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Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

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StatusLengkap
Sponsor
UNC Nutrition Research Institute

Kata kunci

Abstrak

People with poor insulin sensitivity do not respond normally to elevations in blood sugar. This may increase their risk of developing diabetes in the future. The purpose of this research study is to determine if the nutrient betaine, found in beets, spinach and wheat products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is believed to promote insulin sensitivity.

Deskripsi

AIM: To determine if betaine is a modulator of FGF21 in humans. Low plasma betaine is associated with an increased risk of metabolic syndrome, but the mechanisms modulating this correlation are poorly delineated. Betaine bioavailability in humans is determined by dietary intake and genetic polymorphisms that influence betaine metabolism. Therefore, moderating betaine levels could be particularly beneficial for some individuals. FGF21 is elevated in response to insulin insensitivity and is under active investigation as a therapeutic modality. The mechanisms of action of FGF21 and betaine on insulin sensitivity in humans are incompletely understood. This study tests the hypothesis that betaine induces FGF21 secretion and insulin sensitizing actions in humans by measuring plasma FGF21, betaine, choline (betaine precursor), glucose, insulin and adiponectin in response to betaine supplementation over a 24 hour time course in 20 healthy, lean individuals. This pilot nutrition intervention will provide key preliminary evidence for understanding whether and how betaine exerts metabolic benefit in humans and will inform a future study to investigate the novel betaine-FGF21-insulin sensitivity axis in a larger cohort.

tanggal

Terakhir Diverifikasi: 07/31/2014
Pertama Dikirim: 04/01/2014
Perkiraan Pendaftaran Telah Dikirim: 04/14/2014
Pertama Diposting: 04/20/2014
Pembaruan Terakhir Dikirim: 08/10/2014
Pembaruan Terakhir Diposting: 08/11/2014
Tanggal Mulai Studi Sebenarnya: 02/28/2014
Perkiraan Tanggal Penyelesaian Utama: 06/30/2014
Perkiraan Tanggal Penyelesaian Studi: 06/30/2014

Kondisi atau penyakit

Insulin Sensitivity

Intervensi / pengobatan

Dietary Supplement: Betaine

Dietary Supplement: Dextrose

Tahap

-

Kelompok Lengan

LenganIntervensi / pengobatan
Active Comparator: Betaine
6 gram dose of betaine delivered in encapsulated form
Dietary Supplement: Betaine
6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage
Placebo Comparator: Dextrose
6 gram dose of dextrose delivered in encapsulated form
Dietary Supplement: Dextrose
6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage

Kriteria kelayakan

Usia yang Layak untuk Belajar 21 Years Untuk 21 Years
Jenis Kelamin yang Layak untuk BelajarAll
Menerima Relawan SehatIya
Kriteria

Inclusion Criteria:

- Healthy

- Able/willing to consume study meals

- Non-smoker

- BMI in normal range (18-24.9)

Exclusion Criteria:

- Use of chronic medications

- Abnormal physical examination or chronic illness

- Use of drugs or medications known to alter choline/betaine metabolism

- Consumption of more than 2 oz of alcohol/day or 24 oz wine/day

- Use of choline/betaine-containing dietary supplements during the previous 3 months

- Diagnosed with Cystathionine Beta-Synthase (CBS) Deficiency

- Pregnant or breastfeeding

- Known hypersensitivity to betaine

- Current substance abuse or addiction

Hasil

Ukuran Hasil Utama

1. Plasma Fetal Growth Factor 21 (FGF21) concentration [0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement]

2. Plasma choline concentration [0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement]

3. Plasma betaine concentration [0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement]

4. Plasma glucose concentration [0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement]

5. Plasma insulin concentration [0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement]

6. Plasma adiponectin concentration [0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement]

Ukuran Hasil Sekunder

1. Typical dietary intake [During day 2 of the first 3 day phase]

Assessed via questionnaire

2. Typical exercise habits [During day 2 of the first 3 day phase]

Assessed via questionnaire

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