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

NCT05427799 | Completed

• 1 other identifier: 2021/137
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insulin Resistance

Keywords

Insulin resistance

Outcome Measures

Primary Outcomes (16)

• 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

• 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)

• Anthropometric measurements (Height)

  Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.

  On the first day

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• Dietary intake (3-day food record)

  At the beginning of the study

Study Arms (2)

Honey

EXPERIMENTAL

Treatment with honey will extend for four months and the actual treatment phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from honey consumption. During the six months intervention, a daily dose of 0.5 g/kg body weight of honey will be consumed by each participant. Participants will be provided with Mixed flora honey that will be obtained from local producers. The daily dose of treatments will be divided into two doses to simulate a natural pattern of consumption. All participants will be required to limit the consumption of caffeinated beverages to two beverages a day during the study periods. A nutritionist will calculate the energy requirement and provide dietary instructions and a nutritionally adequate, hypocaloric, balanced sample diet plan with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein will be individualized for each participant monthly.

Dietary Supplement: Honey

Other carbohydrate alternatives

PLACEBO COMPARATOR

Treatment with simple sugar alternatives (other carbohydrates, such as jell-o) will extend for four months and the actual treatment phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from honey consumption, and during the study periods. 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 to simulate a natural pattern of consumption. Jell-O was selected as a source of sucrose with negligible phenolic capacity, which will serve as a control. All participants will be required to limit the consumption of caffeinated beverages to two beverages a day during the study periods. A nutritionist will calculate the energy requirement and provide dietary instructions and a nutritionally adequate, hypocaloric, balanced sample diet plan with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein will be individualized for each participant monthly.

Dietary Supplement: Other carbohydrate alternatives such as jell-o

Interventions

Honey DIETARY_SUPPLEMENT

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.

Honey

Other carbohydrate alternatives such as jell-o DIETARY_SUPPLEMENT

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.

Other carbohydrate alternatives

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: Obese women with insulin resistance
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abdul Hameed Shoman Foundation: collaborator
• University of Jordan: lead

Study Sites (2)

Jordan University Hospital

Amman, Amman, Jordan, 11942, Jordan

Location

The University of Jordan

Amman, Amman, Jordan, 11942, Jordan

Location

Related Publications (30)

• 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.

  PMID: 17887941 BACKGROUND

• 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.

  PMID: 20175433 RESULT

• 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.2012.08.002. Epub 2012 Oct 9.

  PMID: 23337559 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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).

  RESULT

• 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.

  RESULT

• 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;2016:9405105. doi: 10.1155/2016/9405105. Epub 2016 Aug 4.

  PMID: 27579182 RESULT

• 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 obese girls. Eur J Clin Invest. 2019 Feb;49(2):e13042. doi: 10.1111/eci.13042. Epub 2018 Nov 16.

  PMID: 30368796 RESULT

• 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.

  RESULT

• 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.

  PMID: 8742574 RESULT

• 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.

  PMID: 25593845 RESULT

• 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.

  RESULT

• 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.

  PMID: 19546218 RESULT

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

  RESULT

• 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.

  PMID: 23983317 RESULT

• 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. Diabetes Care. 2006 Aug;29(8):1902-8. doi: 10.2337/dc05-2327.

  PMID: 16873800 RESULT

• 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.

  PMID: 21310307 RESULT

• 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.

  PMID: 24445044 RESULT

• 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.

  PMID: 28814983 RESULT

• 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) trial. Circulation. 2011 Aug 2;124(5):563-71. doi: 10.1161/CIRCULATIONAHA.111.025767. Epub 2011 Jul 11.

  PMID: 21747052 RESULT

• 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.

  RESULT

• 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.

  PMID: 15297079 RESULT

• 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 independent of excess energy intake. Metabolism. 2011 Sep;60(9):1259-70. doi: 10.1016/j.metabol.2011.01.008. Epub 2011 Apr 12.

  PMID: 21489572 RESULT

• 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: 10.1186/1755-8794-7-29.

  PMID: 24885710 RESULT

• 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.

  PMID: 22385956 RESULT

• 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.

  RESULT

• 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. Epub 2011 Jun 2.

  PMID: 21636735 RESULT

• 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: 10.1089/109662004322984789.

  PMID: 15117561 RESULT

• 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, triacylglycerole, CRP, and body weight compared with sucrose. ScientificWorldJournal. 2008 Apr 20;8:463-9. doi: 10.1100/tsw.2008.64.

  PMID: 18454257 RESULT

Related Links

• Type 2 diabetes as an inflammatory disorder
• Prevalence and Associated Factors of Insulin Resistance in Adults from Maracaibo City, Venezuela

MeSH Terms

Conditions

Insulin Resistance

Interventions

Honey; Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Shatha S Hammad, PhD

  The University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: a parallel, single-blind, randomized trial

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 22, 2022
• Study Start: March 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)