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临床试验/NCT02347007
NCT02347007已完成不适用

Impact of Almond Supplementation, Relative to a Low-fat, High Carbohydrate Control, on Body Composition in Overweight and Obese Black and Hispanic Adults

Columbia University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change in body Composition

研究概览

简要总结

The purpose of this study is to determine whether introducing almonds into the diet of overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and lowers cardiovascular disease profile.

详细描述

The study is a randomized, controlled study aimed at testing whether almonds, consumed within a free-living, self-selected diet, improve body composition and liver fat, relative to a low-fat/high-carbohydrate cereal bar (LF-HC) in overweight and obese Blacks and Hispanics. A secondary aim is to determine whether almond consumption will lead to an overall lower CVD risk profile.

Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily (2-3 oz) or a high-carbohydrate cereal bar (2 g of fat or less per 100 kcal) providing an equivalent amount of calories. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their food supplement as a mid-afternoon snack and the rest at a meal of their choice.

At the baseline visit, participants will be given a 2-week supply of their allocated food supplement and will obtain additional supplies at bi-weekly visits for the first 8 weeks. After the week 8 visit, participants will be given monthly rations of their food supplement, either almonds or LF-HC cereal bar, and will be asked to come to research center every 4 weeks to obtain their next supply. At those visits, body weight and blood pressure will be measured and participants will turn in weekly dietary diaries, reporting their supplement intake. Participants will also receive one random phone call every 4 weeks to provide a 24-h recall. This recall will be used as an index of dietary quality but also as a compliance check with dietary supplements. In addition, 3-day food records will be collected prior to the start of the study and during the final week to assess any dietary changes due to the intervention. A food frequency questionnaire will also be administered at screening and endpoint of the study. This food-frequency questionnaire will target nut consumption.

At the end of the study, intention to continue eating almonds or a low-fat diet will be assessed using questions adapted from de Bruijn et al. Participants in the almond group will be asked the following questions: (1) "I intend to include almonds in my diet" (+2 = yes, definitely; -2 = no, definitely); (2) "How certain are you that you will include almonds in your diet?" (+2 = very certain; -2 = very uncertain); (3) "Including almonds in my diet is" (instrumental attitude: +3 = healthy; -3 = unhealthy; affective attitude: +3 = pleasant; -3 = unpleasant); (4) "I find including almonds in my diet" (perceived behavioral control: +3 = easy; -3 = difficult). Corresponding questions for the control group will replace "include almonds" with "reduce the amount of fat". Participants will be called 4 weeks later to obtain information on their actual almond and fat intakes by questionnaire and 24-h recall.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Black and/or Hispanic
  • Body Mass Index (BMI) 25-35 kg/m^2
  • Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
  • Body weight less than 300 pounds
  • Adherence to an acceptable form of contraception (for women)
  • If taking medicine, dose must have been stable before study; must remain on same medication and dose throughout study.

排除标准

  • Uncontrolled hypertension (high blood pressure)
  • Cardiovascular disease
  • Weight loss attempted in past 3 months
  • Eating disorder
  • Stroke, seizure disorder, or significant neurological disease
  • Unstable of uncontrolled medical illness including active malignancies within past 5 years
  • Untreated or unstable hypothyroidism
  • Hyperthyroidism
  • Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
  • Alcohol or substance abuse in the past 6 months
  • Pregnant, planning pregnancy in the next 6 months, or breast-feeding
  • Participating or planning to participate in a commercial diet or behavior modification program (ex: Weight Watchers)
  • Allergy or sensitivity to wheat/grain products or nuts
  • Gastrointestinal disorder.

结局指标

主要结局

Change in body Composition

时间窗: Baseline and endpoint visits (Weeks 0 and 24)

MRI will be used to provide information on total adipose tissue and all adipose tissue sub-compartments: visceral, subcutaneous, intermuscular.

Change in liver Fat

时间窗: Baseline and endpoint visits (weeks 0 and 24)

MRS will be used to provide information on liver adiposity.

次要结局

  • Change in cardio-metabolic risk profile(Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24))
  • Change in brain-derived neutrophic factor (BDNF)(Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24))
  • Change in quality of life(Baseline and endpoint visits (weeks 0 and 24))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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