at 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.

    Measured: 6 months

  6. Change from baseline in elevated fasting glucose and at 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start1 Jan 2017
  3. Primary completion1 Jun 2017
  4. Study completion3 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681924
Sponsor's protocol ID
6122342016
Status last verified
Dec 2020
First submitted
12 Oct 2020
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 19805654
  • Kaur J. A comprehensive review on metabolic syndrome. Cardiol Res Pract. 2014;2014:943162. doi: 10.1155/2014/943162. Epub 2014 Mar 11.

    PubMed 24711954
  • Huang PL. A comprehensive definition for metabolic syndrome. Dis Model Mech. 2009 May-Jun;2(5-6):231-7. doi: 10.1242/dmm.001180.

    PubMed 19407331
  • Riccardi G, Rivellese AA. Dietary treatment of the metabolic syndrome--the optimal diet. Br J Nutr. 2000 Mar;83 Suppl 1:S143-8. doi: 10.1017/s0007114500001082.

    PubMed 10889805
  • Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.

    PubMed 17341711
  • Kossoff EH, Dorward JL. The modified Atkins diet. Epilepsia. 2008 Nov;49 Suppl 8:37-41. doi: 10.1111/j.1528-1167.2008.01831.x.

    PubMed 19049584
  • American Heart Association Nutrition Committee; Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006 Jul 4;114(1):82-96. doi: 10.1161/CIRCULATIONAHA.106.176158. Epub 2006 Jun 19.

    PubMed 16785338
  • Law M. Dietary fat and adult diseases and the implications for childhood nutrition: an epidemiologic approach. Am J Clin Nutr. 2000 Nov;72(5 Suppl):1291S-1296S. doi: 10.1093/ajcn/72.5.1291s.

    PubMed 11063471
  • Mansoor N, Vinknes KJ, Veierod MB, Retterstol K. Effects of low-carbohydrate diets v. low-fat diets on body weight and cardiovascular risk factors: a meta-analysis of randomised controlled trials. Br J Nutr. 2016 Feb 14;115(3):466-79. doi: 10.1017/S0007114515004699.

    PubMed 26768850
  • Forsythe CE, Phinney SD, Fernandez ML, Quann EE, Wood RJ, Bibus DM, Kraemer WJ, Feinman RD, Volek JS. Comparison of low fat and low carbohydrate diets on circulating fatty acid composition and markers of inflammation. Lipids. 2008 Jan;43(1):65-77. doi: 10.1007/s11745-007-3132-7. Epub 2007 Nov 29.

    PubMed 18046594
  • Ness-Abramof R, Apovian CM. Waist circumference measurement in clinical practice. Nutr Clin Pract. 2008 Aug-Sep;23(4):397-404. doi: 10.1177/0884533608321700.

    PubMed 18682591
  • Lagiou P, Sandin S, Lof M, Trichopoulos D, Adami HO, Weiderpass E. Low carbohydrate-high protein diet and incidence of cardiovascular diseases in Swedish women: prospective cohort study. BMJ. 2012 Jun 26;344:e4026. doi: 10.1136/bmj.e4026.

    PubMed 22735105
  • Brehm BJ, Seeley RJ, Daniels SR, D'Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab. 2003 Apr;88(4):1617-23. doi: 10.1210/jc.2002-021480.

    PubMed 12679447
  • Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77. doi: 10.7326/0003-4819-140-10-200405180-00006.

    PubMed 15148063
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Diet intervention in people with Metabolic Syndrome, run by Hawler Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of metabolic syndrome (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04681924, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.

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