Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors

Physical Activity Clinical Trial

Official title:

Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors in South Asian and White European Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698786
• Other study ID #: KingstonUSport2
• Status: Completed
• Start date: May 24, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: Kingston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to examine the effect of a single bout of moderate exercise, standardized breakfast and buffet meal on appetite-related hormones, type two diabetes and cardiovascular risk factors with a comparison between healthy South Asian and white European men. It is of interest to see if any factor differences occur in appetite-regulating hormones and cardiovascular disease risk factors whilst exercising. If so strategies may be used to alter regulation in diet and exercise to reduce risk cardiovascular disease as this is the number one cause of death globally.

Description:

Cardiovascular diseases are recognised as the number one cause of death globally. Furthermore, diabetes is a major risk factor for cardiovascular disorders with abundant evidence showing that patients with type 2 diabetes (T2D) are at higher risk of cardiovascular disease (CVD) than those with a normal glycaemia.

In contrast to the declining numbers in the Western world, the prevalence of CVD and T2D is growing in low - and middle - income countries accompanied by a rapid increase of mortality and morbidity. Of interest, a rise in CVD prevalence has been particularly observed in people of South Asian origin including India, Bangladesh, Pakistan, Sri Lanka or Nepal with a projection showing that in this population deaths attributed to CVD will rise globally to nearly 36 % in 2030 compared to 29 % in 2005. South Asians collectively form 20% of the global population while in the UK they are the largest ethnic minority group representing over 5% of the total UK population .

Although the majority of research has been conducted mainly on White individuals, recent studies have revealed that traditional CVD risk factors such as hypertension, dyslipidaemia, insulin resistance and diabetes are higher in South Asians than other ethnicities. The factors underlying the high CVD risk in this population remain largely unexplained even though genetic predisposition and physical inactivity could play a key role. In contrast to European counterparts, sedentary lifestyles or physical inactivity have been identified as an important coronary heart disease (CHD) risk factor in South Asians. A systematic review from the United Kingdom (U.K.) showed that South Asians are participating in up to 50-75% less physical activity compared to their European counterparts.

In addition to the traditional risk factors there are emerging biomarkers which could represent meaningful predictors of metabolic disorders and related complications. Specifically, appetite hormones secreted mainly by the gastrointestinal tract, such as Acylated Ghrelin or Peptide YY (PYY) have shown potential effects on glucose homeostasis and cardiovascular system. Current experimental studies suggest beneficial cardiovascular, anti-inflammatory and anti-apoptotic effects of ghrelin in the cardiovascular system.

Although evidence suggests that ghrelin may be a potential metabolic risk factor and is important in appetite regulation, no studies to the researcher's knowledge have examined changes of this peptide in South Asians despite the fact that CVD and T2D burden in the South Asian population is growing. Likewise, although studies have investigated the effects of exercise on ghrelin and other appetite hormones, no study has taken in consideration the effects of exercise on appetite gut hormones in South Asian populations.

Therefore, this research project aims to examine specific appetite hormones in response to a single bout of exercise, standardised meal and ad libitum buffet meal, with a comparison between South Asians and White Europeans identifying potential relationships with genetic and other metabolic risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2019
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Non-smoker

• Non-dieting

• Physically well to participant in maximal exercise

• Male

• Not taking any anticoagulant or anti-inflammatory medication

• Between the ages 18-50

• White European or South Asian

Exclusion Criteria:

• Those that are taking any anticoagulant or anti-inflammatory medication

• Those with a known medical condition such as diabetes, cardiovascular disease.

Related Conditions & MeSH terms

• Glucose Intolerance
• Physical Activity
• Pre-diabetes
• Prediabetic State
• Risk Factor, Cardiovascular

Intervention

Behavioral:
• Exercise
Participants will be required to complete two, 8-hours trials (exercise & control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions.

Locations

Country	Name	City	State
United Kingdom	Applied & Human Sciences Human Performance Lab	Kingston Upon Thames	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Kingston University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

Bailey DP, Smith LR, Chrismas BC, Taylor L, Stensel DJ, Deighton K, Douglas JA, Kerr CJ. Appetite and gut hormone responses to moderate-intensity continuous exercise versus high-intensity interval exercise, in normoxic and hypoxic conditions. Appetite. 2015 Jun;89:237-45. doi: 10.1016/j.appet.2015.02.019. Epub 2015 Feb 17. — View Citation

Deighton K, Barry R, Connon CE, Stensel DJ. Appetite, gut hormone and energy intake responses to low volume sprint interval and traditional endurance exercise. Eur J Appl Physiol. 2013 May;113(5):1147-56. doi: 10.1007/s00421-012-2535-1. Epub 2012 Oct 31. — View Citation

Gholap N, Davies M, Patel K, Sattar N, Khunti K. Type 2 diabetes and cardiovascular disease in South Asians. Prim Care Diabetes. 2011 Apr;5(1):45-56. doi: 10.1016/j.pcd.2010.08.002. Epub 2010 Sep 25. Review. — View Citation

Gijsberts CM, den Ruijter HM, Asselbergs FW, Chan MY, de Kleijn DP, Hoefer IE. Biomarkers of Coronary Artery Disease Differ Between Asians and Caucasians in the General Population. Glob Heart. 2015 Dec;10(4):301-311.e11. doi: 10.1016/j.gheart.2014.11.004. Epub 2015 Mar 7. Review. — View Citation

Gujral UP, Pradeepa R, Weber MB, Narayan KM, Mohan V. Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations. Ann N Y Acad Sci. 2013 Apr;1281:51-63. doi: 10.1111/j.1749-6632.2012.06838.x. Epub 2013 Jan 14. Review. — View Citation

Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953. Review. — View Citation

King JA, Garnham JO, Jackson AP, Kelly BM, Xenophontos S, Nimmo MA. Appetite-regulatory hormone responses on the day following a prolonged bout of moderate-intensity exercise. Physiol Behav. 2015 Mar 15;141:23-31. doi: 10.1016/j.physbeh.2014.12.050. Epub 2015 Jan 3. — View Citation

Wulan SN, Westerterp KR, Plasqui G. Metabolic profile before and after short-term overfeeding with a high-fat diet: a comparison between South Asian and White men. Br J Nutr. 2014 May 28;111(10):1853-61. doi: 10.1017/S0007114514000014. Epub 2014 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Acylated ghrelin concentration	Plasma acylated ghrelin will be examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Bertin Bioreagent, Montigny le Bretonneux, France) will be used to measure plasma acylated ghrelin concentration. The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Plasma TAG concentration	Plasma Insulin will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Mercodia, Uppsala, Sweden) will be used to measure plasma Insulin concentration. The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Plasma triacylglycerol (TAG) concentration	Plasma TAG concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Plasma high-density lipoprotein (HDL) cholesterol concentration	Plasma HDL concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Cardiorespiratory fitness	Cardiorespiratory fitness will be determined during the preliminary test (please refer to study design for details) using an incremental exercise test to volitional exhaustion on an electromagnetically braked cycle ergometer (Lode Excalibur Sport, Groningen, Netherlands). Participants will cycle at a self-selected pedal rate between 70 to 90 revolutions per minute for 3 min at 80 watts (warm up), followed by increments of 30 watts every 3 minutes until volitional fatigue. The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Plasma Glucose concentration for impaired glucose tolerance (IGT)	Plasma glucose concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Plasma Peptide YY concentration	Plasma PYY will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Millipore, Billerica, USA) will be used to measure plasma PYY concentration. The sample will be collected from whole blood using venepuncture.	2 days
Secondary	Plasma Leptin concentration	Plasma leptin will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Millipore, Billerica, USA) will be used to measure plasma leptin concentration. The sample will be collected from whole blood using venepuncture.	2 days