Sub-Study of the PREVIEW Study Australia

NCT02030249 | Unknown

• 2 other identifiers: 2013/535 - SUB-STUDYKBBE-CALL- 6-Nr. 312057
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to investigate possible enduring effects of a standard 2-month weight loss program on appetite regulation, bone homeostasis and muscle strength in younger and older adults, as well as the impact of differences in dietary composition during weight maintenance.

Conditions

Pre-diabetes; Obesity

Keywords

Pre-diabetes; Obesity; Low calorie diet; Diet - reducing; Appetite; Visual analogue scale; Ghrelin; Peptide YY; Bone mass; Bone turnover; Muscle strength

Outcome Measures

Primary Outcomes (2)

• Fasting appetite

  Previous research has shown that a weight reducing diet increases appetite in the fasting state. There is some suggestion that this diet-induced increase in appetite is sustained even after following a weight maintenance diet for 12 months. We will assess fasting appetite using visual analogue scales after commencement of the standardized weight loss diet. This primary outcome will demonstrate whether the weight-loss-induced increase in fasting appetite that is anticipated at completion of the diet will be normalized by the 12 month time point, and whether the type of weight maintenance diet (High Protein / Low Glycaemic Index versus Moderate Protein / High Glycaemic Index) influences this.

  12 months

• Bone mass

  We will assess bone mineral density and bone mineral content in the lumbar spine and hip (or wrist for people in whom arthritis interferes with the reading) via dual energy X-ray absorptiometry (DXA) at 2 months after commencement of the standardized weight loss diet. This primary outcome will help determine whether there is a difference between younger and older participants with respect to changes in bone mass with weight reduction, and whether the type of weight maintenance diet influences this.

  2 months

Secondary Outcomes (34)

• Fasting appetite

  0 months

• Fasting appetite

  2 months

• Fasting appetite

  6 months

• Fasting appetite

  24 months

• Fasting appetite

  36 months

Other Outcomes (6)

• Urinary N-terminal telopeptide

  0 months

• Urinary N-terminal telopeptide

  2 months

• Urinary N-terminal telopeptide

  6 months

Study Arms (2)

High Protein / Low Glycaemic Index

EXPERIMENTAL

A 10-month weight maintenance diet, administered from the 2-month to the 12-month time point, where protein intake is 25% of energy intake, carbohydrate intake is 45% of energy intake, dietary glycaemic index is \< 55. Please see parent study for further Arm details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview\&rank=1

Behavioral: Low calorie diet administered from 0 to 2 months; Behavioral: High Protein / Low Glycaemic Index

Moderate Protein / High Glycaemic Index

ACTIVE COMPARATOR

A 10-month weight maintenance diet, administered from the 2-month to the 12-month time point, where protein intake is 15% of energy intake, carbohydrate intake is 55% of energy intake, dietary glycaemic index is \> 65. Please see parent study for further Arm details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview\&rank=1

Behavioral: Low calorie diet administered from 0 to 2 months; Behavioral: Moderate Protein / High Glycaemic Index

Interventions

Low calorie diet administered from 0 to 2 months BEHAVIORAL

The 2-month low calorie diet is administered from the 0 months to the 2 months time point. It is designed to elicit a weight loss of 8% of initial body weight. Please see parent study for further intervention details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview\&rank=1

Also known as: 2-month low calorie diet, 2-month standardized low calorie diet, 2-month Cambridge Diet, 2-month low energy diet

High Protein / Low Glycaemic Index; Moderate Protein / High Glycaemic Index

High Protein / Low Glycaemic Index BEHAVIORAL

Please see description of the Arm by the same name.

High Protein / Low Glycaemic Index

Moderate Protein / High Glycaemic Index BEHAVIORAL

Please see description of the Arm by the same name.

Moderate Protein / High Glycaemic Index

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25 - 45 years and 55 - 70 years
• Overweight or obesity status BMI\>25 kg/m2
• Informed consent required
• Ethnic group - No restrictions
• Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
• Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol
• Other - Able to participate at CID's during normal working hours.

You may not qualify if:

• Based on interview and/or questionnaire, individuals with the following problems will be excluded:
• Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder).
• Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
• Personal/Other: Engagement in competitive sports; Self-reported weight change of \>5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking \> 21 alcoholic units/week (men), or \> 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol.
• Laboratory screening: If all of the above criteria are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation.
• Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age.

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (3)

The University of Sydney

Camperdown, New South Wales, 2006, Australia

Location

Garvan Institute of Medical Research

Darlinghurst, Sydney, New South Wales, 2010, Australia

Location

Prince of Wales Hospital

Randwick, Sydney, New South Wales, 2031, Australia

Location

Related Publications (9)

• Sainsbury A, Zhang L. Role of the arcuate nucleus of the hypothalamus in regulation of body weight during energy deficit. Mol Cell Endocrinol. 2010 Mar 25;316(2):109-19. doi: 10.1016/j.mce.2009.09.025. Epub 2009 Oct 12.

  PMID: 19822185 BACKGROUND

• Sainsbury A, Zhang L. Role of the hypothalamus in the neuroendocrine regulation of body weight and composition during energy deficit. Obes Rev. 2012 Mar;13(3):234-57. doi: 10.1111/j.1467-789X.2011.00948.x. Epub 2011 Nov 10.

  PMID: 22070225 BACKGROUND

• Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.

  PMID: 22029981 BACKGROUND

• Westerterp-Plantenga MS, Lejeune MP, Nijs I, van Ooijen M, Kovacs EM. High protein intake sustains weight maintenance after body weight loss in humans. Int J Obes Relat Metab Disord. 2004 Jan;28(1):57-64. doi: 10.1038/sj.ijo.0802461.

  PMID: 14710168 BACKGROUND

• Brand-Miller JC, Holt SH, Pawlak DB, McMillan J. Glycemic index and obesity. Am J Clin Nutr. 2002 Jul;76(1):281S-5S. doi: 10.1093/ajcn/76/1.281S.

  PMID: 12081852 BACKGROUND

• Soenen S, Martens EA, Hochstenbach-Waelen A, Lemmens SG, Westerterp-Plantenga MS. Normal protein intake is required for body weight loss and weight maintenance, and elevated protein intake for additional preservation of resting energy expenditure and fat free mass. J Nutr. 2013 May;143(5):591-6. doi: 10.3945/jn.112.167593. Epub 2013 Feb 27.

  PMID: 23446962 BACKGROUND

• Chapman IM. Obesity in old age. Front Horm Res. 2008;36:97-106. doi: 10.1159/000115358.

  PMID: 18230897 BACKGROUND

• Westerterp-Plantenga MS, Lemmens SG, Westerterp KR. Dietary protein - its role in satiety, energetics, weight loss and health. Br J Nutr. 2012 Aug;108 Suppl 2:S105-12. doi: 10.1017/S0007114512002589.

  PMID: 23107521 BACKGROUND

• Buso MEC, Seimon RV, McClintock S, Muirhead R, Atkinson FS, Brodie S, Dodds J, Zibellini J, Das A, Wild-Taylor AL, Burk J, Fogelholm M, Raben A, Brand-Miller JC, Sainsbury A. Can a Higher Protein/Low Glycemic Index vs. a Conventional Diet Attenuate Changes in Appetite and Gut Hormones Following Weight Loss? A 3-Year PREVIEW Sub-study. Front Nutr. 2021 Mar 22;8:640538. doi: 10.3389/fnut.2021.640538. eCollection 2021.

  PMID: 33829034 DERIVED

Related Links

• This is a sub-study of a larger study registered on ClinicalTrials.gov - Effect of Diet and Physical Activity on Incidence of Type 2 Diabetes (PREVIEW): NCT01777893

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Amanda Salis (nee Sainsbury), PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 8, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 31, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

AU (3)