The Effect of Time-Restricted Eating in Cardiometabolic Health

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University of California, Davis

KLINIK ÇALIŞMA: NCT04484987

BioSeek: nct04484987

Anahtar kelimeler

Öz

Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.

Tarih

Son Doğrulandı:	06/30/2020
İlk Gönderilen:	07/16/2020
Tahmini Kayıt Gönderildi:	07/20/2020
İlk Gönderilen:	07/23/2020
Son Güncelleme Gönderildi:	07/22/2020
Son Güncelleme Gönderildi:	07/26/2020
Fiili Çalışma Başlangıç Tarihi:	07/31/2020
Tahmini Birincil Tamamlanma Tarihi:	08/31/2024
Tahmini Çalışma Tamamlanma Tarihi:	08/31/2025

Durum veya hastalık

Obesity

Pre-diabetes

Müdahale / tedavi

Other: TRE group

Other: Control group

Evre

Kol Grupları

Kol	Müdahale / tedavi
Other: TRE group Time-restricted eating group	Other: TRE group Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Other: Control group Time-unrestricted eating group	Other: Control group Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.

Uygunluk kriterleri

Çalışmaya Uygun Yaşlar	25 Years İçin 25 Years
Çalışmaya Uygun Cinsiyetler	All
Sağlıklı Gönüllüleri Kabul Ediyor	Evet
Kriterler	Inclusion Criteria: - body mass index 27-40 kg/m2 - fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4% - self-reported habitual eating period > 15 h per day Exclusion Criteria: - shift worker, recent or expected travel crossing time zones - fasting >12 h/day more than once a week or vegan - shift worker, recent or expected travel crossing time zones - fasting >12 h/day more than once a week or vegan - > once a week no food intake after 1800 h - habitually waking up before 0400 h and sleeping before 2230 h - ≥ 150 min per week of structured exercise - unstable weight (>5% change the last 2 months) - type 2 diabetes or other major chronic disease - sleep disorder - cancer in last 5 years - conditions that render subject unable to complete all testing procedures - use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.) - smoking and illegal drug use - pregnant or lactating - menopause - individuals that have performed procedures involving substantial exposure to radiation in the last 12 months - gastrointestinal or bariatric surgery - unable to grant voluntary informed consent or comply with the study instructions - individuals who are not yet adults (infants, children, teenagers) - prisoners

Sonuç

Birincil Sonuç Ölçütleri

1. Insulin sensitivity [3 months (pre-post intervention)]

Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.

2. 24 h glycemic control [3 months (pre-post intervention)]

Changes in plasma glucose concentration will be assessed during a 24 h feeding study.

3. Adipose tissue gene expression [3 months (pre-post intervention)]

Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.

İkincil Sonuç Ölçütleri

1. Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells [3 months (pre-post intervention)]

We will evaluate changes in clock gene expression