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Obesity-related Health Benefits of Apples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523403
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Ontario Ministry of Agriculture, Food and Rural Affairs
Ontario Apple Growers
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Lindsay Robinson, University of Guelph

Brief Summary:
Obesity is characterized by an underlying inflammatory state in which various inflammatory signaling molecules, termed cytokines, affect metabolic processes central to type 2 diabetes and cardiovascular disease; leading causes of disability and death in Ontario. Such obesity-associated inflammation is partly due to the movement of endotoxin (i.e. lipopolysaccharide (LPS), a cell wall component of Gram-negative bacteria) from the gut microbiota to the blood, resulting in elevated blood levels of LPS (a condition termed metabolic endotoxemia) that stimulates inflammation. Digestion of a high-fat meal increases blood LPS and is subsequently associated with inflammation and metabolic impairments. However, in this context, little is known about how the consumption of bioactive-rich foods, such as whole apples, can improve impaired inflammatory and metabolic responses in overweight and obese individuals. Apples are a key commodity to study given that they are Ontario's predominant fruit crop with the apple industry valued at approximately $400 million, they require little food preparation, and they are common in the diet year-round. There are some, but limited, reports of potential apple-induced health benefits related to reductions in inflammation and improved metabolic responses in lean/healthy individuals, but work in overweight and obese individuals is especially lacking. Thus, to address the gap in our understanding of how daily apple intake may improve the health consequences of obesity, we will conduct a randomized clinical trial in which overweight and obese adults will consume three Ontario-grown Gala apples (approximately 300 g) as part of their typical diet in one sitting (i.e. acute consumption) and/or daily for six weeks (i.e. chronic consumption). The Acute Apple Consumption phase of the study will follow a randomized crossover design in which participants' rate of gastric emptying, efficacy of dietary lipid digestion and absorption, and production of inflammatory cytokines and biomarkers of metabolism will be assessed before and after consuming a high-fat meal (designed to provide 1 g fat/kg body weight) with or without three apples in one sitting. The Chronic Apple Consumption phase of the study will follow a randomized, controlled, parallel-arm design in which participants' (fasting) production of inflammatory cytokines and biomarkers of metabolism, as well as their gut microbiota profile, will be assessed before and after consuming three apples (or no apples) daily for six weeks. We hypothesize that the consumption of three whole apples in one sitting and daily for six weeks will improve these parameters in overweight and obese individuals at risk of developing chronic metabolic diseases.

Condition or disease Intervention/treatment Phase
Obesity, Abdominal Hyperlipidemias Inflammation Dysbiosis Other: Apples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All 60 participants will participate in the Chronic phase of the study, which will follow a randomized, controlled, parallel-arm design to investigate the effects of consuming 3 apples per day for 6 weeks. 30 of those 60 participants will also participate in the Acute phase of the study, which will follow a randomized, crossover design to investigate the effects of eating 3 apples in addition to a high-fat meal in one sitting.
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Apple Study: Investigating the Effects of Whole Apple Consumption on Risk Factors for Chronic Metabolic Diseases in Overweight and Obese Adults
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acute phase - intervention
Participants will be asked to consume 3 whole apples and a high-fat meal (a mixture of commercially available whipping cream and milk, providing 1 g of fat per kg of body weight) within 30 minutes.
Other: Apples
3 whole Ontario-grown Gala apples

No Intervention: Acute phase - control
Participants will be asked to consume a high-fat meal (a mixture of commercially available whipping cream and milk, providing 1 g of fat per kg of body weight) within 30 minutes.
Experimental: Chronic phase - intervention group
Participants will be asked to consume 3 whole apples per day for 6 weeks.
Other: Apples
3 whole Ontario-grown Gala apples

No Intervention: Chronic phase - control group
Participants will be asked to consume no apples per day for 6 weeks.



Primary Outcome Measures :
  1. Plasma triglyceride levels [ Time Frame: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially ]
  2. Plasma inflammatory cytokine levels [ Time Frame: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially ]
    E.g. adiponectin, leptin, IL-1B, IL-6, IL-10, TNF-a, MCP-1, MIP-1a, etc.

  3. Gut microbiota profile [ Time Frame: Immediately before and after the 6-week Chronic phase of the study ]
    16S rRNA gene sequencing to identify different microbes within fecal samples, representative of the gut microenvironment


Secondary Outcome Measures :
  1. Fatty acid composition of chylomicron-rich fraction of blood [ Time Frame: For the Acute phase of the study only: fasting and 120, 240, and 360 minutes post-prandially ]
  2. Plasma ApoB48 levels [ Time Frame: For the Acute phase of the study only: fasting and 120, 240, and 360 minutes post-prandially ]
  3. Rate of gastric emptying [ Time Frame: For the Acute phase of the study only: fasting and 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially ]
    Rate that acetaminophen (contained in the high-fat meal) appears in the blood post-prandially

  4. Levels of inflammatory cytokines secreted from peripheral blood mononuclear cells isolated from whole blood samples and stimulated with or without lipopolysaccharide [ Time Frame: Fasting, and for the Acute phase of the study only: 240 post-prandially ]
    E.g. adiponectin, leptin, IL-1B, IL-6, IL-10, TNF-a, MCP-1, MIP-1a, etc.

  5. Plasma lipopolysaccharide binding protein [ Time Frame: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially ]
  6. Plasma glucose levels [ Time Frame: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially ]
  7. Plasma insulin levels [ Time Frame: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 75 years old
  • BMI ≥ 25 kg/m2 and/or waist circumference ≥ 40" for males or ≥ 30" for females
  • Current/prior use of acetaminophen without complications

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Fasting blood glucose ≥ 7.0 mmol/L
  • Chronic diseases, including by not limited to: type 2 diabetes, cardiovascular disease, liver disease, etc.
  • Gastrointestinal conditions or illnesses, including but not limited to: lactose intolerance, Celiac disease, Crohn's disease, Ulcerative Colitis, Irritable Bowel Disorder
  • Inflammatory conditions or active infection
  • Serious major medical condition requiring hospitalization within the last year
  • Taking any prescription medications (including hormonal contraceptives) or over the counter medications prescribed by a medical professional
  • Taking any natural health products or dietary supplements, other than a multivitamin low in phenolic acids
  • Taking any medication or natural health product contraindicated with acetaminophen
  • Allergy to acetaminophen
  • Use of immunomodulating agents
  • Antibiotic use within last 3 months
  • Alcohol consumption of ≥ 4 drinks/sitting or ≥ 14 drinks/week
  • Use of tobacco products or recreational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523403


Locations
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Canada, Ontario
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Ontario Ministry of Agriculture, Food and Rural Affairs
Ontario Apple Growers
Agriculture and Agri-Food Canada
Investigators
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Study Director: Danyelle M Liddle, MSc University of Guelph
Study Director: Xinjie Lin, MSc University of Guelph
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Responsible Party: Lindsay Robinson, Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT03523403    
Other Study ID Numbers: UGuelph Apple Study
UofG2014-2028 ( Other Grant/Funding Number: Ontario Ministry of Agriculture, Food and Rural Affairs )
UofG2014-2028 ( Other Grant/Funding Number: Ontario Apple Growers )
REB#16JA013 ( Other Identifier: Research Ethics Board, University of Guelph )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lindsay Robinson, University of Guelph:
Obesity
Diet
Apples
Polyphenols
Soluble fibre
Blood lipids
Lipid digestion
Inflammation
Cytokines
Microbiota
Dysbiosis
Type 2 diabetes risk
Cardiovascular disease risk
Additional relevant MeSH terms:
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Obesity
Hyperlipidemias
Obesity, Abdominal
Inflammation
Dysbiosis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases