The Influence of Daily Honey Consumption on IR in Obese Women With IR

Insulin Resistance Clinical Trial

Official title:

The Influence of Daily Honey Consumption on Insulin Resistance in Obese Women With Insulin Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427799
• Other study ID #: 2021/137
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: University of Jordan
• Contact: Shatha S Hammad, PhD
• Phone: +96265355000
• Email: sh.hammad[@]ju.edu.jo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to evaluate the effects of daily honey consumption on insulin resistance as a preventive measure against diabetes. in women with insulin resistance.

Description:

The prevalence rates of insulin resistance (IR) and its health consequences are increasing worldwide. The reputation of honey as a healthy alternative for sugar is largely accepted. Honey contains several bioactive constituents; however, its effect on IR measures and glycemic control is yet to be assessed. We aim to evaluate the effect of daily consumption of honey on IR and inflammatory status measures in obese women with insulin resistance in a free-living controlled intervention study. Sixty obese adult females with insulin resistance will be recruited from the community of the University of Jordan and from patients at the Endocrine unit at the University of Jordan Hospital. Participants will be randomly assigned into one of two treatment groups, honey group or jell-O group. Participants will consume a daily dose of 0.5 mg per kg of body weight of the prescribed treatment for 6 months. The effects of daily consumption of honey on IR, serum concentration of several inflammatory biomarkers, and body fatness will be evaluated. The results of this study would reveal the antidiabetic effect of the bioactive compounds in honey in insulin-resistant obese women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female
• 19-45 years
• Obese (BMI >= 30 kg/m^2)
• Premenopausal

Exclusion Criteria:

• Individual who use any drug or supplements known to affect lipid, glucose for at least the last three months.
• Individual who previous insulin treatment
• Smokers
• Individual who have diabetes, kidney, liver, or hormonal diseases
• Individual who have significant weight changes > 5% during the past 6 months
• Women who are postmenopausal

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• Honey
A mixed flora honey that will be obtained from local producers. and will be consumed by a daily dose of 0.5 g/kg body weight of honey by each participant and will be divided into two doses.
• Other carbohydrate alternatives such as jell-o
A daily dose of 0.5 g/kg body weight of Jell-O will be consumed by each participant and will be divided into two doses. Jell-O was selected as a source of sucrose with negligible phenolic capacity.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman	Amman, Jordan
Jordan	The University of Jordan	Amman	Amman, Jordan

Sponsors (2)

Lead Sponsor	Collaborator
University of Jordan	Abdul Hameed Shoman Foundation

Country where clinical trial is conducted

Jordan, 

References & Publications (30)

Abbey EL, Rankin JW. Effect of ingesting a honey-sweetened beverage on soccer performance and exercise-induced cytokine response. Int J Sport Nutr Exerc Metab. 2009 Dec;19(6):659-72. doi: 10.1123/ijsnem.19.6.659. — View Citation

Abdulrhman M, El Hefnawy M, Ali R, Abdel Hamid I, Abou El-Goud A, Refai D. Effects of honey, sucrose and glucose on blood glucose and C-peptide in patients with type 1 diabetes mellitus. Complement Ther Clin Pract. 2013 Feb;19(1):15-9. doi: 10.1016/j.ctcp — View Citation

Abu Rajab, A., Takruri, H., Mishal, A., & Alkurd, R. Glycemic and Insulinemic Response of Different Types of Jordanian Honey in Healthy and Type 2 Diabetic Volunteers. Pakistan Journal of Nutrition, 2017; 16(2), 61-68.

Agrawal OP, Pachauri A, Yadav H, Urmila J, Goswamy HM, Chapperwal A, Bisen PS, Prasad GB. Subjects with impaired glucose tolerance exhibit a high degree of tolerance to honey. J Med Food. 2007 Sep;10(3):473-8. doi: 10.1089/jmf.2006.070. — View Citation

Ajibola A., Physico-Chemical and Physiological Values of Honey and Its Importance as a Functional Food, International Journal of Food Sciences and Nutrition, 2015;2(6):1-9.

Al-Ismail K., Herzallah, S. M., &Rustom, A. S. Antioxidant activities of some edible wild mediterranean plants. Italian Journal of Food Science, 2007; 19(3).

Al-Waili NS. Natural honey lowers plasma glucose, C-reactive protein, homocysteine, and blood lipids in healthy, diabetic, and hyperlipidemic subjects: comparison with dextrose and sucrose. J Med Food. 2004 Spring;7(1):100-7. doi: 10.1089/1096620043229847 — View Citation

Alvarez-Suarez J.M. , Tulipani S., Romandini S., Bertoli E., and Battino M., Contribution of honey in nutrition and human health: a review, Mediterranean Journal of Nutrition and Metabolism, 2010;3(1):15-23.

Bermudez V, Salazar J, Martinez MS, Chavez-Castillo M, Olivar LC, Calvo MJ, Palmar J, Bautista J, Ramos E, Cabrera M, Pachano F, Rojas J. Prevalence and Associated Factors of Insulin Resistance in Adults from Maracaibo City, Venezuela. Adv Prev Med. 2016; — View Citation

de Rekeneire N, Peila R, Ding J, Colbert LH, Visser M, Shorr RI, Kritchevsky SB, Kuller LH, Strotmeyer ES, Schwartz AV, Vellas B, Harris TB. Diabetes, hyperglycemia, and inflammation in older individuals: the health, aging and body composition study. Diab — View Citation

Farakla I, Koui E, Arditi J, Papageorgiou I, Bartzeliotou A, Papadopoulos GE, Mantzou A, Papathanasiou C, Dracopoulou M, Papastamataki M, Moutsatsou P, Papassotiriou I, Chrousos GP, Charmandari E. Effect of honey on glucose and insulin concentrations in o — View Citation

Ferreres F., García-Viguera C., Tomás-Lorente F., and Tomás-Barberán F.A., Hesperetin: a marker of the floral origin of citrus honey, Journal of the Science of Food and Agriculture, vol. 61, no. 1, pp. 121-123, 1993.

Giugliano D, Ceriello A, Paolisso G. Oxidative stress and diabetic vascular complications. Diabetes Care. 1996 Mar;19(3):257-67. doi: 10.2337/diacare.19.3.257. — View Citation

Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874. — View Citation

Kumar S., Safi S. Z., Qvist R., and Ismail I. S., Effect of agonists of adenosine receptors on inflammatory markers in human Muller cells, Current Science, 2014;106(4):582-586.

Li N, Brun T, Cnop M, Cunha DA, Eizirik DL, Maechler P. Transient oxidative stress damages mitochondrial machinery inducing persistent beta-cell dysfunction. J Biol Chem. 2009 Aug 28;284(35):23602-12. doi: 10.1074/jbc.M109.024323. Epub 2009 Jun 22. — View Citation

Molan PC. A brief review of honey as a clinical dressing. Prim Intention. 1998;6:148-158.

Moniruzzaman M, Khalil MI, Sulaiman SA, Gan SH. Advances in the analytical methods for determining the antioxidant properties of honey: a review. Afr J Tradit Complement Altern Med. 2011 Oct 2;9(1):36-42. doi: 10.4314/ajtcam.v9i1.5. eCollection 2012. — View Citation

Nemoseck TM, Carmody EG, Furchner-Evanson A, Gleason M, Li A, Potter H, Rezende LM, Lane KJ, Kern M. Honey promotes lower weight gain, adiposity, and triglycerides than sucrose in rats. Nutr Res. 2011 Jan;31(1):55-60. doi: 10.1016/j.nutres.2010.11.002. — View Citation

Oliveira LS, Santos DA, Barbosa-da-Silva S, Mandarim-de-Lacerda CA, Aguila MB. The inflammatory profile and liver damage of a sucrose-rich diet in mice. J Nutr Biochem. 2014 Feb;25(2):193-200. doi: 10.1016/j.jnutbio.2013.10.006. Epub 2013 Nov 15. — View Citation

Pasupuleti VR, Sammugam L, Ramesh N, Gan SH. Honey, Propolis, and Royal Jelly: A Comprehensive Review of Their Biological Actions and Health Benefits. Oxid Med Cell Longev. 2017;2017:1259510. doi: 10.1155/2017/1259510. Epub 2017 Jul 26. — View Citation

Qi Q, Bray GA, Smith SR, Hu FB, Sacks FM, Qi L. Insulin receptor substrate 1 gene variation modifies insulin resistance response to weight-loss diets in a 2-year randomized trial: the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) tria — View Citation

Rao P.V., Krishnan K.T., Salleh N., and Gan S.H., Biological and therapeutic effects of honey produced by honey bees and stingless bees: a comparative review, RevistaBrasileira de Farmacognosia. 2016;26(5):657-664.

Riccardi G, Giacco R, Rivellese AA. Dietary fat, insulin sensitivity and the metabolic syndrome. Clin Nutr. 2004 Aug;23(4):447-56. doi: 10.1016/j.clnu.2004.02.006. — View Citation

Roncal-Jimenez CA, Lanaspa MA, Rivard CJ, Nakagawa T, Sanchez-Lozada LG, Jalal D, Andres-Hernando A, Tanabe K, Madero M, Li N, Cicerchi C, Mc Fann K, Sautin YY, Johnson RJ. Sucrose induces fatty liver and pancreatic inflammation in male breeder rats indep — View Citation

Safi SZ, Qvist R, Yan GO, Ismail IS. Differential expression and role of hyperglycemia induced oxidative stress in epigenetic regulation of beta1, beta2 and beta3-adrenergic receptors in retinal endothelial cells. BMC Med Genomics. 2014 May 30;7:29. doi: — View Citation

Samuel VT, Shulman GI. Mechanisms for insulin resistance: common threads and missing links. Cell. 2012 Mar 2;148(5):852-71. doi: 10.1016/j.cell.2012.02.017. — View Citation

Sattar N., Perry C.G., and Petrie J. R. Type 2 diabetes as an inflammatory disorder, The British Journal of Diabetes and Vascular Disease, 2003;3(1):36-41.

Tartibian B, Maleki BH. The effects of honey supplementation on seminal plasma cytokines, oxidative stress biomarkers, and antioxidants during 8 weeks of intensive cycling training. J Androl. 2012 May-Jun;33(3):449-61. doi: 10.2164/jandrol.110.012815. Epu — View Citation

Yaghoobi N, Al-Waili N, Ghayour-Mobarhan M, Parizadeh SM, Abasalti Z, Yaghoobi Z, Yaghoobi F, Esmaeili H, Kazemi-Bajestani SM, Aghasizadeh R, Saloom KY, Ferns GA. Natural honey and cardiovascular risk factors; effects on blood glucose, cholesterol, triacy — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary intake (3-day food record)	Participants will provide a 3-day food record. Dietary data will be analyzed for energy, macro- and micro-nutrients composition using the food processor SQL version 10.3.0 program (ESHA Research, Salem, Oregon).	At the beginning of the study
Primary	Dietary intake	Participants will provide a 3-day food record. Dietary data will be analyzed for energy, macro- and micro-nutrients composition using the food processor SQL version 10.3.0 program (ESHA Research, Salem, Oregon).	Change from Baseline at 4 months
Primary	Dietary intake (A daily treatment consumption)	A daily treatment consumption checklist will be filled by each participant using the mobile App.	Every day of the treatment period (4 months)
Primary	Anthropometric measurements (Height)	Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.	On the first day
Primary	Anthropometric measurements (Weight)	Weight will be measured using a calibrated digital scale to the nearest 0.1 kg. All participants will be measured in light clothing and without any heavy articles or footwear.	Change from Baseline at 4 months
Primary	Anthropometric measurements (Waist circumference)	The average waist circumference will be calculated from 2 consecutive measurements at the midway between the lowest rib and iliac crest.	Change from Baseline at 4 months
Primary	Anthropometric measurements (A body composition assessment)	A body composition assessment will be performed using InBody120 analyzer (InBody, CO.). Participants will be asked to remove any metal items and heavy clothes before scanning, and will be scanned barefoot and wearing light clothes. Participant positioning will be conducted in accordance with the operator's manual.A trained operator will assess body composition according to the manufacturer's instructions.	Change from Baseline at 4 months
Primary	Biochemical measurements (OGTT)	OGTT (75 g of glucose) will be executed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws. During OGTT venous blood samples will be obtained at 0, 30, 60, 90 and 120 min for the determination of glucose and insulin.	Change from Baseline at 4 months
Primary	Biochemical measurements (OHTT)	OHTT (75 g of honey) will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws. During OHTT venous blood samples will be obtained at 0, 30, 60, 90 and 120 min for the determination of glucose and insulin.	Change from Baseline at 4 months
Primary	Biochemical measurements (Glucose level)	Glucose level test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (Insulin level)	Insulin level test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (HbA1C)	HbA1C test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (Adiponectin)	Adiponectin test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (C-reactive protein)	C-reactive protein test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (Triglyceride)	Triglyceride test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (Total cholesterol)	Total cholesterol test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months
Primary	Biochemical measurements (High density lipoprotein- cholesterol (HDL-C))	High density lipoprotein- cholesterol (HDL-C) test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.	Change from Baseline at 4 months

External Links

•   Prevalence and Associated Factors of Insulin Resistance in Adults from Maracaibo City, Venezuela